NCT01453101

Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma

A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and bortezomib improves the progression free survival and the response rate compared to historical controls of fludarabine and melphalan alone.

Detailed description

Multiple myeloma is the second most prevalent blood cancer (10%) after non-hodgkin's lymphoma. It represents approximately 1% of all cancers and 2% of all cancer deaths. Although the peak age of onset of multiple myeloma is 70 years of age, recent statistics indicate both increasing incidence and earlier age of onset. The historical control 2-year progression-free survival (PFS) is assumed to be 35%. The proposed therapy of fludarabine, melphalan and bortezomib is expected to improve the PFS by 20%.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Fludarabine monophosphate, melphalan, Bortezomib	* Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5. * Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2 * Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.

Timeline

• Start date: 2010-06-09
• Primary completion: 2020-06-11
• Completion: 2020-06-11
• First posted: 2011-10-17
• Last updated: 2026-04-08
• Results posted: 2022-05-25

Locations

1 site across 1 country: United States