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

ConditionLight Chain (AL) Amyloidosis

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorNexcella Inc.

About this trial

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

Qualifiers

Eastern Cooperative Oncology Group performance status score ≤2

Newly diagnosed AL Amyloidosis per consensus criteria as defined in the protocol

Measurable disease as defined in the protocol

One or more organs impacted by AL amyloidosis

Disqualifiers

Prior therapy for AL amyloidosis or multiple myeloma

Diagnosis of multiple myeloma

Cardiac stage IIIb patients

History of malignancy (other than AL amyloidosis) within 3 years

Trial design

Treatments tested in this trial

NXC-201
Dara-CyBorD

Treatment groups

260 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Nexcella Inc.

Lead sponsor

Immix Biopharma, Inc.

Collaborator

Source ClinicalTrials.gov