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Tracking Information | |||||
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First Received Date ICMJE | December 4, 2008 | ||||
Last Updated Date | May 1, 2009 | ||||
Start Date ICMJE | April 2007 | ||||
Current Primary Outcome Measures ICMJE |
Mortality rate at 1 year [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00802568 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment | ||||
Official Title ICMJE | Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma | ||||
Brief Summary | 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. |
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Detailed Description | 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
After completion of study therapy, patients are followed every month for 6 months and then every 3 months for 1½ years. |
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Study Phase | Phase II | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Non-Randomized, Open Label | ||||
Condition ICMJE | Multiple Myeloma and Plasma Cell Neoplasm | ||||
Intervention ICMJE |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 48 | ||||
Completion Date | |||||
Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | France | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00802568 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | CDR0000626720, IPC-2005-002, IPC-ITT 04-02, EUDRACT-2005-01053-13, INCA-RECF0428, AMGEN-IPC-2005-002, JANSSEN-IPC-2005-002 | ||||
Study Sponsor ICMJE | Institut Paoli-Calmettes | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | December 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |