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Australian Clinical Trials

Clinical Trial Details

An ALLG Trial to compare the use of Selinexor with Lenalidomide and Lenalidomide alone for patients with newly diagnosed Multiple Myeloma undergoing Autologous stem cell transplant.

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionMyeloma

Trial FocusTreatment

Recruitment Details

Recruitment status
Recruiting

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

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
The Alfred - Melbourne
Austin Health - Austin Hospital - Heidelberg
Barwon Health - Geelong Hospital campus - Geelong
Princess Alexandra Hospital - Woolloongabba
Townsville University Hospital - Douglas
Monash Medical Centre - Clayton campus - Clayton
Concord Repatriation Hospital - Concord
Peter MacCallum Cancer Centre - Melbourne
Border Medical Oncology - Albury
Fiona Stanley Hospital - Murdoch
Lismore Base Hospital - Lismore
Orange Health Service - Orange
Launceston General Hospital - Launceston
Western Hospital - Footscray - Footscray
The Royal Adelaide Hospital - Adelaide
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Royal Hobart Hospital - Hobart

Postcode
3065 - Fitzroy
3004 - Melbourne
3084 - Heidelberg
3220 - Geelong
4102 - Woolloongabba
4814 - Douglas
3168 - Clayton
2139 - Concord
3000 - Melbourne
2640 - Albury
6150 - Murdoch
2480 - Lismore
2800 - Orange
7250 - Launceston
3011 - Footscray
5000 - Adelaide
2010 - Darlinghurst
7000 - Hobart

Trial location outside Australia
New Zealand

Anticipated date of first participant enrolment3/08/2020

Anticipated date of last participant enrolment18/01/2024

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Trial summary

The purpose of this study to determine whether the addition of selinexor to lenalidomide maintenance therapy post Autologous Stem Cell Transplant for multiple Myeloma patients increases the proportion of patients who are progression free 3 years post randomisation.

Who is it for?

You may be eligible for this study if you are an adult who has been newly diagnosed with Multiple Myeloma and are eligible for an Autologous Stem Cell Transplant.

Study details

Participants in this study will be randomised to receive either:
Lenalidomide 10mg,orally,once a day for 21 days
or
Lenalidomide 10mg,orally,once a day for 21 days with Selinexor 40mg,orally, weekly

Lenalidomide may be increased to 15mg orally, once a day for 21 days from cycle 4 onwards, provided good tolerance and no lenalidomide-related greater than or equal to grade 3 adverse events.

Selinexor may be maintained at 40mg orally, weekly from cycle 2 onwards provided good tolerance and no selinexor-related greater than or equal to grade 3 adverse events
Each cycle lasts 28 days,

Patients will receive treatment until disease progression.

During the trial patients will have blood tests performed and bone marrow samples taken to help determined the progress of the treatment.

It is hoped that this research will help determine whether this treatment prolongs the progression free survival for patients, and what kinds of side effects/complications may occur with this treatment.

Eligibility

Key inclusion criteria

• Patient must be 18 years of age or older
• Patient has voluntarily agreed and has given written consent to both the main study and 
   correlative study
• Diagnosis of MM as per IMWG guidelines (Appendix 3)
• Must be eligible for front-line melphalan conditioned ASCT
• Will have undergone at least 3-6 cycles of up-front therapy containing a proteasome 
  inhibitor (PI) and/or immunomodulatory drug (IMID) and ASCT (tandem transplants 
  allowable) prior to screening procedures (note consent and registration will occur prior to 
  ASCT
• Pre-ASCT (preferably prior to and if not, as early as possible during induction therapy) 
   bone marrow aspirate trephine for correlative studies. Patients who are unable to provide 
   pre ASCT BMAT samples for correlative studies can be enrolled into the study if a waiver 
   is granted from the coordinating principal investigator
• Measurable disease at diagnosis:
   • Serum M-protein greater than or equal to 5 g/L, or
   • Urine M-protein greater than or equal to 200 mg/24 hour, or
   • In patients without measurable serum or M-protein, serum free light chain (SFLC) 
     greater than 100mg/L (involved light chain) and an abnormal serum k/l ratio or
   • In IgA patients whose disease can only be reliably measured by serum quantitative 
      immunoglobulin (qIgA) greater than or equal to 7500 mg/L (7.5 g/L).
• Female patients who are postmenopausal for at least 1 year prior to screening visit OR 
   surgically sterile OR agree to practice 2 effective methods of contraception at the same 
   time from 4 weeks before start of study treatment and until 90 days after the last dose of 
   study drugs OR agree to practice true abstinence when this is in line with the preferred 
   and usual lifestyle of the subject.
• Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to 
   practice effective barrier contraception during the entire study treatment period and 
   through 90 days after the last dose of study drug, OR to practice true abstinence when 
   this is in line with the preferred and usual lifestyle of the subject.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix 2).
• Subjects must agree not to donate blood, semen or sperm while on study and at least 90 
  days after treatment discontinuation.
• Subjects must agree not to share their medication and to return unused supplies.
• Patients must meet the following clinical laboratory criteria:
  o Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L and platelet count 
     greater than or equal to 100 x10^9/L. Platelet transfusions to help patients meet 
     eligibility criteria are not allowed.
  o Total bilirubin less than or equal to 1.5 x the upper limit of the normal range (ULN)
  o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal 
     to 3 x ULN.
  o Calculated creatinine clearance greater than or equal to 30 mL/min per Cockcroft-Gault 
     equation.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

• Pregnant or lactating women.
• Failure to have fully recovered (i.e. less than or equal to Grade 1 toxicity) from the 
   reversible effects of prior chemotherapy.
• Progressive disease post-ASCT.
• Major surgery within 14 days before enrolment.
• Radiotherapy within 14 days before enrolment. If the involved field is small, 7 days will be 
   considered a sufficient interval between treatment and administration of the selinexor.
• Central nervous system involvement.
• Active infection requiring iv antibiotics in 5 days prior to starting study therapy.
• Subjects with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B 
  has been given for >8 weeks and viral load is <100 IU/ml prior to first dose of trial 
  treatment. Subjects with untreated hepatitis C virus (HCV) are not allowed. Subjects with 
  Human Immunodeficiency Virus (HIV) who have CD4+ T-cell counts greater than or equal 
  to 350 cells/µL and no history of AIDS-defining opportunistic infections in the last year are 
  allowed.
• Any serious medical or psychiatric condition (including uncontrolled infection) that could, 
  in the investigator’s opinion, potentially interfere with the completion of treatment 
  according to this protocol or would be a contraindication to consolidation/maintenance 
  therapy.
• Known allergy to any of the study medications, their analogues, or excipients in the 
   various formulations of any agent.
• Known GI disease or GI procedure that could interfere with the oral absorption or 
   tolerance of study medications including difficulty swallowing.
• Patient has greater than or equal to 2 grade peripheral neuropathy or grade 1 with pain on 
   clinical examination during the screening period.
• Participating in other clinical trials, 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.
• Contraindication to the use of either lenalidomide or selinexor.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australian Leukeamia and Lymphoma Group (ALLG)
Primary Sponsor Address: ALLG 35 Elizabeth St Richmond Victoria 3121
Primary Sponsor Country: Australia

Trial IDACTRN12620000291987

Contact person for information and recruitmentMs
Delaine Smith
ALLG 35 Elizabeth Street Richmond Victoria 3121
+61 3 8373 9701

Email contact Further information icondelaine.smith@allg.org.au

Australia