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Trial intelligence / Profile preview
Bendamustine and Dexamethasone in Relapsed AL Amyloidosis
NCT01222260Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2013
- Primary completion
- Mar 2019
- Countries
- 1
- Sponsor
- Columbia University
- Modality
- Small Molecules
- Drugs
- bendamustine
- Conditions
- amyloid light chain amyloidosis
01
Overview
Phase 2, open-label, single-arm trial of bendamustine in amyloid light chain amyloidosis, sponsored by Columbia University. Primary endpoint: Partial Hematologic Response Rate up to 2 years. Started Jan 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment Arm
Subjects with AL will receive Bendamustine and Dexamethasone
03
Who it enrols
Patients with relapsed AL amyloidosis who have received at least one prior therapy, with adequate organ function and no symptomatic multiple myeloma or severe heart failure.
04
Endpoints
Primary
Partial Hematologic Response Rate
Secondary
Overall Hematologic Response Rate
Organ Response Rate
Median Overall Survival
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