Back to resultsAntithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
Primary Purpose
Multiple Myeloma and Plasma Cell Neoplasm
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed multiple myeloma
- Candidate for autologous or allogeneic stem cell transplantation within 1 to 3 months after study treatment
- Measurable disease, defined as serum monoclonal protein ≥ 1 g/dL OR urinary light chain excretion = 500 mg/24 hours
- No malignant CNS disease
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 6 months
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count > 50,000/mm³
- Creatinine ≤ 2 mg/dL
- Hepatic function ≤ 2 times upper limit of normal
- DLCO ≥ 50%
- No active infection
- No hypersensitivity to rabbit proteins
- No symptomatic hyperviscosity syndrome
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- More than 28 days since prior chemotherapy, including prednisone (20 mg equivalent/day)
- No prior anti-thymocyte globulin
- No concurrent radiotherapy
Sites / Locations
- Fred Hutchinson Cancer Research Center
Outcomes
Primary Outcome Measures
Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks
Secondary Outcome Measures
Toxicity as assessed by NCI CTC v2.0
Formation of antirabbit antibodies
Full Information
NCT ID
NCT00378768
First Posted
September 19, 2006
Last Updated
November 28, 2011
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00378768
Brief Title
Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
Official Title
A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
OBJECTIVES:
Primary
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.
Secondary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
anti-thymocyte globulin
Primary Outcome Measure Information:
Title
Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks
Secondary Outcome Measure Information:
Title
Toxicity as assessed by NCI CTC v2.0
Title
Formation of antirabbit antibodies
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed multiple myeloma
Candidate for autologous or allogeneic stem cell transplantation within 1 to 3 months after study treatment
Measurable disease, defined as serum monoclonal protein ≥ 1 g/dL OR urinary light chain excretion = 500 mg/24 hours
No malignant CNS disease
PATIENT CHARACTERISTICS:
Life expectancy ≥ 6 months
Absolute neutrophil count ≥ 1,000/mm³
Platelet count > 50,000/mm³
Creatinine ≤ 2 mg/dL
Hepatic function ≤ 2 times upper limit of normal
DLCO ≥ 50%
No active infection
No hypersensitivity to rabbit proteins
No symptomatic hyperviscosity syndrome
Negative pregnancy test
PRIOR CONCURRENT THERAPY:
More than 28 days since prior chemotherapy, including prednisone (20 mg equivalent/day)
No prior anti-thymocyte globulin
No concurrent radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William I. Bensinger, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
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