Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
Multiple Myeloma

About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Immunoablative, Mobilization, Apheresis, Multiple Myeloma, IgG Multiple Myeloma, IgA Multiple Myeloma
Eligibility Criteria
INCLUSION CRITERIA: Collection of plasma in recipient: Patients with Immunoglobulin G (IgG) or Immunoglobulin A (IgA) multiple myeloma. Patients have siblings. Human leukocyte antigen (HLA) typing of recipient and donor(s) initiated. Viral antibody screening initiated. INCLUSION CRITERIA: Recipient: Patients with IgG or IgA multiple myeloma. Patients must have achieved at least a partial remission following initial conventional chemotherapy regimen or after autologous stem cell transplantation. Patients who have undergone tandem autologous stem transplants are eligible if they meet all other eligibility criteria. Patients who have achieved at least a partial remission to initial (primary) conventional chemotherapy will be encouraged to proceed to autologous transplantation, but will also be eligible for this protocol. Patients 18-75 years of age. The upper age limit was chosen as it is felt that the toxicities would exceed potential benefit in this older population. Karnofsky performance status greater than or equal to 80%. Life expectancy greater than 6 months. Left ventricular ejection fraction has to be greater than 50% by either multi-gated acquisition scan (MUGA) or 2-D echo. Carbon monoxide diffusing capacity (DLCO) greater than 50% of the expected value when corrected for hemoglobin (Hb)(96). Creatinine less than or equal to 1.5 mg/dl and a creatinine clearance greater than or equal to 50 ml/min. Direct bilirubin less than or equal to 2.0 mg/dl serum glutamic oxaloacetic transaminase (SGOT) less than 4x top normal. M-protein: the concentration in the harvested plasma must be greater than 70% of the total Ig of the corresponding isotype. Patients must be human immunodeficiency virus (HIV)-negative. There is the theoretical possibility that the degree of immune suppression associated with the treatment may result in progression of HIV infection. Patients may be Hepatitis B core antigen positive, but surface antigen negative and without evidence of active infection. Patients must be Hepatitis C negative. Not pregnant or lactating. Patients of childbearing potential must use an effective method of contraception. The effects of the chemotherapy, the subsequent transplant and the medications used after the transplant are highly likely to be harmful to a fetus. The effects upon breast milk are also unknown and may potentially be harmful to the infant. Consenting first degree relative matched at 6/6 or 5/6 HLA antigens, this may include a mismatch at the D locus. Ability to give informed consent. INCLUSION CRITERIA: Donor: Age 18-75 years. As the potential cerebrovascular and cardiac complications may potentially increase with age, age 75 has been chosen arbitrarily as the upper age limit. However, if it is determined after initial accrual of patients in this upper age range that this procedure is relatively safe, the age range may be extended. No physical contraindications to stem cell donation (i.e. severe atherosclerosis, auto-immune disease, cerebrovascular accident, active malignancy (97). Patients with severe atherosclerosis by history will receive a cardiology consult and be judged eligible on a case by case basis. Donors must be HIV-negative, hepatitis B surface antigen (HBsAg-), and Hepatitis C antibody negative. This is to prevent the possible transmission of these infections to the recipient. Not pregnant or lactating. Donors of childbearing potential must use an effective method of contraception. The effects of cytokine administration on a fetus are unknown and may be potentially harmful. The effects upon breast milk are also unknown and may potentially be harmful to the infant. Normal cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) numbers as defined by Clinical Center standards. Ability to give informed consent.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Recipient - Chemotherapy Group
Donor - Vaccine Generation Group
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor (GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination.