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

Fred Hutchinson Cancer Center12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Interventions

anti-thymocyte globulinBIOLOGICAL

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

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 Outcomes

Toxicity as assessed by NCI CTC v2.0

Formation of antirabbit antibodies

Data from ClinicalTrials.gov

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