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

NCT ID: NCT00998270

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2017-10-31

Brief Summary

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

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous arm

Group Type: ACTIVE_COMPARATOR

Autologous bone marrow transplantation

Intervention Type: PROCEDURE

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

Allogeneic arm

Group Type: EXPERIMENTAL

Allogeneic bone marrow transplantation

Intervention Type: PROCEDURE

Allogeneic

• Melphalan Dose: 70 mg/m2 IV Time: Duration: 2 days
• Fludarabine Dose: 30 mg/m2 IV Time: Duration: 5 days

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

Autologous; Allogeneic

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ardeshir Ghavamzadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Hematology-Oncology and SCT Research Center

Locations

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Ardeshir Ghavamzadeh, MD

Role: CONTACT

ghavamza@sina.tums.ac.ir

84902635 ext. +98-21

Facility Contacts

Ardeshir Ghavamzadeh, MD

Role: primary

ghavamza@sina.tums.ac.ir

84902635 ext. +98-21

Other Identifiers

HORCSCT-0901

Identifier Type: -

Identifier Source: org_study_id