Participant flow

Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis · Source last updated 2020-03-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Subjects with relapsed/refractory systemic light-chain (AL) will receive Bendamustine and Dexamethasone. Bendamustine: Patients will start bendamustine at dose level 0 and according to creatinine clearance (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) Dexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle

   id

   FG000

   title

   Treatment Arm

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         31

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         29

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Between January 2013 and March 2016, 40 patients were enrolled in the study and 31 patients were treated.

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Preserved source evidence · Not medical advice