Title A Study of Low-dose Lenalidomide after Non-myeloablative Allogeneic Stem


CC 13-870

Hospital Main Campus

Disease Blood & Marrow Transplant (BMT), Multiple Myeloma

Drug Lenalidomide (Revlimid), Pemetrexed



Primary Objective

  1. Identify the maximal tolerated dose (MTD) and safety of lenalidomide up to 10mg following non-myeloablative allogeneic stem cell transplant for multiple myeloma

Secondary Objectives

  1. Assess safety and tolerability of weekly bortezomib following alloHSCT
  2. Obtain estimates of TRM
  3. Obtain estimates of acute and chronic GVHD
  4. Obtain estimates of 1 year relapse and survival
Inclusion Criteria

Inclusion Criteria

  1. Symptomatic multiple myeloma by International Myeloma Working Group (IMWG) criteria according to the most recent updated version (IMW meeting in Paris 2011)
  2. Must have received at least 3 of the following classes of anti-myeloma agents either alone or in combination: glucocorticoids, immunomodulatory drugs such as thalidomide, proteasome inhibitors, alkylating chemotherapy, or anthracyclines
  3. Must meet any of these criteria for high risk disease:
    • Relapse or progressive disease according to uniform response criteria within 2 years after starting first-line therapy or within 2 years after autologous stem cell transplant
    • Failure to achieve PR within 6 months of starting first-line therapy
    • Presence of high risk cytogenetic features (t(14;16), t(14;20), deletion 17p)
    • Chromosome 14 translocations other than to Chromosome 11
    • Chromosome 1p deletion and 1q amplication
    • MyPRS gene expression score equal or higher than 45.2
    • High risk 70 gene expression profile (MyPRS GEP70TM)
    • Any other high risk genetic profile that is determined by future IMWG consensus or by internal myeloma panel consensus; for the latter, any additional criteria will be submitted as an addendum
    • Diagnosed with multiple myeloma between the ages of 18-45
  4. Must have achieved at least a minor response to any previous regimen according to adapted EBMT criteria (section 7)
  5. Must have suitable matched sibling or matched unrelated donor for stem cell source
  6. Must be transplant-eligible per institution guidelines
  7. Must have estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) formula or Cockroft-Gault formula of 50mL/min or higher
  8. All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®
  9. Females of childbearing potential (FCBP) - must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS®) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
  10. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
  11. Must be ages 18-65 and older
Exclusion Criteria

Exclusion Criteria

Participants must not:

  1. Have known hypersensitivity to thalidomide or lenalidomide
  2. Have progressive disease at the time of transplant
  3. Uncontrolled concurrent significant medical or psychological co-morbidity
  4. Grade 3 peripheral neuropathy
  5. Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
  6. Females who are pregnant.
  7. Recent (within 3 years) history of other malignancies, excluding basal cell carcinoma or squamous cell carcinoma of the skin
  8. Be currently enrolled in another investigational treatment protocol