Multiple Myeloma
Conditions
Keywords
MM
Brief summary
A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.
Interventions
PROCEDUREAutologous bone marrow transplantation
Autologous transplantation: * Endoxan (for mobilization) Dose: 2.5 g/m2 IV Time: -11 Duration: 1 day * G-CSF (Neupogen) Dose: 0.5 micg/kg subcutaneous Time: -6 to -3 Duration: 4 days * Melphalan Dose: 100 mg/m2 IV Time: -2 and -1 Duration: 2 days
PROCEDUREAllogeneic bone marrow transplantation
Allogeneic * Melphalan Dose: 70 mg/m2 IV Time: Duration: 2 days * Fludarabine Dose: 30 mg/m2 IV Time: Duration: 5 days
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival and Progressive Free Survival in both two arms | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Acute and Chronic GVHD in Allogeneic arm | 3 year |
| Overall Survival and Progressive Free Survival in both two arms | 3 year |
| Treatment Related Mortality (TRM) in both two arms | 3 year |
Countries
Iran
Contacts
Primary ContactArdeshir Ghavamzadeh, MD
Outcome results
None listed