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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00378768
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : November 30, 2011
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

September 19, 2006
September 21, 2006
November 30, 2011
November 2005
Not Provided
Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks
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Complete list of historical versions of study NCT00378768 on ClinicalTrials.gov Archive Site
  • Toxicity as assessed by NCI CTC v2.0
  • Formation of antirabbit antibodies
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Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant

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.



  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
Biological: anti-thymocyte globulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2007
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  • 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
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000500474 ( Registry Identifier: PDQ )
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Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: William I. Bensinger, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP