Clinical trial · Interventional
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The VITAL study was terminated due to futility analysis
Summary
Brief summary (as posted)
This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Systemic (AL) Amyloidosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NEOD001 | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NEOD001
- description
- 24 mg/kg (maximum dose of 2500 mg) of NEOD001 administered once every 28 days.
- interventionNames
- Drug: NEOD001
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo will be administered as a 250 mL bag of normal saline once every 28 days.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Time to Composite of All-cause Mortality or Cardiac Hospitalization
- timeFrame
- Randomization until the date of death or cardiac hospitalization, up to 32 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Age ≥ 18 years 2. Newly diagnosed, AL amyloidosis treatment naïve 3. Bone marrow consistent with plasma cell dyscrasia 4. Confirmed diagnosis of AL amyloidosis 5. Cardiac involvement 6. Planned first-line chemotherapy contains a proteasome-inhibiting agent administered weekly 7. Adequate bone marrow reserve, hepatic and renal function Key Exclusion Criteria: 1. Non-AL amyloidosis 2. Meets diagnostic criteria for symptomatic multiple myeloma 3. Subject is eligible for and plans to undergo ASCT 4. History of Grade ≥ 3 infusion-associated AEs or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine or acetaminophen
References
Publications (1)
- DERIVEDGertz MA, Cohen AD, Comenzo RL, Kastritis E, Landau HJ, Libby EN, Liedtke M, Sanchorawala V, Schonland S, Wechalekar A, Zonder JA, Palladini G, Walling J, Guthrie S, Nie C, Karp C, Jin Y, Kinney GG, Merlini G. Birtamimab plus standard of care in light-chain amyloidosis: the phase 3 randomized placebo-controlled VITAL trial. Blood. 2023 Oct 5;142(14):1208-1218. doi: 10.1182/blood.2022019406. PMID 37366170