Status:
COMPLETED
Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
Phase:
PHASE2
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 wel...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00378768
Start Date
November 1 2005
End Date
June 1 2007
Last Update
November 30 2011
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024