NCT00378768

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin

Timeline

• Start date: 2005-11-01
• Completion: 2007-06-01
• First posted: 2006-09-21
• Last updated: 2011-11-30

Locations

1 site across 1 country: United States