Autologous Bone Marrow Transplantation (BMT) Compared With Allogeneic BMT in Multiple Myeloma
Study Details
Study Description
Brief Summary
A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Autologous arm
|
Procedure: Autologous 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
Other Names:
|
| Experimental: Allogeneic arm
|
Procedure: Allogeneic bone marrow transplantation
Allogeneic
Melphalan Dose: 70 mg/m2 IV Time: Duration: 2 days
Fludarabine Dose: 30 mg/m2 IV Time: Duration: 5 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival and Progressive Free Survival in both two arms [1 year]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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 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 106 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hematology-Oncology & SCT Research Center | Tehran | Iran, Islamic Republic of |
Sponsors and Collaborators
- Tehran University of Medical Sciences
Investigators
- Principal Investigator: Ardeshir Ghavamzadeh, MD, Hematology-Oncology and SCT Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HORCSCT-0901