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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center Identifier:
First received: September 19, 2006
Last updated: November 28, 2011
Last verified: November 2011

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.

Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm Biological: anti-thymocyte globulin Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant

Resource links provided by NLM:

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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:
  • Toxicity as assessed by NCI CTC v2.0
  • Formation of antirabbit antibodies

Estimated Enrollment: 12
Study Start Date: November 2005
Study Completion Date: June 2007
Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • More than 28 days since prior chemotherapy, including prednisone (20 mg equivalent/day)
  • No prior anti-thymocyte globulin
  • No concurrent radiotherapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00378768

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: William I. Bensinger, MD Fred Hutchinson Cancer Research Center
  More Information Identifier: NCT00378768     History of Changes
Other Study ID Numbers: 2029.00
CDR0000500474 ( Registry Identifier: PDQ )
Study First Received: September 19, 2006
Last Updated: November 28, 2011

Keywords provided by Fred Hutchinson Cancer Research Center:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents processed this record on August 21, 2017