Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
|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|
U.S. FDA Resources
- 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
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|