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NCT07709715
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis
Conditions: Light Chain (AL) Amyloidosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 260
Sponsor: Nexcella Inc.
Summary
The purpose of this study is to evaluate the efficacy and safety of NXC-201 compared with Dara-CyBorD (daratumumab-cyclophosphamide-bortezomib-dexamethasone) in the treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Eligibility Criteria
Key Inclusion Criteria:
1. Eastern Cooperative Oncology Group performance status score ≤2
2. Newly diagnosed AL Amyloidosis per consensus criteria as defined in the protocol
3. Measurable disease as defined in the protocol
4. One or more organs impacted by AL amyloidosis
Key Exclusion Criteria:
1. Prior therapy for AL amyloidosis or multiple myeloma
2. Diagnosis of multiple myeloma
3. Cardiac stage IIIb patients
4. History of malignancy (other than AL amyloidosis) within 3 years
5. Stroke or seizure within 6 months of signing ICF
NOTE: Other protocol defined inclusion/exclusion criteria apply
Source: ClinicalTrials.gov (NCT07709715). StuddyBuddy aggregates publicly available trial information.
