Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00378768|
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : November 30, 2011
RATIONALE: Biological therapies, such as antithymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase II trial is studying how well antithymocyte globulin works in treating patients undergoing stem cell transplant for multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: anti-thymocyte globulin||Phase 2|
- Determine the response rate at 4 weeks in patients with multiple myeloma treated with anti-thymocyte globulin at least 4 to 6 weeks prior to undergoing conditioning therapy for allogeneic or autologous stem cell transplantation.
- Determine the toxicity of this drug, in terms of formation of antirabbit antibodies, in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive anti-thymocyte globulin IV over 6 hours on day 1 and over 4 hours on days 3 and 5. Treatment begins 4 to 6 weeks prior to undergoing conditioning therapy for autologous or allogeneic stem cell transplantation.
After completion of study treatment, patients are followed at 28 days.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant|
|Study Start Date :||November 2005|
|Actual Study Completion Date :||June 2007|
- Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks
- Toxicity as assessed by NCI CTC v2.0
- Formation of antirabbit antibodies
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): NCT00378768
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Principal Investigator:||William I. Bensinger, MD||Fred Hutchinson Cancer Research Center|