Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)
Multiple Myeloma

About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm
Eligibility Criteria
Inclusion Criteria: Meeting the Durie and Salmon criteria for initial diagnosis of MM Stage II or III MM at diagnosis or anytime thereafter Symptomatic MM requiring treatment at diagnosis or anytime thereafter Received at least three cycles of initial systemic therapy and are within 2-10 months of initiation of the initial therapy (this time frame excludes the time for mobilization therapy) If receiving chemotherapy-based mobilization regimens, must be able to receive high-dose melphalan between 2 and 8 weeks after the initiation of mobilization therapy whether delivered at the transplant center or at a referring center Adequate organ function as measured by: Cardiac: Left ventricular ejection fraction at rest greater than 40% Hepatic: Bilirubin less than 2 times the upper limit of normal and alanine transaminase (ALT) and aspartate transaminase (AST) less than 3 times the upper limit of normal Renal: Creatinine clearance greater than 40 ml/min (measured or calculated/estimated) Pulmonary: Carbon monoxide diffusion (DLCO), Volume forcibly exhaled in one second (FEV1), and Forced Vital Capacity (FVC) greater than 50% of predicted value (corrected for hemoglobin), or O2 saturation greater than 92% of room air An adequate autologous graft defined as a cryopreserved PBSC graft containing at least 4.0 x 106 CD34+ cells/kg patient weight; if prior to enrollment it is known that a patient will be on the auto-allo arm (i.e., a consenting, eligible HLA-matched sibling donor is available), the required autograft must contain at least 2.0 x 10^6 CD34+ cells/kg patient weight; the graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells; the graft can be collected at the transplanting institution or by a referring center; for patients without an HLA-matched sibling donor, the autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight Exclusion Criteria: Never advanced beyond Stage I MM since diagnosis Non-secretory MM (absence of a monoclonal protein [M protein] in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques) Plasma cell leukemia Karnofsky performance score less than 70%, unless approved by the Medical Monitor or one of the Protocol Chairs Uncontrolled hypertension Uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms) Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or one of the Protocol Chairs; cancer treated with curative intent more than 5 years previously will be allowed Pregnant or breastfeeding Seropositive for the human immunodeficiency virus (HIV) Unwilling to use contraceptive techniques during and for 12 months following treatment Prior allograft or prior autograft Received mid-intensity melphalan (more than 50 mg IV) as part of prior therapy Prior organ transplant requiring immunosuppressive therapy
Sites / Locations
- University of Alabama at Birmingham
- City of Hope Samaritan
- City of Hope National Medical Center
- Scripps Clinic/Green Hospital
- UCSD Medical Center
- Stanford Hospital and Clinics
- Colorado Blood Cancer Institute
- University of Florida College of Medicine (Shands)
- Emory University
- BMT Group of Georgia/Northside Hospital
- Loyola University
- IBMT (Indiana Blood and Marrow Transplant) at St Francis Franciscan Health
- Wichita CCOP
- Tufts - New England Medical Center
- DFCI/Brigham & Women's
- University of Michigan Medical Center
- University of Minnesota
- University of Nebraska Medical Center
- Hackensack University Medical Center
- Memorial Sloan-Kettering Cancer Center
- Duke University Medical Center
- Jewish Hospital BMT Program
- University Hospitals of Cleveland/Case Western
- University of Oklahoma Medical Center
- Oregon Health Sciences University (A)
- University of Pennsylvania Cancer Center
- Fox Chase - Temple University - BMT Program
- Vanderbilt University
- Baylor College of Medicine/The Methodist Hospital
- University of Texas/MD Anderson Cancer Research Center
- Texas Transplant Institute
- Utah BMT/Univ of Utah Med School
- Virginia Commonwealth University MCV Hospitals
- Fred Hutchinson Cancer Research Center
- University of Wisconsin Hospitals & Clinics
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Auto transplants plus Therapy
Auto transplants
Auto and Allo transplants
One autologous transplant along with a second autologous transplant will be preformed followed by one year of Dexamethasone and Thalidomide maintenance therapy.
One autologous transplant along with a second autologous transplant will be preformed followed by one year of observation.
One autologous transplant and one non-myeloablative allogeneic transplant will be preformed and followed by one year of observation.