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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00378768
First Posted: September 21, 2006
Last Update Posted: November 30, 2011
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center
  Purpose

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:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378768


Locations
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)
Investigators
Principal Investigator: William I. Bensinger, MD Fred Hutchinson Cancer Research Center
  More Information

ClinicalTrials.gov Identifier: NCT00378768     History of Changes
Other Study ID Numbers: 2029.00
FHCRC-2029.00
GENZ-FHCRC-2029.00
CDR0000500474 ( Registry Identifier: PDQ )
First Submitted: September 19, 2006
First Posted: September 21, 2006
Last Update Posted: November 30, 2011
Last Verified: November 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
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents