Lenalidomide after Donor Stem Cell Transplant and Bortezomib in Treating Patients with High Risk Multiple Myeloma

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 such as 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 * Myeloma Prognostic Risk Score (MyPRS) gene expression score equal or higher than 45.2 * High risk 70 gene expression profile (MyPRS GEP70^TM) * 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 18-50
• 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 50 mL/min or higher
• All study participants must be registered into the mandatory Revlimid risk evaluation and mitigation strategy (REMS) program, and be willing and able to comply with the requirements of Revlimid REMS
• 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
• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)

Exclusion Criteria

• 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
• 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