Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma
About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Symptomatic multiple myeloma by International Myeloma Working Group (IMWG) criteria according to the most recent updated version (International Myeloma Workshop [IMW] meeting in Paris 2011)
- Must have received at least 3 of the following classes of anti-myeloma agents either alone or in combination: glucocorticoids, immunomodulatory drugs including thalidomide, proteasome inhibitors, alkylating chemotherapy, or anthracyclines
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 partial response (PR) within 6 months of staring 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 amplification
- 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
- Diagnosis with multiple myeloma between the ages of 18-50
- Must have achieved at least a minor response to any previous regimen according to adapted European Group for Blood and Marrow Transplantation (EBMT) criteria
- Must have suitable matched sibling or matched unrelated donor for stem cell source
- Must be transplant-eligible per institution guidelines
- 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
- 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®
- Females of childbearing potential must have negative serum or urine pregnancy test and use acceptable birth control methods
- Able to take aspirin daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Exclusion Criteria:
Participants must not:
- Have known hypersensitivity to thalidomide or lenalidomide
- Have progressive disease at the time of transplant
- Uncontrolled concurrent significant medical or psychological co-morbidity
- Grade 3 peripheral neuropathy
- 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
- Be females who are pregnant
- Recent (within 3 years) history of other malignancies, excluding basal cell carcinoma or squamous cell carcinoma of the skin
- Be currently enrolled in another investigational treatment protocol
Sites / Locations
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (nonmyeloablative alloHSCT, lenalidomide)
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate on days -5 to -3 and undergo TBI on day -1. TRANSPLANT: Patients undergo allogeneic hematopoietic SCT on day 0. GVHD PROPHYLAXIS: Patients receive standard GVHD prophylaxis comprising cyclosporine PO BID beginning on day -1 with taper beginning on day 100, mycophenolate mofetil PO BID on days 1-56, and bortezomib SC weekly from day 1 to day 91. MAINTENANCE THERAPY: Beginning on day 100, patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.