NCT00802568

Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment

Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with multiple myeloma that has not responded to treatment.

Detailed description

OBJECTIVES: Primary * To study the toxicity of reduced intensity conditioning comprising fludarabine phosphate, busulfan, and anti-thymocyte globulin followed by allogeneic hematopoietic stem cell transplantation in patients with refractory or relapsed multiple myeloma. Secondary * To study the tumor response in these patients. * To study the incidence of acute or chronic graft-versus-host disease in these patients. * To study the incidence of infectious complications in these patients. * To study relapse- or progression-free and overall survival of these patients. * To study the biological mechanisms (i.e., taking graft, immunological recovery, antitumor activity, and chimerism). OUTLINE: This is a multicenter study. Patients receive reduced intensity conditioning comprising fludarabine IV on days -5 to -1, oral busulfan on days -4 and -3, and anti-thymocyte globulin IV on days -2 and -1. Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. After completion of study therapy, patients are followed every month for 6 months and then every 3 months for 1½ years.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin
DRUG	busulfan
DRUG	fludarabine phosphate
PROCEDURE	allogeneic bone marrow transplantation
PROCEDURE	nonmyeloablative allogeneic hematopoietic stem cell transplantation

Timeline

• Start date: 2007-04-01
• Primary completion: 2011-05-01
• First posted: 2008-12-05
• Last updated: 2011-05-16

Locations

1 site across 1 country: France