Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma (07-REV)

Inclusion Criteria:

• One prior allograft from an 8/8 or 7/8 allele matched related or unrelated donor, received 60 to 90 days prior to initiation of lenalidomide
• Meet the diagnostic criteria of symptomatic myeloma at anytime prior to allogeneic HCT
• Have high-risk multiple myeloma
• Received ≤ three (3) prior lines of therapy. Prior therapies may include: combination chemotherapy, monotherapy, lenalidomide and autologous HCT. Localized radiation therapy does not count as a single line of therapy. Previous progression on lenalidomide does not exclude participation in the study.
• Received a reduced intensity conditioning regimen
• Received or are receiving a GVHD prophylaxis regimen of a calcineurin inhibitor in combination with either methotrexate, mycophenolate mofetil (MMF) or sirolimus
• Karnofsky performance score ≥ 80 or ECOG ≤ 2
• There must be at least 50% donor chimerism and no evidence of falling donor chimerism within 1 month of enrollment
• Laboratory test results within range, within 14 days prior to initiation of lenalidomide
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

Exclusion Criteria:

• Disease progression at time of study entry
• Patients with any grade III-IV GVHD at the time of study entry
• Patients requiring additional immunosuppressive therapy to control acute GVHD other than corticosteroids and immunosuppressive agents used for prophylaxis.
• Concomitant use of other investigational agents
• Patients who have received donor lymphocyte infusions
• Active CNS malignancy
• Uncontrolled bacterial, viral, or fungal infections
• Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ < 5 years from study entry.
• Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.
• Known positive for HIV or active infectious hepatitis.
• Women who are pregnant or breastfeeding.
• New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.