NCT07901725Not yet recruitingPhase 3
Linvoseltamab Versus Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Adult Participants With Newly Diagnosed Systemic Light Chain Amyloidosis
An Open-Label, Randomized Phase 3 Trial of Linvoseltamab Compared With Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Participants With Newly Diagnosed Systemic Light Chain Amyloidosis
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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 proteins that cause AL-amyloidosis that affects the heart and kidney functions and for how long * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 382 (estimated)
- First submitted
- 22 Oct 2026
- Start date
- 18 Dec 2026
- Primary completion date
- 25 Jul 2035
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Amyloidosis
- NCT number
- NCT07901725
- EU CT number
- 2026-526156-32-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 382
- From 18 Dec 2026 to the primary completion date, 25 Jul 2035
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior AL amyloidosis treatment
- Note: Other protocol-defined Inclusion/Exclusion criteria apply
Other illness
- History of other non-AL amyloidosis
Lab values
- Left ventricular ejection fraction \<40% by echocardiogram during screening, congestive heart failure and acute coronary syndrome or myocardial infarction within 6 months of screening
Other
- Greater than or equal to 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening
- Presence of lytic bone lesion(s) or plasmacytoma (extramedullary or paraskeletal) on imaging during screening
Who the study is looking for
- Confirmed diagnosis of AL amyloidosis as documented historically, as described in the protocol
- Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC), as described in the protocol
- Adequate hematologic, renal, and hepatic function, as described in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.