Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant

Conditions
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Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Biological: anti-thymocyte globulin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: anti-thymocyte globulin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as assessed by NCI CTC v2.0 |  |  | 
| Formation of antirabbit antibodies |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma