A 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 Amyloid Light-chain (AL) Amyloidosis

Official Title

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

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.

Trial Description

Primary Outcome Measures :

• Percentage of Participants With Overall Complete Hematologic Response

Secondary Outcome Measures :

• Major Organ Deterioration Progression-Free Survival (MOD-PFS)
• Progression-Free Survival (PFS)
• Organ Response Rate (OrRR)
• Overall Survival (OS)
• Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Fatigue Scale Score
• Change From Baseline in the 36-Item Short Form Survey version 2 (SF-36v2) Mental Component Summary (MCS)
• Change From Baseline in the EORTC QLQ-C30 Global Health Status Scale Score
• Time to Next Treatment (TNT)
• Hematologic Very Good Partial Response or Better Rate
• Time to Complete Hematologic Response
• Time to Hematologic Very Good Partial Response (VGPR) or Better Response
• Duration of Complete Hematologic Response
• Duration of Hematologic Very Good Partial Response (VGPR) or Better Response
• Time to Organ Response
• Duration of Organ Response
• Participant involved in study for approx. 8 years duration includes Screening Phase (complete clinical evaluation will be done), Treatment Phase (monitoring of adverse events (AEs), laboratory abnormalities and clinical response), Post-Treatment Observation Phase (disease evaluations will be done) and a Long-term Follow-up Phase (Subsequent anticancer treatment, response to subsequent treatment, date of progression and survival status will be obtained every 16 weeks).The primary hypothesis is that daratumumab in combination with CyBorD will improve the overall complete hematological response rate compared to CyBorD alone in AL amyloidosis participants. Safety will be assessed by AEs, laboratory test results, electrocardiogram, vital sign measurements, physical examination, and Eastern Cooperative Oncology Group (ECOG) performance status.

View this trial on ClinicalTrials.gov