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Australian Clinical Trials

Search results from the Australian New Zealand Clinical Trials Registry

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Search Parameters
Broad Health Condition: Cancer
Specific Condition: Myeloma
Recruitment Status: Recruiting

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A Multicentre Phase 3 Trial Comparing Elotuzumab-Cyclophosphamide-Thalidomide-Dexamethasone (E-CTD) with Cyclophosphamide-Thalidomide-Dexamethasone (CTD) for the Treatment of Relapsed and/or Refractory Multiple Myeloma (RRMM)

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Trial Information

Trial summary

PURPOSE
The primary purpose of this study is to determine the efficacy and safety of elotuzumab when combined with cyclophosphamide, thalidomide and dexamethasone (E-CTD) when compared to a standard cyclophosphamide, thalidomide and dexamethasone (CTD) triplet for the treatment of relapsed and/or refractory multiple myeloma (RRMM)

WHO IS IT FOR?
You may be eligible to join this study if you are over 18 years, have been diagnosed with RRMM, have had between 1-3 prior lines of therapy (may include autologous or allogeneic stem cell transplant (induction followed by ASCT and maintenance is one line of therapy), and do not have central nervous system involvement with the disease.

STUDY DETAILS
Enrolled participants who meet the eligibility criteria at registration will be randomised in a 2:1 ratio with 2 patients randomised to the E-CTD arm for every 1 patient randomised to the CTD arm.  Treatment in both arms will include a combination of weekly intravenous infusions, and daily and weekly oral tablets.  Patients will receive treatment in 28 day cycles until disease progression, unacceptable toxicity, or withdrawal or consent.  Patients will be followed up every 4 weeks for MM response until disease progression, and then every 12 weeks for survival.  The trial duration is estimated at approximately 4.75 years.

OUTCOMES
It is hoped that the findings of this trial will determine whether the addition of elotuzumab to a standard cyclophosphamide, thalidomide and dexamethasone triplet will improve progression free survival in relapsed and/or refractory multiple myeloma patients

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
The Alfred - Prahran

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
The Canberra Hospital - Garran

Hospital
The Tweed Hospital - Tweed Heads

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Tamworth Rural Referral Hospital - Tamworth

Hospital
Calvary Mater Newcastle - Waratah

Postcode
3004 - Prahran

Postcode
2485 - Tweed Heads

Postcode
2340 - Tamworth

Postcode
2298 - Waratah

Trial location outside Australia

Country
New Zealand

Anticipated date of first participant enrolment24/10/2016

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Male or female patients 18 years or older.
2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
3. Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 120 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
4. Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:
- Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
5. Patients must abide by thalidomide pregnancy prevention programme
6. Patients must have a diagnosis of a relapsed/refractory multiple myeloma as per IMWG criteria
7. Patients have had between 1-3 prior lines of therapy
- May include autologous or allogeneic stem cell transplant (induction followed by ASCT and maintenance is one line of therapy)
8. No contraindication to the use of any of the study drugs
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 
10. Patient must be greater or equal to 2 weeks from prior chemotherapy, radiotherapy, biological therapy, immunotherapy, major surgery or any other investigational anti-cancer therapy prior to the first dose of study drug
11. Patients must meet the following clinical laboratory criteria:
- Absolute neutrophil count (ANC) greater than or equal to 1,000/mm3 and platelet count greater than or equal to 75,000/mm3.  Subjects who fail screening due to neutropenia or anaemia will not be permitted to use growth factors to become eligible.  Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrolment. 
- Total bilirubin less than or equal to 1.5 x the upper limit of the normal range (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than or equal to 3 x ULN.
- Calculated creatinine clearance greater than or equal to 30 mL/min

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Known thalidomide refractory disease or intolerance
2. Patients with monoclonal gammopathy of uncertain significance or smouldering MM.
3. Patients with primary amyloidosis
4. Patients who have had a prior allogeneic transplantation that requires ongoing immunosuppressive therapy
5. Female patients who are lactating or have a positive serum pregnancy test during the screening period. 
6. Failure to have fully recovered (i.e. less than or equal to Grade 1 toxicity) from the reversible effects of prior chemotherapy.
7. Major surgery or radiotherapy within 14 days before enrolment.
8. Central nervous system involvement.
9. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrolment.
10. Patients who are either contraindicated or unwilling to receive anticoagulation therapy
11. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, New York Heart Association (NYHA) class 3 or 4 heart failure symptoms, unstable angina, or myocardial infarction within the past 6 months.
12. Known ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive, other immunosuppressive therapy or autoimmune disease.
13. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
14. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
15. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of the oral study medications including difficulty swallowing.
16. Diagnosed or treated for another malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease.  Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
17. Patient has greater than or equal to Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
18. Participation in other clinical trials for the treatment of multiple myeloma, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Leukaemia and Lymphoma Group (ALLG)
Primary Sponsor Address: Ground Floor, 35 Elizabeth Street North Richmond, VIC, 3121
Primary Sponsor Country: Australia

Trial IDACTRN12616001030460

Contact person for information and recruitmentMs
Delaine Smith
Australasian Leukaemia and Lymphoma Group (ALLG) Ground Floor, 35 Elizabeth Street, North Richmond, VIC, 3121
+613 8373 9701
+613 9429 8277
Further information icondelaine.smith@allg.org.au
Australia

Single arm, multicentre study of Carfilzomib in combination with Thalidomide and Dexamethasone (CaTD) in patients with relapsed and/or refractory multiple myeloma (RRMM).

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Trial Information

Trial summary

The primary purpose of this study is to determine the efficacy and safety of carfilzomib-thalidomide-dexamethasone (CarTD) therapy for relapsed and/or refractory multiple myeloma (RRMM) patients. Who is it for? You may be eligible to join this study if you are aged over 18 years, have RRMM and have received between one and three lines of therapy previously. Study details The study will recruit participants in Australia and Singapore. All participants will receive 12 x 4-week cycles of CarTD therapy followed by 6 cycles of carfilzomib-dexamethasone only. The first 10 participants recruited in each country will receive a low dose for their first 3 cycles. Depending on the toxicity observed in these participants' first 2 cycles, a higher dose may then be used for their remaining cycles (cycle 4 onwards) and for all cycles in newly recruited participants. Patients will be monitored for myeloma response and safety and tolerability of CarTD therapy using blood samples and by reviewing adverse events that occur as well as for disease progression and survival information for 1 year following the last patients final cycle of treatment. It is hoped that the findings of this trial will provide an evaluation of the efficacy and safety of CarTD therapy in RRMM patients who have relapsed after prior treatment for multiple myeloma.

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
Concord Repatriation Hospital - Concord

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Royal Hobart Hospital - Hobart

Hospital
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne

Hospital
Border Medical Oncology - Albury

Hospital
Royal Darwin Hospital - Tiwi

Postcode
6009 - Nedlands

Postcode
2139 - Concord

Postcode
3000 - Melbourne

Postcode
5000 - Adelaide

Postcode
7000 - Hobart

Postcode
2640 - Albury

Postcode
0810 - Tiwi

Trial location outside Australia

Country
Singapore

Country
Korea, Democratic People's Republic Of

Anticipated date of first participant enrolment30/09/2015

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Male and female patients, > or =18 years of age
2.	Relapsed and/or refractory multiple myeloma at study entry.
3.	Patients must have evaluable multiple myeloma with at least one of the following (assessed within 21 days prior to registration):
a.	Serum M-protein > or = 5 g/L, or
b.	Urine M-protein > or = 200 mg/24 hour, or
In patients without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum k/l ratio or
For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) > or = 7500 mg/L (7.5 g/L).
4.	Received at least one, but no more than three prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
5.	 Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
6.	Adequate hepatic function within 28 days prior to registration with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
7.	Left Ventricular Ejection Fraction (LVEF) > or = 40%.
8.	Absolute neutrophil count (ANC) > or = 1000/mm3 (or 1000 cells/microL) within 21 days prior to registration. Screening ANC should be independent of growth factor support for > or = 1 week.
9.	Platelet count > or = 50,000 cells/mm^3 (> or = 30,000 cells/mm3 if myeloma involvement in the bone marrow is > 50%) within 21 days prior to registration. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
10.	Calculated or measured creatinine clearance (CrCl) of > or =15 mL/min within 21 days prior to registration. Calculation should be based on the Cockcroft and Gault formula 
11.	Written informed consent in accordance with federal, local, and institutional guidelines.
12.	Female patients of child-bearing potential (FCBP) must have negative serum pregnancy test within 21 days prior to registration and agree to use an effective method of contraception during and for 3 months following last dose of drug.
13.	Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to registration, with the exception of dexamethasone up to 160mg or equivalent every 4 weeks.
2.	Previous treatment with carfilzomib.
3.	Focal radiation therapy within 7 days prior to registration. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to registration (i.e., prior radiation must have been to less than 30% of the bone marrow).
4.	Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to registration.
5.	Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to registration.
6.	Known HIV seropositive and/or untreated hepatitis B (patients with hepatitis B surface antigen [HBsAg] and core antibody [HBcAb] are eligible if receiving adequate antiviral therapy directed at hepatitis B).
7.	Patients with known cirrhosis.
8.	Active malignancy, that is expected to require treatment with chemotherapy within one year, or results in a life expectancy less than one year.
9.	Female patients who are pregnant or lactating.
10.	Known history of allergy to Captisol (registered trademark) (a cyclodextrin derivative used to solubilise carfilzomib)
11.	Patients with hypersensitivity to carfilzomib, velcade, boron, or mannitol.
12.	Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to registration.
13.	Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to registration.
14.	Any other clinically significant medical disease or psychiatric condition that, in the Investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australiasian Leukaemia and Lymphoma Group
Primary Sponsor Address: Ground Floor, 35 Elizabeth Street, North Richmond, Victoria, 3121
Primary Sponsor Country: Australia

Trial IDACTRN12615000818538

Contact person for information and recruitmentDr
Hang Quach
Department of Haematology, St. Vincent’s Hospital Melbourne 41 Victoria Parade, Fitzroy VIC 3065
+61 3 9288 2030

Further information iconHANG.QUACH@svha.org.au
Australia

A Phase 2 Clinical Trial of Dichloroacetate in Plateau Phase Myeloma - DiCAM

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Trial Information

Trial summary

This study aims to determine whether 3 months of treatment with oral dichloroacetate can supress multiple myeloma. 

Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Plasma Cell Myeloma which is in a 'Plateau-Phase', i.e. a period of neither progression nor response at least 28 days following the last change in myeloma treatment. 

Study details: All participants in this study will be treated with a drug called dichloroacetate. This will be taken orally (by mouth) daily for 3 months A number of blood samples will be taken throughout treatment in order to determine how the body responds to treatment. This information will help us determine how well dichloroacetate is tolerated, and whether it has the ability to suppress multiple myeloma. 

Broad Health ConditionPlasma Cell Myeloma (aka Multiple Myeloma)

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT

Hospital
The Canberra Hospital - Garran

Postcode
2605 - Garran

Anticipated date of first participant enrolment16/03/2015

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

*Diagnosis of Plasma Cell Myeloma (at any time)     according to WHO criteria
*Aged 18 years or older
*Eastern Co- operative Oncology Group Performance status less than 2
*Life expectancy due to myeloma or co- morbid conditions in the opinion of the treating physician  likely to exceed 3 months 

AND 

*	has measurable residual disease i.e.
**Quantifiable serum paraprotein on electrophoresis at least 1g/L OR
**Elevated free kappa (>21mg/L) or lambda light chains (>30mg/L) AND a minimum difference between level of involved/uninvolved light chain of 150mg/L AND an abnormal serum free light chain ratio  (normal  range = 0.26-1.26) 
AND
*            is in a ‘Plateau- Phase’ i.e.
** A period of neither progression nor response at least 28 days following the last change in myeloma treatment 
**Progression defined as per IWMG 

*an increase in the paraprotein by >= 25% and at least 5g/L 

*In light chain only patients, >25% increase in difference between involved and uninvolved light chain level, with an absolute increase of >0.1g/L 

*development of new lytic lesions

*development of new end organ damage (Renal disease, marrow failure, lytic lesions, hypercalcaemia) attributable to myeloma or new plasmacytomas 

**Response defined as reduction in the paraprotein by at least 25% OR in the case of light chain only myeloma, at least 25% decrease in the difference between the involved and uninvolved light chain and  an absolute reduction of at least 100mg/L.

* Blood samples to assess for plateau phase must be at least 28 days apart

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

*Unable to give informed consent
*Non-secretory myeloma
*Receipt of any active anti-myeloma therapy (excluding bisphosphonates) in the 16 weeks prior to enrolment, with the exception that patients on stable doses of long- term maintenance therapy will be allowed (no dose alteration in the prior 8 weeks).

*Pregnant or breastfeeding
*Unwilling to avoid pregnancy and use birth control (if applicable) during the study and for 4 weeks after completion of the study
*Unable to swallow capsules
*Major surgery within the last 28 days
*Enrolled in another trial or have discontinued from another clinical trial within the last 14 days
*Any  serious pre-existing medical condition that, in the opinion of the study doctor would keep you from being on this trial
*Any peripheral motor or sensory neuropathy, neuralgia or paraesthesia (of grade 3 or worse)
*Any pre-existing severe ataxia or tremor (grade 3 or worse)
*Known history of liver disease (cirrhosis established by imaging studies or biopsy) or abnormal liver function tests within the last 14 days (AST or ALT > 3 x ULN or ALP >2.5 x ULN or total bilirubin > 1.5 x ULN)
*Any more than moderate renal impairment i.e. Calculated Creatinine Clearance by Cockcroft Gault formula of  greater than or equal to 30 mL/min 
*Inadequate cardiac function defined as:
**Electrocardiographic (ECG) evidence of 
***Acute ischemia
***Active clinically significant conduction system abnormalities
***>Grade 2 (>480 ms) (QTc) prolongation
***Uncontrolled angina or severe ventricular arrhythmias
***Myocardial infarction within the last 6 months
***Class 3 or higher New York Heart Association Congestive Heart Failure

*Haematological
**Haemoglobin < 80g/L
**Absolute Neutrophil Count (ANC) less than 1.0 x 10^9/L
**Platelet Count less than 50 x 10^9/L
*Any active fungal, bacterial and/or known active viral infection including HIV or hepatitis (A, B, or C).
*A second malignancy which in the opinion of the investigator may affect the interpretation of results
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Haematology - Capital Region Cancer Services- The Canberra Hospital
Primary Sponsor Address: Capital Region Cancer Services Building Level 5 Yamba Dr, GARRAN ACT 2602
Primary Sponsor Country: Australia

Trial IDACTRN12615000226505

UTN U1111-1166-4468

Contact person for information and recruitmentDr
Samuel Bennett
Haematology Department Capital Region Cancer Services Yamba Dr, GARRAN ACT 2602
+61 2 6174 8547

Further information iconsamkbennett@gmail.com
Australia

Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis With Thrombocytopenia (PAC326)

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Trial Information

Trial summary

This study will compare the chemotherapy drug, Pacritinib, against the best available treatment for Thrombocytopenia and Myelofibrosis. You may be eligible to join this study if you aged 18 years or above and have been diagnosed with thrombocytopenia and/or myelofibrosis. Participants in this study are randomly allocated (by chance) to one of three groups. Participants in the first group will receive one dose of 400mg of oral Pacritinib for 24 weeks or until progression has occurred. Participants in the second group will receive two doses of 200mg of oral Pacritinib daily for up to 24 weeks or until progression occurs. Participants in the third group will receive best available treatment - which will be chosen by your treating physician. Participants will undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans to determine spleen volume and will be assessed for total symptom score using the Myeloproliferative Neoplasm Symptom Assessment Form 2.0. These assessments will occur 12 weekly. Patients may crossover from the BAT (Best available treatment) arm to Pacritinib at the discretion of the Investigator.

Broad Health ConditionPrimary Myelofibrosis

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,WA,VIC

Trial location outside Australia

Country
New Zealand

Country
United States of America

Country
France

Country
United Kingdom

Country
Spain

Country
Hungary

Anticipated date of first participant enrolment1/07/2014

Anticipated date of last participant enrolment30/06/2015

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
Thrombocytopenia (platelet count greater than 100,000/microlitre) at any time after signing informed consent
Palpable splenomegaly greater than 5 cm on physical examination
Total Symptom Score less than 13 on the MPN-SAF TSS 2.0, not including the inactivity question
Patients who are platelet or red blood cell transfusion-dependent are eligible
Adequate white blood cell counts (with low blast counts), liver function, and renal function
At least 6 months from prior splenic irradiation
At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
Not pregnant, not lactating, and agree to use effective birth control
Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Prior treatment with more than 2 JAK2 inhibitors or with pacritinib
More than 6 months of cumulative prior JAK2 inhibitor treatment
History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant
Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
Active bleeding that requires hospitalization during the screening period
Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction
Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers
Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
Life expectancy < 6 months
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Cell Therapeutics Inc.
Primary Sponsor Address: 3101 Western Avenue, Suite 600 Seattle, WA 98121
Primary Sponsor Country: United States of America

Trial websitehttp://www.celltherapeutics.com/

Trial IDACTRN12614000740695

Contact person for information and recruitmentMr
Vince Holmes
Ockham Oncology The Logan Building, Roslin Biocentre, Edinburgh, EH25 9TT United Kingdom
+44 (0)238.032.1226

Further information iconvholmes@ockham.com
United Kingdom

A Phase 1, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered CX-5461 in Patients with Advanced Haematologic Malignancies

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Trial Information

Trial summary

The study is evaluating the maximum tolerated dose (MTD) by understanding the safety profile during incremental dosage escalation.
Who is it for?
You may be eligible to join this study if you are aged over 18 years with any histologically confirmed relapsed or refractory advanced haematologic malignancies for which no effective standard therapies are available, and have progressed following at least one prior treatment regimen. As every blood cancer patient has a unique disease and treatment history, it is highly suggested that you discuss the trial with your haematologist or oncologist who can also contact Peter Mac to determine whether this trial may be suitable for you.

Trial details
Participants in this study will receive CX-5461, an RNA polymerase I inhibitor. CX-5461 will be administered by intravenous infusion over 1 hour every 21 days. Seven dose levels are planned: 25 mg/m2, 50 mg/m2, 100 mg/m2, 170 mg/m2, 250 mg/m2, 330 mg/m2 and 450 mg/m2 per dose. Patients will be assigned to a dose level in the order of study entry.
Participants will be required to undergo various assessment tests including blood, imaging, laboratory and physical assessment tests.

Broad Health ConditionAny advanced Haematologic Malignancy

Specific Health ConditionCancer
Myeloma
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer
Leukaemia - Acute leukaemia

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Institute - East Melbourne

Postcode
3002 - East Melbourne

Anticipated date of first participant enrolment22/07/2013

Anticipated date of last participant enrolment18/07/2016

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients with any histologically confirmed relapsed or refractory advanced haematologic malignancies for which no effective standard therapies are available. These patients must have progressed following at least one prior treatment regimen. There must be evidence of measurable disease.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Pregnant or lactating women, uncontrolled intercurrent illness, history of other malignancy within 2 years of study entry (excluding treated nonmelanotic skin cancer and in-situ carcinoma), known CNS involvement unless previously treated and well controlled for a period of >=3 months and does not require the use of steroids.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Peter MacCallum Cancer Centre
Primary Sponsor Address: St Andrew's Place East Melbourne, Vic, 3002
Primary Sponsor Country: Australia

Trial IDACTRN12613001061729

Contact person for information and recruitmentMs
CX-5461 Trial Manager
Peter MacCallum Cancer Centre Centre for Biostatistics & Clinical Trials East Melbourne 3002
+61-3-96561084

Further information iconribosome@petermac.org
Australia

Pharmacokinetics, pharmacodynamics and pharmacogenomics of busulphan and other agents used in blood or marrow transplantation

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Trial Information

Trial summary

The primary purpose of this trial is to evaluate the relationship between drugs which are administered for blood or bone marrow transplants and the outcomes of the transplant. Who is it for? You may be eligible to enroll in this study if you are receiving intravenous busulphan and/or other conditioning agents prior to a blood or bone marrow transplant. Study details  All participants enrolled in this study will have blood samples taken at different timepoints depending on the institution at which they are receiving treatment, but may be as frequent as weekly until three months following the transplant. Some of the samples will have been taken for clinical reasons and some additional samples are for research.  Participants can choose how many additional samples they will contribute to the study. Researchers will review medical records to evaluate the clinical outcomes of the transplant, and participants will be followed-up for 5 years. It is hoped that by evaluating the concentration of these drugs in the body, and their longterm effects, it may be possible to individualise the dose given to patients to enhance efficacy, reduce toxicity and maximise the chance of disease control.

Broad Health Conditionacute leukaemia
non-Hodgkin Lymphoma
Multiple myeloma
Pharmacokinetics of various chemotherapeutic agents used as conditioning in allogeneic and autologous transplant recipients

Specific Health ConditionCancer
Leukaemia - Acute leukaemia
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer
Myeloma

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,VIC

Hospital
The Children's Hospital at Westmead - Westmead

Hospital
Sydney Children's Hospital - Randwick

Hospital
Westmead Hospital - Westmead

Hospital
Royal Prince Alfred Hospital - Camperdown

Hospital
Liverpool Hospital - Liverpool

Hospital
Peter MacCallum Cancer Institute - East Melbourne

Postcode
2145 - Westmead

Postcode
2050 - Camperdown

Postcode
2170 - Liverpool

Postcode
2031 - Randwick

Postcode
3002 - East Melbourne

Anticipated date of first participant enrolment13/10/2009

Anticipated date of last participant enrolment16/11/2020

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Patients of any age receiving IV busulphan and /or other conditioning agents prior to autologous or allogeneic transplantation to treat both malignant and non-malignant disease. 
2. Patients require adequate venous access preferably with a central venous catheter but will be as per institution’s transplant policy
3.Written informed consent

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Those for whom written informed consent cannot be obtained.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: The Children's Hospital at Westmead
Primary Sponsor Address: Hawkesbury Rd. Westmead, NSW,2145.
Primary Sponsor Country: Australia

Trial IDACTRN12612000544875

Contact person for information and recruitmentDr
Christa Nath
Department of Biochemistry, The Children's Hospital at Westmead, Hawkesbury Rd, Westmead NSW, 2145
61-2-98453287
61-2-98453332
Further information iconchrista.nath@health.nsw.gov.au
Australia

A Phase II trial of bortezomib and dexamethasone in renally-impaired patients with untreated multiple myeloma.

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Trial Information

Trial summary

This study aims to document the rate of renal response and reversal of renal impairment secondary to untreated multiple myeloma (MM) following treatment with Bortezomib and Dexamethasone. This will be done by blood analysis. Patients with untreated multiple myeloma will be selected by physicians. To ensure eligibility to go on trial the patients are required to undergo various blood tests, bone marrow aspirate ad doctor's review before commencing on this treatment. Who is it for? You may be eligible for this study if you are 18 years and over, have renal impairment secondary to MM, defined as a calculated estimated GFR <50ml/min. You must also provide written informed consent prior to the start of study-related procedures. Further details as to whether you are eligible for this study can be found in the inclusion and exclusion criteria within this trial record. Trial details Once you are deemed eligible to take part in this study, you will commence a 21 day cycle of Bortezomib 1.3mg/m2 IV given on days 1, 4, 8, and 11 and Dexamethasone 20mg oral on days 2, 4, 5, 8, 9, 11 and 12 on a 21 day cycle. If your disease does not achieve at least a partial remission after 2 cycles of therapy or shows disease progression at any time, you will be withdrawn from the trial. If you are eligible for high-dose chemotherapy conditioned stem cell transplant and have been responding to therapy, you will receive 4 cycles of therapy before proceeding to your transplant. If you are not eligible for a transplant, you will receive a maximum of 11 cycles of therapy except if you complete remission sooner, in which case you will have Bortezomib therapy ceased after two further cycles and therefore may receive less than 11 cycles of therapy. Treatment efficacy will be monitored throughout the study, at the end of each cycle and at the discretion of your treating doctors.

Broad Health ConditionUntreated Multiple Myeloma patients with renal impairment.

Specific Health ConditionCancer
Myeloma
Blood
Haematological diseases
Renal and Urogenital
Other renal and urogenital disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment8/04/2011

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

- Renal impairment, secondary to MM, defined as a calculated estimated GFR <50ml/min,
- Able to provide written informed consent prior to the start of study-related procedures,
- Subject is, in the investigator's opinion, willing and able to comply with protocol requirements,
- If female, the subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control from signing of informed consent form through to the final visit/early termination visit.
- If male, the subject agrees to use an acceptable barrier method for contraception from signing of the informed consent through to the final visit/early termination visit.
- The patient meets the following pre-treatment laboratory criteria at and within 21 days before baseline:
*Platelet count >50x109/L, with or without transfusion support;
*Haemoglobin >7.0g/dL, with or without transfusion support;
*Absolute neutrophil count (ANC)>/=2.0x109/L;
*Serum calcium <4.5mmol/L (<14mg/dL);
*Aspartate Transaminase (AST) <2.5x the upper limit of normal;
*Alanine transaminase (ALT): <2.5x the upper limit of normal;
*Total bilirubin: <1.5x the upper limit of normal (exceptions will be made for patients diagnosed with Gilbert Syndrome);
*ECOG status 0-3.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

- Use of investigational agents within 28 days of study entry;
- Inadequate hepatic function;
- Severe co-morbidity or othe likely difficulty in completing the study;
- History of allergic reaction attributable to compounds containing boron or mannitol;
- Peripheral neuropathy or neuropathic pain Grade 2-4 defined by NCI CTCAE version 3;
- Uncontrolled or severe cardiovascular disease, including M1 within 6 months of enrolment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis;
- Subject has history of hypotension or has decreasing blood pressure (sitting systrolic blood pressure 
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Prof. Andrew Spencer
Primary Sponsor Address: The Alfred Hospital Malignant Haematology and stem cell transplant Service Ground Floor, William Buckland Building Commercial Road Prahran, 3181
Primary Sponsor Country: Australia

Trial IDACTRN12611000605998

Contact person for information and recruitment
Lisa Di Maio
The Alfred Hospital Malignant haematology and stem cell transplant service Level 1, William Buckland Building Commercial Rd Prahran, Victoria, 3181
+61 3 9076 3038

Further information iconL.DiMaio@alfred.org.au
Australia

A phase II study of lenalidomide and prednisolone as post-autologous stem cell transplant (ASCT) maintenance therapy for patients with Multiple Myeloma incorporating residual disease monitoring.

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Trial Information

Trial summary

A post stem cell transplant maintenance study with lenalidomide in combination with alternate day prednisolone.
All patients will be registered prior to stem cell transplant, be planned for single high dose Melphalan-conditioned stem cell transplant and have no evidence of disease progression at re-staging 6 weeks post transplant.
Oral lenalidomde will commence at a dose of 10mg daily. After 2 months following commencement, escalation or reduction of lenalidomide can be made at the discretion of the treating doctor, depending on tolerance or intolerance of the treatment. Alternate day prednisolone will commence at a dose of 50mg on alternate days with lenalidomide. No dose escalation of prednisolone is planned. Dose reductions are permitted to manage any side effects according to the study protocol. This treatment will continue until unacceptable side effects or disease relapse/progressive disease. 
Pre transplant, all patients will undergo disease restaging with blood tests and bone marrow aspirate. Bloods for serum storage for DNA analysis will be obtained. 6 weeks post transplant patients with adequate recovery will undergo rstaging of their disease with blood testing and bone marrow, to confirm continuing disease response. Patients with disease progression evident on re-staging will not be eligible for treatment on this study. On study, all patients will continue to be evaluated every 4 weeks with repeat blood testsfor response and monitoring until disease progression.

Broad Health ConditionResidual Multiple Myeloma in patients post autologous stem cell transplant.

Specific Health ConditionBlood
Haematological diseases
Cancer
Myeloma

Trial FocusPrevention

Recruitment statusRecruiting

Anticipated date of first participant enrolment9/12/2010

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

At registration pre-ASCT
-Age over 17 years
-Diagnosis of multiple myeloma as per IMWG    
  criteria
-No more than 12 months  total prior standard-
  dose chemotherapy.
-No previous high-dose chemotherapy or
  autologous transplantation procedure.
-ECOG performance status 0, 1, or 2.
-Normal liver and kidney function (within 2 x the 
  institutional upper limit of normal).
-No contraindication to the use of any of the study 
  drugs
-Greater than or equal to 2.0 x 106/kg CD34+ stem cells available for 
  infusion.
-Written informed consent.

To commence RAP post-ASCT
-Have reached Day 42 post-ASCT with evidence of  
  haemopoietic reconstitution (neutrophils > 1.5 x 109/litre  
  and platelets unsupported >50 x 109/litre).
-No evidence of progressive myeloma.
-All women of childbearing potential must agree to 
  have a negative pregnancy test in the 24hrs before 
  commencing lenalidomide, 
  take adequate precautions to prevent pregnancy,
  not plan on conceiving children during or within 6 months  
  following lenalidomide.
-All male participants must use barrier contraception during  
  and for 4 weeks after completion of lenalidomide.
-No contraindication to prednisolone or lenalidomide
-Have an ECOG performance status of 0 – 2.

Minimum age17 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

-Patients with monoclonal gammopathy of uncertain   
  significance.
-Patients with progressive MM pre or post stem cell   
  transplant.
-Patients whose general condition makes them unsuitable 
  for intensive treatment e.g. significant cardiac or 
  pulmonary disease.
-Active infections or other illnesses that would preclude 
  conditioning chemotherapy or maintenance therapy 
  administration or patient compliance.
-Pregnant or lactating women.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Malignant haematology and stem cell transplant Service
Primary Sponsor Address: Prof. Andrew Spencer Malignant haematology and stem cell transplant service The Alfred Hospital Ground Floor, William Buckland Building Commercial Rd Prahran, Victoria, 3181
Primary Sponsor Country: Australia

Trial IDACTRN12611000597998

Contact person for information and recruitment
Nola Kennedy
The Alfred Hospital 1st Floor, William Buckland Building Commercial Rd, Prahran, Victoria, 3181
+61 3 9076 7712

Further information iconN.Kennedy@alfred.org.au
Australia

A Phase II, Open-label, Multi-Dose Study of the Monoclonal Antibody MDX-1097 in Previously Treated Kappa Light Chain Restricted Multiple Myeloma Subjects with Stable Measurable Disease.

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Trial Information

Trial summary

This phase II study is a single centre open-label, multiple dose study intended to determine the preliminary efficacy of MDX-1097. 
Up to 27 previously treated kappa light chain restricted multiple myeloma subjects with stable measurable disease will be enrolled in the study. Weekly i.v. infusion of MDX-1097 for a total of 8 weeks at a dose level of 10 mg/kg is planned for all subjects.  Subjects will be assigned to the clinical trial in the order of study entry.  The study will consist of 3 phases: Screening Phase, Treatment Phase and the Follow-up Phase.

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment29/07/2010

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Subjects with kappa light-chain restricted multiple myeloma  who have received at least one prior line of standard therapy, have achieved at least a minimal response (greater than 25% reduction in M-protein) and had stable measurable disease for at least 3 months prior to study enrollment will be eligible for the study. M protein of greater than or equal to 0.1 g/dL (1 g/L) and/or, 24 hour urinary light chain excretion of greater than or equal to 200 mg, and/or an abnormal free light chain assay (FreeLite assay) demonstrating an excess of kappa free light chains and a kappa: lambda abnormal ratio and/or presence of greater than 20% clonal plasma cells in the bone marrow and/or active skeletal disease based on radiological evaluation or appropriate medical imaging such as computed tomograpy-positron emission tomograpy (CT-PET) scan.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

A positive serum test for human anti-chimeric antibodies (HACA), as determined by Immune System Therapeutics (IST). Clinically relevant active infection or serious co-morbid medical conditions such as recent (6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, difficult to control cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis. Any other active malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the subject has been disease-free for at least 5 years is permissible. Any active or chronic significant infection. Active human immunodeficiency virus (HIV) or hepatitis A, B, or C infection. Pregnant or lactating.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Immune System Therapeutics Limited
Primary Sponsor Address: Level 1, 645 Harris Street Ultimo, Sydney NSW 2007
Primary Sponsor Country: Australia

Trial IDACTRN12610000700033

UTNU1111-1116-4557

Contact person for information and recruitment
Kate Reed
Myeloma Research Group The Alfred Hospital Commercial Road Melbourne Vic 3004
+61 3 92763571
+61 3 9076 5531
Further information iconK.Reed@alfred.org.au
Australia

Study of chromosomal abnormalities by fluorescent in-situ-hyberdisation (FISH), and quantitative polymerase chain reaction (qPCR) in Multiple Myeloma patients and correlations with treatment outcomes.

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Trial Information

Trial summary

This study aims at evaluating the prognostic value of chromosome 13 deletions as well as t(4,14) as detected 
by the FISH/qPCR techniques in multiple myeloma patients. The impact of these abnormalities in the context of high-dose therapy (HDT) or conventional therapy will help to identify those patients who would maximally benefit from HDT and those who would be refractory to HDT and might benefit from other therapeutic options. 
Furthermore, it would be of great value for determining the prognosis of the disease to study the prognostic factors of myeloma, including -13q and t(4;14), at the time of diagnosis, prior to and after transplantation, and at the time of relapse, with special emphasis on the outcome of patients who underwent HDT. 
Moreover, these data might supply valuable guidance regarding identification and cloning of a MM-tumour 
suppressor gene.

Broad Health ConditionChromosomal Abnormalities in Multiple Myeloma

Specific Health ConditionCancer
Myeloma
Blood
Haematological diseases

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/05/2007

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients who are newly diagnosed with multiple myeloma or who has relpased multiple myeloma and are above 18 years old.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients under 18 years. Since this is an observational study, no other exclusion criteria.
Contact details and further information

Sponsor Primary Sponsor Type: Charities/Societies/Foundations
Primary Sponsor Name: Clifford Craig Medical Research Trust
Primary Sponsor Address: PO Box 1963 Launceston Tasmania 7250
Primary Sponsor Country: Australia

Trial IDACTRN12609000594224

Contact person for information and recruitment
Assoc Prof Alhossain Khalafallah
Launceston General Hospital Charles St Launceston Tasmania 7250
+61 3 6348 7111

Further information iconkhalafallah@dhhs.tas.gov.au
Australia

A pilot study of the role of CD133+ as a cell marker for human haematopoietic stem cells

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Trial Information

Trial summary

Therapeutic transplantation of haematopoietic stem cells (HSCs) is an increasing area of interest in medicine. In autologous stem cell transplantation, there is the ability to harvest stem cells soon after chemotherapeutic treatment, and then cryo-preserve and store such cells for stem cell transplantation at a later date. 
CD34 is the typical cell marker used to identify HSCs for transplantation. There exist certain limitations to CD34+ HSCs which include its expression on cells not capable engraftment, and also on acute leukaemic cells. CD133 is an alternative cell surface marker on HSCs which could prove useful in identifying cells for 
transplantation. Preliminary research suggests that CD133 is a more primitive marker, which is expressed by early progenitor cell line, and it has the additional advantage of not being expressed on acute leukaemic 
cells. 
The Launceston General Hospital is the site for stem cell harvest for the North and North-West of Tasmania. 
Annually, approximately 20-30 patients undergo stem cell harvest with the aim of later transplantation. This project is a pilot study to evaluate the value of CD133 in addition to the usual marker CD34+ as a cell marker for HSCs while using the current protocol for stem cell harvest. There is currently little data on the validity of 
CD133 as a HSC marker, and this project, as a part of Master degree at the School of Human Life Sciences at the University of Tasmania, aims to add to the current data and potentially identify the role of CD133 as HSC marker.
We are aiming to study 30-50 patients with different haematological malignancies that require stem cell harvest with subsequent stem cell transplantation during a period of 24 months at the LGH, Tasmania. Current numbers of autologous stem cell harvest at a single centre; the LGH are varied between 20 and 30 episodes per year. Our current autologous stem cell harvest-protocol for patients with malignant haematological disorders is employing mobilisation chemotherapy with cyclophosphamide 5g/m2 and subsequent administration of granulocyte colony stimulating factor (G-CSF) subcutaneously daily at a dose of 10mcg/kg body weight (BW) until harvesting sufficient stem cells per transplant defined as at least 2x106 stem cells/Kg BW. 
We will start to measure both CD 34+ and CD 133+ daily using the flow cytometr (Becton-Dickenson) when the white cell count (WCC) recovers above 1.0/nL post chemotherapy and until the time of stem cell harvest at the Holman Clinic. Thereafter we will measure both markers according to manufacturer reccomendations 
(with commercially available CD34 and CD133 kits) in the harvest product for each patient. Correlation between the amount of harvested CD 34+/CD133+ cells and patient engraftment will be documented for each patient. Using commercially available kits, we are proposing to study the progenitors cells which express 
CD133 antigen by flow cytometry technique according to the manufacturer recommendations as a part of the usual daily measurement of CD34+ cells. There is no additional sample will be required from patients and hence this will not expose the participants to any extra burden. Also we are proposing to measure CD133+ in addition to CD34+ stem cells in the stem cell product garnered by the stem cell harvest. Using flow cytometry to study stem cell characteristics in the leukaphoresis product will provide useful information regarding engraftment kinetics. Platelets engraftment is defined as reaching platelet count>20/nL without substitution, while neutrophil engraftment is defined as reaching neutrophil count above>0.5/nL.

Broad Health ConditionStem cell transplantation

Specific Health ConditionBlood
Haematological diseases
Cancer
Myeloma

Trial FocusDiagnosis

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/03/2008

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients requiring stem cell harvest at the Launceston General Hospital with subsequent stem cell transplantation .

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients under 18 years of age.  People with intellectual or mental impairment.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Launceston General Hospital, Pathology Department
Primary Sponsor Address: charles St Launceston Tasmania, 7250
Primary Sponsor Country: Australia

Trial IDACTRN12609000590268

Contact person for information and recruitment
Assoc Prof Alhossain Khalafallah
Launceston General Hospital Charles St Launceston, Tasmania 7250
+613 6348 7111

Further information iconkhalafallah@dhhs.tas.gov.au
Australia

THRIVING: A randomised controlled trial assessing the efficacy of exercise versus a complementary therapy on the physical and psychosocial outcomes in haematological cancers post treatment

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Trial Information

Trial summary

This study assesses the efficacy of exercise versus a complementary therapy on the physical and psychosocial well-being of people who have undergone treatment for haematological malignancies. 

Who is it for? 
You can join this study if you are undergoing or due to complete  treatment for non Hodgkin's lymphoma (NHL), Hodgkin's Lymphoma (HL) or Myeloma. 

Participants will be randomly divided into 3 groups. The groups will undertake 12 weeks of either exercise, Bowen therapy (a hands-on technique to enhance healing and relieve pain), or 'Wait-listed' supportive care. Participants will be assessed at 0 weeks (pre-), 12 weeks (mid), 24 weeks (post), and there will be the option of a 12 month follow-up. The study aims to measure key physiological and psychosocial outcomes following treatment including quality of life (QoL), anxiety, depression, fatigue, body composition, aerobic fitness and strength.

Broad Health Conditionnon hodgkins lymphoma
myeloma
Hodgkins lymphoma

Specific Health ConditionCancer
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer
Myeloma
Cancer
Hodgkin's

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA

Anticipated date of first participant enrolment1/08/2009

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Undergoing or due to complete chemotherapy treatment for a Haematological cancer (Non-Hodgkin's Lymphoma (NHL), Hodgkin's Lymphoma (HL) or myeloma); doctors approval; pass a pre-exercise screening; written consent

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

have pre-existing cardiac disease or uncontrolled hypertension; unable to participate in a 12 week structured program; unable to understand the implications of their participation; currently engaged in a structed exercise or complementary therapy program; have undergone recent surgery which limits their ability to participate in exercise
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Western Australia (UWA)
Primary Sponsor Address: School of Sport Science, Exercise & Health M408, 35 Stirling Hwy Crawley, WA 6009
Primary Sponsor Country: Australia

Trial websitewww.solariscare.com.au - follow links to research 'Thriving' study www.sseh.uwa.edu.au - follow links to research/thriving study

Trial IDACTRN12609000450213

Contact person for information and recruitment
Bonnie Furzer
School of Sport Science, Exercise & Health M408, 35 Stirling Hwy Crawley, WA 6009
+61 8 6488 1383

Further information iconfurzeb01@student.uwa.edu.au
Australia

An Open-label Phase I Study of the Safety and Efficacy of MDX-1097 in the Treatment of Previously Treated Kappa Light Chain Restricted Multiple Myeloma Patients with Stable Measurable Disease

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Trial Information

Trial summary

This Phase I study is a single-center, open-label, between-patient, single ascending dose study intended to determine the safety, tolerability and maximum tolerated dose (MTD) of MDX-1097.

Broad Health ConditionMultiple myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment4/06/2008

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Diagnosis of kappa light chain restricted multiple myeloma with stable measurable disease.
Serum paraprotein of > 5 g/L, 24 hour urinary light chain excretion of > 200 mg, or demonstration of excess serum free kappa light chains and an abnormal kappa:lambda light chain ratio.
Patients on maintenance therapy for multiple myeloma

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Non-measurable disease by serological measurement, serum free kappa light chains > 250 mg/L, active infections, pregnant or lactating women, any other active malignancy, patients on other investigational agents.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Immune System Therapeutics
Primary Sponsor Address: Level 8, UTS Building 10 235 Jones Street Ultimo NSW 2007
Primary Sponsor Country: Australia

Trial IDACTRN12608000336381

Contact person for information and recruitment
Kate Reed
Myeloma Research Group Alfred Hospital Commercial Road Melbourne VIC 3004
+61 3 92763571

Further information iconK.Reed@alfred.org.au
Australia

A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

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Trial Information

Trial summary

Primary Objectives:

  -  Safety run-in: To confirm the recommended dose of isatuximab when combined with
     lenalidomide and dexamethasone in participants with high-risk smoldering multiple
     myeloma (SMM)

  -  Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination
     with lenalidomide and dexamethasone in the prolongation of progression-free survival
     when compared to lenalidomide and dexamethasone in subjects with high-risk SMM

Secondary Objectives:

Safety run-in

  -  To assess overall response rate (ORR)

  -  To assess duration of response (DOR)

  -  To assess minimal residual disease (MRD) negativity in participants achieving very good
     partial response (VGPR) or complete response (CR)

  -  To assess time to diagnostic (SLiM CRAB) progression or death

  -  To assess time to first-line treatment for multiple myeloma (MM)

  -  To assess the potential immunogenicity of isatuximab

  -  Impact of abnormal cytogenetic subtype

Randomized Phase 3 - Key Secondary Objectives:

To compare between the arms

  -  MRD negativity

  -  Sustained MRD negativity

  -  Second progression-free survival (PFS2)

  -  Overall survival

Other Secondary Objectives:

To evaluate in both arms

  -  CR rate

  -  ORR

  -  DOR

  -  Time to diagnostic (SLiM CRAB) progression

  -  Time to first-line treatment for MM

  -  Safety and tolerability

  -  Pharmacokinetics (PK)

  -  Potential of isatuximab immunogenicity

  -  Clinical outcome assessments (COAs)

Broad Health ConditionAnti-CD38 monoclonal antibody

Specific Health ConditionCancer
Plasma Cell Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,VIC,WA,

Phase of TrialPhase 3

Eligibility

Key inclusion criteria

Inclusion criteria:

    -  Participants who are diagnosed within 5 years with SMM (per International Myeloma
       Working Group [IMWG] criteria), defined as serum M-protein =30 g/L or urinary
       M-protein =500 mg per 24 hour or both, and/or clonal bone marrow plasma cells (BMPCs)
       10% to <60%, and absence of myeloma defining events or other related conditions and
       with high-risk SMM

    -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or 2

    -  Capable of giving voluntary written informed consent

  Exclusion criteria:

    -  Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB)
       criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the
       participants SMM involvement):

         -  Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11
            mg/dL

         -  Renal insufficiency: Determined by glomerular filtration rate (GFR) <40
            mL/min/1.73 m² (Modification of Diet in Renal Disease [MDRD] Formula) or serum
            creatinine >2 mg/dL

         -  Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both)
            transfusion support or concurrent treatment with erythropoietin stimulating
            agents is not permitted

         -  = 1 bone lytic lesion

         -  BMPCs =60%

         -  Serum involved/uninvolved FLC ratio =100 and an involved FLC =100mg/L

         -  Whole body magnetic resonance imaging (WB-MRI) or positron emission
            tomography-computed tomography (PET-CT) with more than 1 bone focal lesion (=5 mm
            in diameter by MRI)

    -  Primary systemic amyloid light-chain (immunoglobulin light chain) amyloidosis,
       monoclonal gammopathy of undetermined significance (MGUS), standard risk smoldering
       myeloma, soft tissue plasmacytoma, symptomatic myeloma

    -  Uncontrolled infection within 28 days prior to randomization in Phase 3 or first study
       intervention administration in safety run-in

    -  Clinically significant cardiac disease, including:

         -  Myocardial infarction within 6 months with left ventricular dysfunction or
            uncontrolled ischemic cardiac disease before Cycle 1 Day 1, or unstable or
            uncontrolled disease/condition related to or affecting cardiac function (eg,
            unstable angina, congestive heart failure, New York Heart Association Class
            III-IV)

         -  Uncontrolled cardiac arrhythmia (Grade 2 or higher by NCI-CTCAE Version 5.0) or
            clinically significant electrocardiogram (ECG) abnormalities

    -  Known acquired immunodeficiency syndrome (AIDS)-related illness or known human
       immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis
       A (defined as positive hepatitis A antigen or positive IgM). HIV serology at screening
       will be tested for German participants and any other country where required as per
       local regulations and serology hepatitis B and C at screening will be tested for all
       participants

         -  Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA

  Of note:

  Patient can be eligible if anti-HBc IgG positive (with or without positive anti-HBs) but
  HBsAg and HBV DNA are negative. If anti-HBV therapy in relation with prior infection was
  started before initiation of IMP, the anti-HBV therapy and monitoring should continue
  throughout the study treatment period.

  Patients with negative HBsAg and positive HBV DNA observed during screening period will be
  evaluated by a specialist for start of anti-viral treatment: study treatment could be
  proposed if HBV DNA becomes negative and all the other study criteria are still met.

  Active HCV infection: positive HCV RNA and negative anti-HCV

  Of note:

  Patients with antiviral therapy for HCV started before initiation of IMP and positive HCV
  antibodies are eligible. The antiviral therapy for HCV should continue throughout the
  treatment period until seroconversion.

  Patients with positive anti-HCV and undetectable HCV RNA without antiviral therapy for HCV
  are eligible

    -  Malabsorption syndrome or any condition that can significantly impact the absorption
       of lenalidomide

    -  Any of the following within 3 months prior to randomization (or first study
       intervention administration in safety run-in cohort): treatment resistant peptic ulcer
       disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease,
       diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event

    -  Received treatment (eg surgery, radiotherapy, medication) for a malignancy within 3
       years of randomization (or first study intervention administration in safety run-in
       cohort)

    -  Prior exposure to approved or investigational treatments for SMM or MM (including but
       not limited to conventional chemotherapies, immunomodulatory imid drugs, or Proteasome
       inhibitors); concurrent use of bisphosphonates or receptor activator of nuclear factor
       kappa-B ligand (RANKL) inhibitor denosumab is not permitted; however, prior
       bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of
       osteoporosis is permitted

    -  Ongoing treatment with corticosteroids with a dose >10 mg prednisone or equivalent per
       day at the time of randomization (or first study intervention administration in safety
       run-in cohort)

    -  Women of childbearing potential or male participant with women of childbearing
       potential who do not agree to use a highly effective method of birth control

    -  Vaccination with a live vaccine 4 weeks before the start of the study drug. Seasonal
       flu vaccines that do not contain live virus are permitted

  The above information is not intended to contain all considerations relevant to a potential
  participation in a clinical trial.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Sanofi

Trial websitehttps://clinicaltrials.gov/show/NCT04270409

Trial IDNCT04270409