Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
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.
Multiple Myeloma and Plasma Cell Neoplasm
Biological: anti-thymocyte globulin
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant|
- Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTC v2.0 [ Designated as safety issue: Yes ]
- Formation of antirabbit antibodies [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||June 2007|
- 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.
|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|