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

NCT00998270 | Unknown Phase 2 DMC

• 1 other identifier: HORCSCT-0901
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

MM

Outcome Measures

Primary Outcomes (1)

• Overall Survival and Progressive Free Survival in both two arms

  1 year

Secondary Outcomes (3)

• 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

Study Arms (2)

Autologous arm

ACTIVE COMPARATOR

Procedure: Autologous bone marrow transplantation

Allogeneic arm

EXPERIMENTAL

Procedure: Allogeneic bone marrow transplantation

Interventions

Autologous bone marrow transplantation 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

Also known as: Autologous

Autologous arm

Allogeneic bone marrow transplantation PROCEDURE

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

Also known as: Allogeneic

Allogeneic arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ardeshir Ghavamzadeh, MD

  Hematology-Oncology and SCT Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ardeshir Ghavamzadeh, MD

CONTACT

84902635; ghavamza@sina.tums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2009
• First Posted: October 20, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2017
• Last Updated: June 4, 2012

Record last verified: 2012-05

Locations

IR (1)