autologous bone marrow transplantation (bmt) compared with allogeneic bmt in multiple myeloma

Conditions: Multiple Myeloma

Summary: a prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.


Eligibility criteria:
inclusion criteria: * age at diagnosis equal or under 55 year * 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 * 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 alt and ast less than 3 times the upper limit of normal * renal: creatinine clearance greater than 40 ml/min (measured or calculated/estimated) * pulmonary: dlco, fev1, and 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 10\^6 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

Keywords: mm