Administration of an Allogeneic Myeloma GM-CSF Vaccine in Conjunction with a Lenalidomide Containing Regimen in Myeloma Patients with Near Complete Remission.
This research is being done to find out if we 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.
Study participants must be in a near complete remission on a steady dose of Lenalidomide for at least 6 months. Inclusion Criteria: â?¢Multiple myeloma in near complete remission on a lenalidomide based regimen (lenalidomide or lenalidomide + dexamethasone) for at least 6 months. Patients who are on corticosteroids should discontinue the steroids for 4 weeks and not have evidence of progressive disease after steroids are discontinued. â?¢age greater than 18 â?¢ECOG performance scores 0-2 â?¢ History of measurable serum or urine M protein or free light chains â?¢Life expectancy greater than 12 months â?¢Corrected serum calcium less than 11 mg/dL, and no evidence of symptomatic hypercalcemia â?¢Serum creatinine less than 2 â?¢ANC greater than 1000 â?¢Platelet greater than 100,000 â?¢Total bilirubin ï?£ 1.5 x ULN â?¢AST (SGOT) and ALT (SGPT) ï?£ 3 x ULN. â?¢Negative pregnancy test if applicable â?¢Ability to comprehend and have signed the informed consent. â?¢Disease free of prior malignancies for less than 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma â??in situâ?? of the cervix or breast. â?¢All study participants must be registered into the mandatory RevAssistÂ® program, and be willing and able to comply with the requirements of RevAssistÂ®. â?¢Females of childbearing potential (FCBP)â? must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 â?? 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. â?¢Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). Exclusion Criteria: â?¢Disease progression after stopping corticosteroids as defined as the appearance of an M-spike greater than 0.1g/dL â?¢Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, non-secretory myeloma and amyloidosis. â?¢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. â?¢Patients who have participated in any clinical trial, within four weeks prior to registration on this trial, which involved an investigational drug. â?¢History of an active malignancy other than myeloma â?¢Autoimmune disease requiring active treatment. â?¢History of an autologous stem cell transplant within the past 12 months or less â?¢History of an allogeneic transplant
Participants in this research, will continue on lenalidomide therapy but will be asked to discontinue the steroids (dexamethasone). They will also receive an investigational multiple myeloma vaccine at four different time points. These time points will occur during cycles 1, 2, 3, and 6 of treatment. They will also need to have a bone marrow biopsy at screening, middle of cycle 3, middle of cycle 6, and one year after starting therapy.
05/19/2013 04:02 AM