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
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
ClinicalTrials.gov ID: NCT03201965
Sponsor: Janssen Research & Development, LLC
Information provided by: Janssen Research & Development, LLC (Responsible Party)
Last Update Posted: 2023-08-18
Brief 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.
Detailed Description:
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.
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
INTERVENTION / TREATMENT
Drug: Cyclophosphamide
Drug: Bortezomib
Drug: Dexamethasone, 40 mg
Drug: Daratumumab
| Category | Value |
|---|---|
| Study Start (Actual) | 2017-10-05 |
| Primary Completion (Actual) | 2020-02-14 |
| Study Completion (Estimated) | 2024-08-16 |
| Enrollment (Actual) | 416 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CR108193
2016-001737-27 (EudraCT Number) 54767414AMY3001 (Other Identifier) (OTHER: Janssen Research & Development, LLC) |