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

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ClinicalTrials.gov Identifier: NCT00998270
Recruitment Status : Unknown
Verified May 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 20, 2009
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Procedure: Autologous bone marrow transplantation Procedure: Allogeneic bone marrow transplantation Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2009
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2017


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 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



Primary Outcome Measures :
  1. Overall Survival and Progressive Free Survival in both two arms [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall Survival and Progressive Free Survival in both two arms [ Time Frame: 3 year ]
  2. Treatment Related Mortality (TRM) in both two arms [ Time Frame: 3 year ]
  3. Acute and Chronic GVHD in Allogeneic arm [ Time Frame: 3 year ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00998270     History of Changes
Other Study ID Numbers: HORCSCT-0901
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: May 2012

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