Clinical Trial: Trial of HDM/SCT Versus HDM + Bortezomib/SCT in AL Amyloidosis

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


Sponsor: Boston Medical Center

Current Primary Outcome: analysis of number of participants with hematologic response [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • analysis of number and severity of toxicities using the National Cancer Institute Common Terminology Criteria for Adverse Events scale [ Time Frame: 100 days ]
  • analysis of duration of overall survival [ Time Frame: 5 years ]
  • analysis of number of patients with organ response [ Time Frame: 5 years ]


Original Secondary Outcome: Same as current

Information By: Boston Medical Center

Dates:
Date Received: March 9, 2015
Date Started: June 2015
Date Completion: May 2040
Last Updated: June 6, 2016
Last Verified: June 2016