Autologous Bone Marrow Transplantation (BMT) Compared With Allogeneic BMT in Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
MM
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Autologous bone marrow transplantation Type: Procedure
Name: Allogeneic bone marrow transplantation Type: Procedure
Overall Status
Recruiting
Summary
A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 55 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Hematology-Oncology & SCT Research Center
Tehran, Iran, Islamic Republic of
Status: Recruiting
Contact: Ardeshir Ghavamzadeh, MD - 84902635 - ghavamza@sina.tums.ac.ir
Start Date
October 2009
Completion Date
October 2017
Sponsors
Tehran University of Medical Sciences
Source
Tehran University of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page