NCT02489500

Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant. This study will compare the safety and effectiveness of standard treatment with high-dose melphalan and stem cell transplant, compared with investigational bortezomib when used in combination with standard treatment with high-dose melphalan and stem cell transplant for AL amyloidosis.

Detailed description

This study seeks to enroll patients with AL amyloidosis who have been recommended for standard treatment with high-dose melphalan and stem cell transplant. Standard treatment for this disease is high-dose melphalan and stem cell transplant. The purpose of this study is to compare the safety and effectiveness of standard treatment with high-dose melphalan and stem cell transplant, compared with investigational bortezomib when used in combination with standard treatment with high-dose melphalan and stem cell transplant for AL amyloidosis. Patients enrolled in this study will receive either standard treatment with high-dose melphalan and stem cell transplant, or investigational bortezomib used in combination with standard treatment with high-dose melphalan and stem cell transplant.

Conditions

• AL Amyloidosis

Interventions

Type	Name	Description
DRUG	Bortezomib	Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1
DRUG	Melphalan	Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0
DRUG	Neupogen	granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days
PROCEDURE	Stem Cell Collection	collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells
PROCEDURE	Stem cell infusion	infusion of previously collected autologous stem cells

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-04-28
• Completion: 2017-04-28
• First posted: 2015-07-03
• Last updated: 2018-09-10
• Results posted: 2018-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study