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
- 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
- ANC >1000/µL
- Platelet >100,000/µL
- 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
- 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
- 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
- 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
- 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