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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00378768
First received: September 19, 2006
Last updated: November 28, 2011
Last verified: November 2011

September 19, 2006
November 28, 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 [ Designated as safety issue: No ]
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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 [ Designated as safety issue: Yes ]
  • Formation of antirabbit antibodies [ Designated as safety issue: No ]
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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.

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.

Interventional
Phase 2
Masking: 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.
 
Completed
12
June 2007
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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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00378768
2029.00, FHCRC-2029.00, GENZ-FHCRC-2029.00, CDR0000500474
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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