Clinical Trial: Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

Brief Summary: The study is being done to see if the combination of bendamustine and dexamethasone will help people with amyloidosis that has returned after standard treatment, and to to estimate the partial hematologic response rate (PHR).

Detailed Summary:

Systemic light-chain amyloidosis (AL) is a protein conformation disorder due to a clonal plasma cell dyscrasia. There are no established and approved second-line therapies for patients with systemic AL amyloidosis who fail initial melphalan-based treatment, be it high-dose melphalan with stem cell transplant or oral melphalan and dexamethasone (MDex). Therefore new treatments are needed for those who fail initial therapy and for those who initially respond but subsequently relapse.

Therapy of AL is generally based on treatment regimens used in multiple myeloma (MM). Bendamustine achieves partial response with relapsed/refractory MM. Based on this high anti-MM activity, we anticipate that bendamustine will also be very active in clonal plasma cell disorder associated with AL.


Sponsor: Columbia University

Current Primary Outcome: Partial hematologic response rate [ Time Frame: Up to 2 years ]

Original Primary Outcome: Determine the complete hematologic response (CHR). [ Time Frame: 2 years ]

Current Secondary Outcome:

  • Overall hematologic response rate [ Time Frame: Up to 2 years ]
  • Organ response rate [ Time Frame: Up to 2 years ]
  • Time to Treatment Failure [ Time Frame: Up to 2 years ]


Original Secondary Outcome:

  • Determine overall hematologic response (OHR) rate [ Time Frame: 2 years ]
  • Determine the organ response rate (OrRR) [ Time Frame: 2 years ]
  • Determine TTF [ Time Frame: 2 years ]


Information By: Columbia University

Dates:
Date Received: October 14, 2010
Date Started: June 2012
Date Completion: December 2021
Last Updated: January 14, 2017
Last Verified: January 2017