Melphalan and Stem Cell Transplant Before Total-Body Irradiation and Donor Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma
About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: Meet Salmon and Durie criteria for initial diagnosis of multiple myeloma; transplant will be offered to patients with stage II or III multiple myeloma (MM) at diagnosis or have received chemotherapy and/or radiation therapy for progressive MM after initial diagnosis of stage I disease The patient must have the capacity to give informed consent Have received at least 4 cycles of conventional dose chemotherapy for MM DONOR: HLA genotypically identical sibling DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for both peripheral blood stem cell (PBSC) allograft and subsequent DLI DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian) DONOR: Age < 75, older donors may be considered after consultation by Psychological Consultation Center (PCC) Exclusion Criteria: Karnofsky score less than 60, unless due solely to myeloma Left ventricular ejection fraction less than 40% Bilirubin greater than 2 X the upper limit of normal Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) > 2 X the upper limit of normal Diffusion lung capacity of carbon monoxide (DLCO) < 50% (corrected) or receiving continuous supplemental oxygen Patients with poorly controlled hypertension Pregnancy Seropositive for the human immunodeficiency virus Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment Creatinine clearance < 40 cc/min at the time of initial autografting evaluation Prior autograft (can be treated on alternative protocol) DONOR: Identical twin DONOR: Age less than 12 years DONOR: Pregnancy DONOR: Infection with human immunodeficiency virus (HIV) DONOR: Inability to achieve adequate venous access DONOR: Known allergy to G-CSF DONOR: Current serious systemic illness DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for stem cell donation as described in the standard practice guidelines of the institution
Sites / Locations
- City of Hope
- University of Colorado
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- University of Torino
Arms of the Study
Arm 1
Experimental
Treatment (Melphalan and PBSCT before TBI and Donor PBSCT)
CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 15-20 minutes on day -2. TRANSPLANTATION: Patients undergo autologous bone marrow or PBSCT on day 0. NON-MYELOABLATIVE CONDITIONING REGIMEN: Beginning 40-120 days after autologous transplant, patients undergo TBI on day 0. TRANSPLANTATION: Patients undergo donor PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV BID on days -1 and 0 and PO BID on days 1-80 with taper based on evaluation of disease response and GVHD. Patients also receive mycophenolate mofetil PO BID on days 0-27. POST TRANSPLANT DLI: Beginning 4 weeks after immunosuppression, patients achieving persistent or progressive disease may undergo DLI over 30 minutes every 4 weeks for up to 3 treatments.