At a glance
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A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis
In Brief
A Phase 3 clinical trial evaluating Cyclophosphamide, Bortezomib, and 2 other interventions for Amyloidosis. Completed, enrolled 416 participants across 140 sites in 22 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Study Details
Timeline
Interventions
Participants will receive 300 mg/m\^2 of cyclophosphamide as an oral or IV dose.
Participants will receive 1.3 mg/m\^2 of bortezomib as an subcutaneous (SC) injection.
Participants of CyBorD alone arm will receive 40 mg dexamethasone orally or IV dose. Participants of CyBorD plus daratumumab arm will receive dexamethasone 20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing to make a total of 40 mg.
Participants will receive 1800 mg of daratumumab subcutaneously.