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

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

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

Study Overview

• Status: Unknown
• Conditions: Multiple Myeloma
• Intervention / Treatment: Procedure: Autologous bone marrow transplantation; Procedure: Allogeneic bone marrow transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 185
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Hematology-Oncology & SCT Research Center
    • Principal Investigator: Ardeshir Ghavamzadeh, MD
    • Sub-Investigator: Kamran Alimoghaddam, MD
    • Sub-Investigator: Mahdi Jalili, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Autologous
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: Allogeneic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Principal Investigator: Ardeshir Ghavamzadeh, MD, Hematology-Oncology and SCT Research Center

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ANTICIPATED): October 1, 2014
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: October 17, 2009
• First Submitted That Met QC Criteria: October 19, 2009
• First Posted (ESTIMATE): October 20, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 4, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: MM
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: HORCSCT-0901