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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00998270
First received: October 17, 2009
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Procedure: Autologous bone marrow transplantation
Procedure: Allogeneic bone marrow transplantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Autologous Bone Marrow Transplantation Compare With Allogeneic Bone Marrow Transplantation in Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Overall Survival and Progressive Free Survival in both two arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival and Progressive Free Survival in both two arms [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  • Treatment Related Mortality (TRM) in both two arms [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  • Acute and Chronic GVHD in Allogeneic arm [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 185
Study Start Date: October 2009
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Allogeneic

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998270

Contacts
Contact: Ardeshir Ghavamzadeh, MD 84902635 ext +98-21 ghavamza@sina.tums.ac.ir

Locations
Iran, Islamic Republic of
Hematology-Oncology & SCT Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Ardeshir Ghavamzadeh, MD    84902635 ext +98-21    ghavamza@sina.tums.ac.ir   
Principal Investigator: Ardeshir Ghavamzadeh, MD         
Sub-Investigator: Kamran Alimoghaddam, MD         
Sub-Investigator: Mahdi Jalili, MD         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Ardeshir Ghavamzadeh, MD Hematology-Oncology and SCT Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00998270     History of Changes
Other Study ID Numbers: HORCSCT-0901
Study First Received: October 17, 2009
Last Updated: May 31, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
MM

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014