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Clinical Trial Details

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

Broad Health Condition Cancer

Specific Health ConditionMyeloma

Trial FocusTreatment

Recruitment statusRecruiting

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

Hospital
Sir Charles Gairdner Hospital - Nedlands
Concord Repatriation Hospital - Concord
Peter MacCallum Cancer Centre - Melbourne
The Royal Adelaide Hospital - Adelaide
Royal Hobart Hospital - Hobart
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Border Medical Oncology - Albury
Royal Darwin Hospital - Tiwi


Postcode
6009 - Nedlands
2139 - Concord
3000 - Melbourne
5000 - Adelaide
7000 - Hobart
2640 - Albury
0810 - Tiwi


Trial location outside Australia
Singapore
Korea, Democratic People's Republic Of

Anticipated date of first participant enrolment30/09/2015

Anticipated date of last participant enrolment30/09/2015

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

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.
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