Autologous Bone Marrow Transplantation (BMT) Compared With Allogeneic BMT in Multiple Myeloma

Study Overview
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Brief Summary
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A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.

Official Title
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A Prospective, Randomized Trial of Autologous Bone Marrow Transplantation Compare With Allogeneic Bone Marrow Transplantation in Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Procedure: Autologous bone marrow transplantation
* Procedure: Allogeneic bone marrow transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autologous arm<br> | Procedure: Autologous bone marrow transplantation<br>* 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<br>* Other names: Autologous;|
| Experimental: Allogeneic arm<br> | Procedure: Allogeneic bone marrow transplantation<br>* Allogeneic Melphalan Dose: 70 mg/m2 IV Time: Duration: 2 days Fludarabine Dose: 30 mg/m2 IV Time: Duration: 5 days<br>* Other names: Allogeneic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival and Progressive Free Survival in both two arms |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival and Progressive Free Survival in both two arms |  | 3 year | 
| Treatment Related Mortality (TRM) in both two arms |  | 3 year | 
| Acute and Chronic GVHD in Allogeneic arm |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MM