Linvoseltamab Versus Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Adult Participants With Newly Diagnosed Systemic Light Chain Amyloidosis
Run by Regeneron Pharmaceuticals · NCT07901725 · Data updated 2026-11-12
Not yet open. This study is not taking new participants. Its registered completion date is 2035-07-25.
This study is researching a Regeneron drug called linvoseltamab ("study drug") alone compared to standard of care (SoC) combination to see if it can help treat participants who are newly diagnosed and previously untreated for systemic amyloid light-chain (AL) amyloidosis. The aim of this study is to see if the safety and efficacy of linvoseltamab alone can deliver better disease control and outcomes than Dara-VCd. The study is looking at: * What side effects linvoseltamab alone might cause * How well linvoseltamab works compared to Dara-VCd regimen in terms of reductions of the abnormal pro…
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 382 (estimated) |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | Linvoseltamab, Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone |
| Trial ID | NCT07901725 on ClinicalTrials.gov |
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Confirmed diagnosis of AL amyloidosis as documented historically, as described in the protocol 2. Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC), as described in the protocol 3. Adequate hematologic, renal, and hepatic function, as described in the protocol 4. Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening Key Exclusion Criteria: 1. History of other non-AL amyloidosis 2. Greater than or equal to 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening 3. Presence of lytic bone lesion(s) or plasmacytoma (extramedullary or paraskeletal) on imaging during screening 4. Left ventricular ejection fraction \<40% by echocardiogram during screening, congestive heart failure and acute coronary syndrome or myocardial infarction within 6 months of screening 5. Prior AL amyloidosis treatment Note: Other protocol-defined Inclusion/Exclusion criteria apply
Study contacts
- Principal investigator: Clinical Trial Management — Regeneron Pharmaceuticals
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.