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Sponsored by: |
Institut Paoli-Calmettes |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00802568 |
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 | Intervention | 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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma |
Estimated Enrollment: | 48 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma, meeting 1 of the following criteria:
Stage II or III disease meeting any of the following criteria:
HLA identical family donor available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
France | |
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | |
Marseille, France, 13273 |
Investigator: | Didier Blaise, MD | Institut Paoli-Calmettes |
Study ID Numbers: | CDR0000626720, IPC-2005-002, IPC-ITT 04-02, EUDRACT-2005-01053-13, INCA-RECF0428, AMGEN-IPC-2005-002, JANSSEN-IPC-2005-002 |
Study First Received: | December 4, 2008 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00802568 History of Changes |
Health Authority: | United States: Federal Government |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma osteolytic lesions of multiple myeloma |
Antimetabolites Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Fludarabine monophosphate Hemostatic Disorders |
Immunosuppressive Agents Multiple Myeloma Antilymphocyte Serum Hemorrhagic Disorders Busulfan Antineoplastic Agents, Alkylating Fludarabine Lymphoproliferative Disorders Alkylating Agents Neoplasms, Plasma Cell |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Hematologic Diseases Vascular Diseases Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Antilymphocyte Serum Neoplasms Busulfan Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Neoplasms, Plasma Cell |