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

This study is currently recruiting participants.
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

October 17, 2009
May 31, 2012
October 2009
October 2014   (final data collection date for primary outcome measure)
Overall Survival and Progressive Free Survival in both two arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998270 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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
  • 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
  • Active Comparator: Autologous arm
    Intervention: Procedure: Autologous bone marrow transplantation
  • Experimental: Allogeneic arm
    Intervention: Procedure: Allogeneic bone marrow transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
185
October 2017
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact: Ardeshir Ghavamzadeh, MD 84902635 ext +98-21 ghavamza@sina.tums.ac.ir
Iran, Islamic Republic of
 
NCT00998270
HORCSCT-0901
Yes
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Ardeshir Ghavamzadeh, MD Hematology-Oncology and SCT Research Center
Tehran University of Medical Sciences
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP