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OpenTrials
Completed

NCT Number: NCT00378768

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti-thymocyte globulin

Biological

Primary outcomes

  1. 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 outcomes

  1. Toxicity as assessed by NCI CTC v2.0

  2. Formation of antirabbit antibodies

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Sep 21, 2006
Registry last updated
Nov 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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