Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
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.
Interventions
BIOLOGICALanti-thymocyte globulin
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Toxicity as assessed by NCI CTC v2.0 | — |
| Formation of antirabbit antibodies | — |
Countries
United States
Outcome results
None listed