Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Allogeneic Myeloma Vaccine; Prevnar-13
Intervention description: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).; A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.; Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
Intervention MeSH terms: Lenalidomide; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research is being done to find out if the investigators can improve outcomes for
      multiple myeloma patients by giving a myeloma vaccine to patients who are already on
      lenalidomide (Revlimid) and in a near complete remission.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Myeloma eligibility criteria are the following:

               -  sustained near complete remission (nCR) for 4 months defined as no measurable
                  M-spike and a positive immunofixation

               -  early biochemical relapse as manifest by going from a true CR (immunofixation
                  negative) to a nCR (immunofixation positive) at any time

               -  conversion from a nCR to the appearance of a monoclonal spike in the serum not
                  greater than 0.3mg/dL

          -  age 18 years and older

          -  Eastern Cooperative Oncology Group 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

          -  Absolute Neutrophil Count >1000

          -  Platelet >100,000

          -  Total bilirubin less than or equal to 1.5 x Upper limit of normal

          -  Aspartate aminotransferase and Alanine transaminase less than or equal to 3 x Upper
             limit of normal

          -  Negative pregnancy test if applicable

          -  Ability to comprehend and have signed the informed consent.

          -  Disease free of prior malignancies for < 5 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
             or breast.

          -  All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®.

          -  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
             and again within 24 hours of prescribing lenalidomide (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. See Appendix: Risks of Fetal Exposure, Pregnancy Testing
             Guidelines and Acceptable Birth Control Methods.

          -  Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
             intolerant to aspirin may use warfarin or low molecular weight heparin).

        Exclusion Criteria:

          -  Disease progression after stopping corticosteroids as defined as the appearance of an
             M-spike >0.5g/dL

          -  Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, non-secretory
             myeloma and amyloidosis.

          -  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 four weeks prior to
             registration on this trial, 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 Prevnar 13 including the diphtheria
             toxoid-containing vaccine.

          -  History of latex allergy

          -  History of an autologous stem cell transplant within the past 12 months or less

          -  History of an allogeneic transplant