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

Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma and Plasma Cell Neoplasm

Intervention: anti-thymocyte globulin (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center

Official(s) and/or principal investigator(s):
William I. Bensinger, MD, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center

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.

Clinical Details

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

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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:

Toxicity as assessed by NCI CTC v2.0

Formation of antirabbit antibodies

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: November 2005
Last updated: November 28, 2011

Page last updated: August 20, 2015

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