Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide Compared to Lenalidomide Alone in Multiple Myeloma Patients
What is the purpose of this trial?
The investigator's primary objective is to compare the 2-year progression free survival of patients treated with lenalidomide alone or in combination with vaccine.
Patients will be randomized to receive either lenalidomide alone or in combination with vaccine. Patients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter. All patients will be followed for a minimum of 3 years.
The following criteria is provided for health care professionals.
Myeloma eligibility criteria are the following:
Near complete remission (nCR) for ≥ 3 months defined as no measurable M-spike, and a positive serum immunofixation
Or complete remission (CR) (no measurable M-spike, immunofixation negative and bone marrow plasma cells <5%)
NDMM or RMM in nCR or CR having completed a minimum of 6 cycles of a lenalidomide based regimen for a minimum of ≥ 3 months
NDMM or RMM a patients who have been off corticosteroids for ≥ 4 weeks
Patients with NDMM or RMM who have had autologous stem cell transplant are eligible, but must be ≥ 12 months from transplant
Age > 18 years
ECOG performance scores 0-2
History of measurable serum or urine M protein or free light chains
Life expectancy greater than 12 months
Corrected serum calcium < 11 mg/dL, and no evidence of symptomatic hypercalcemia
Serum creatinine< 2 mg/dl
Total bilirubin <= 1.5 x ULN
AST (SGOT) and ALT (SGPT) <= 3 x ULN.
Ability to comprehend and have signed the informed consent.
Have previously agreed to continue on maintenance therapy with lenalidomide concurrent with vaccine administration until disease progression, or clinical indication to cease therapy.
Disease free of prior malignancies for at least 5 years with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the uterus, cervix or breast.
All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
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 prior to starting lenalidomide with each cycle (prescriptions must be filled within 7 days) 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 prophylactic anticoagulation (aspirin 81 or 325 mg/daily or, for patients intolerant to ASA, warfarin or low molecular weight heparin).
Disease progression after stopping corticosteroids as defined as the appearance of a detectable serum or urine M-spike, or an absolute increase of >10 mg/dl between involved and uninvolved light chains, in the absence of measurable serum or urine M-protein .
Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, CNS involvement, non-secretory myeloma and amyloidosis
High-risk myeloma defined by presence of at least one of the following defining features on initial diagnostic, or most recent bone marrow biopsy:
High risk chromosomal translocations by FISH: t(4;14), t(14;16), t(14;20),
del(17p), del(1p), amplification 1q.;
MyPRS GEP-70 high risk signature either from diagnosis or at time of registration for the study;
LDH > 300 U/L at diagnosis;
Relapse from prior therapy within 12 months.
HIV disease, active infection requiring treatment with antibiotics, anti-fungal or anti-viral agents within 2 weeks of enrollment would be excluded from the study.
Patients who have participated in any clinical trial, within the last four weeks, which involved an investigational drug.
History of an active malignancy other than myeloma
Autoimmune disease requiring active treatment.
Known contra-indication to any component of allogeneic myeloma vaccine
History of an allogeneic transplant
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