NCT00790647

Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis

Phase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL Amyloidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib followed by stem cell transplant works in treating patients with primary systemic amyloidosis.

Detailed description

OBJECTIVES: * To determine if hematologic responses to high-dose melphalan and autologous stem cell transplantation increase with addition of bortezomib in the conditioning regimen in patients with primary systemic amyloidosis. OUTLINE: * Autologous stem cell mobilization and collection: Patients receive filgrastim to mobilize stem cells, which are then collected. * Conditioning regimen: Patients receive bortezomib intravenously on days -6, -3, 1, and 4 and oral high-dose melphalan on days -2 and -1. * Stem cell transplantation: Patients undergo autologous stem cell transplantation on day 0. After completion of study therapy, patients are followed every 6 months for 1 year and annually thereafter.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	16 mcg/kg daily beginning 3 days before stem cell collection through day before final stem cell collection
DRUG	bortezomib	1.0 mg/m2/dose D -6, D-3, D +1, D + 4
DRUG	melphalan	100 mg/m2/dose D -2, D -1
PROCEDURE	Stem Cell Infusion	infusion of previously collected autologous stem cells

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-12-01
• Completion: 2014-11-01
• First posted: 2008-11-13
• Last updated: 2017-02-06
• Results posted: 2017-02-06

Locations

1 site across 1 country: United States