NCT00054353

Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma

Reduced-Intensity Allogeneic HSC Transplantation From HLA-Matched Related and Unrelated Donors for Patients With Multiple Myeloma - A Multi-Center Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT helps stop the growth of cancer cells. It may also stop 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). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of this approach by determining the 1-year progression-free survival (PFS) and overall survival (OS). II. To evaluate day 100 non-relapse mortality. III. To determine the incidences of grades II-IV acute graft-versus-host disease (GVHD) and chronic extensive GVHD. OUTLINE: PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or thrice daily (TID) on days 0-40 with taper to day 96 (unrelated donors). After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months, and then annually thereafter for 5 years.

Conditions

• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	fludarabine phosphate	Given IV
DRUG	melphalan	Given IV
RADIATION	total-body irradiation	Undergo TBI
DRUG	mycophenolate mofetil	Given PO
DRUG	cyclosporine	Given PO
PROCEDURE	nonmyeloablative allogeneic hematopoietic stem cell transplantation	Undergo reduced-intensity allogeneic PBSCT
PROCEDURE	peripheral blood stem cell transplantation	Undergo reduced-intensity allogeneic PBSCT
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-10-01
• Primary completion: 2009-10-01
• Completion: 2012-10-14
• First posted: 2003-02-06
• Last updated: 2017-10-16
• Results posted: 2017-10-16

Locations

2 sites across 2 countries: United States, Italy