Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00802568|
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : May 16, 2011
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with multiple myeloma that has not responded to treatment.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: anti-thymocyte globulin Drug: busulfan Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation||Phase 2|
- To study the toxicity of reduced intensity conditioning comprising fludarabine phosphate, busulfan, and anti-thymocyte globulin followed by allogeneic hematopoietic stem cell transplantation in patients with refractory or relapsed multiple myeloma.
- To study the tumor response in these patients.
- To study the incidence of acute or chronic graft-versus-host disease in these patients.
- To study the incidence of infectious complications in these patients.
- To study relapse- or progression-free and overall survival of these patients.
- To study the biological mechanisms (i.e., taking graft, immunological recovery, antitumor activity, and chimerism).
OUTLINE: This is a multicenter study.
Patients receive reduced intensity conditioning comprising fludarabine IV on days -5 to -1, oral busulfan on days -4 and -3, and anti-thymocyte globulin IV on days -2 and -1. Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
After completion of study therapy, patients are followed every month for 6 months and then every 3 months for 1½ years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||May 2011|
- Mortality rate at 1 year
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): NCT00802568
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|OverallOfficial:||Didier Blaise, MD||Institut Paoli-Calmettes|