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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00998270
• Other study ID #: HORCSCT-0901
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 17, 2009
• Last updated: May 31, 2012
• Start date: October 2009
• Est. completion date: October 2017

Study information

• Verified date: May 2012
• Source: Tehran University of Medical Sciences
• Contact: Ardeshir Ghavamzadeh, MD
• Phone: 84902635
• Email: ghavamza[@]sina.tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: October 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hematology-Oncology & SCT Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival and Progressive Free Survival in both two arms		1 year	No
Secondary	Overall Survival and Progressive Free Survival in both two arms		3 year	No
Secondary	Treatment Related Mortality (TRM) in both two arms		3 year	No
Secondary	Acute and Chronic GVHD in Allogeneic arm		3 year	No

External Links

•   Hematology-Oncology and Stem Cell Transplantation Research Center