Chemotherapy, Vaccine Therapy, and Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
INCLUSION CRITERIA Initial Presentation Age between 18 and 70 years ECOG 0 - 2 Patients with histologically confirmed multiple myeloma with ≥ 30% bone marrow involvement and a de novo presentation. One cycle of prior chemotherapy for myeloma is allowed. Local radiation therapy is permitted Ability to give informed consent No existing secondary malignancies and no history of secondary malignancies in the past 5 years (other than a history of carcinoma in situ of the cervix, superficial skin cancer, or superficial bladder cancer) No active autoimmune disease, nor a history of any autoimmune disease requiring medical treatment with systemic immunosuppressants No corticosteroids within 28 days of tumor harvest No major active medical or psychosocial problems that could be exacerbated or complicated by this treatment Not pregnant HIV negative AST/ALT, total bilirubin < threefold normal Absolute neutrophil count >500/mm3 Platelet count >30,000/mm3 Prior to Transplantation ECOG performance status of 0 - 2. No active/uncontrolled infection. Absolute neutrophil count (ANC) >1000/mm3. Platelet count >50,000/mm3. Hemoglobin >8g/dL AST/ALT, total bilirubin <3-fold normal. 50% or greater reduction in tumor burden with prior chemotherapy Patient has received a minimum of 2 cycles of an accepted induction chemotherapy regimen Patient fulfills the requirements for standard peripheral stem cell transplantation Prior to Posttransplant Vaccination No active/uncontrolled infection Absolute neutrophil count (ANC) >1000/mm3 Platelet count >50,000/mm3 Hemoglobin >8g/dL AST/ALT, total bilirubin <3-fold normal No unresolved Grade 3 or 4 adverse events related to the transplant EXCLUSION CRITERIA • Failure of autologous tumor-cell processing for vaccine production
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Experimental
Vaccine
Participants are vaccinated with GVAX one month or more after finishing induction therapy (which is given as per standard of care). Two weeks later, participants go through leukapheresis on protocol, then receive autologous transplant as per standard of care. GVAX is administered eight subsequent times after the autologous transplant.