Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

March 31, 2019

Study Completion Date

July 3, 2019

Conditions
AL Amyloidosis
Interventions
DRUG

Bendamustine

"Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle:~* CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle~* CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle~Available to qualifying subjects is the option to dose escalate to dose level (+)1:~* 120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study)~* 100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study)"

DRUG

Dexamethasone

40 mg orally on days 1, 8, 15, 22 of each cycle

Trial Locations (6)

10023

Mt. Sinai Medical Center, New York

10032

Columbia University, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

48201

Barbara Ann Karmanos Cancer Institute, Detroit

02111

Tufts Medical Center, Boston

02118

Boston Medical Center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cephalon

INDUSTRY

lead

Columbia University

OTHER