Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

Phase 2 Completed 40 enrolled Columbia University Cephalon · collab

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2013-01
Primary completion: 2019-03
Completion: 2019-07-03

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary objective was the rate of partial hematologic response (PR) or better. PMID 32083996 ↗

paper 57% of patients achieving a PR or better PMID 32083996 ↗

Publications

Lentzsch S, Lagos GG, Comenzo RL, Zonder JA, Osman K, Pan S, Bhutani D, Pregja S, Sanchorawala V, Landau H. Bendamustine With Dexamethasone in Relapsed/Refractory Systemic Light-Chain Amyloidosis: Results of a Phase II Study. J Clin Oncol. 2020 May 1;38(13):1455-1462. doi: 10.1200/JCO.19.01721. Epub 2020 Feb 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bendamustine	Small molecule	90 mg/m2	Intravenous
Subject	Bendamustine	Small molecule	100 mg/m2	Intravenous
Subject	Bendamustine	Small molecule	120 mg/m2	Intravenous
Subject	Dexamethasone	Small molecule	40 mg	Oral