NCT05250973 (AQUARIUS) is a Phase 2 clinical trial of Daratumumab in Amyloidosis, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT05250973?

NCT05250973 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT05250973?

Interventions in NCT05250973: Daratumumab, Cyclophosphamide, Bortezomib, Dexamethasone.

What condition does NCT05250973 study?

NCT05250973 studies Amyloidosis.

Is NCT05250973 still recruiting?

NCT05250973 is currently active, enrolled. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT05250973: AQUARIUS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

Active, enrolled Phase 2 Last updated 13 April 2026

What this trial tests

Phase 2 trial testing Daratumumab in Amyloidosis in 151 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 March 2022

Primary endpoint
30 May 2025

22 October 2026

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	151
Start date	1 March 2022
Primary completion	30 May 2025
Estimated completion	22 October 2026
Sites	46 locations across France, Italy, Netherlands, Greece, United Kingdom, Germany, Canada, China

Drugs / interventions tested

Daratumumab (daratumumab) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Bortezomib (bortezomib) — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

Amyloidosis — all drugs for Amyloidosis →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Amyloidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Predictors of treatment response and survival outcomes in patients with advanced cardiac AL amyloidosis.
Gustine JN, Staron A, Mendelson L, Joshi T, et al · · 2023 · cited 25× · PMID 37581513 · DOI 10.1182/bloodadvances.2023010324
Case Report: Avoiding misdiagnosis in amyloidosis-navigating transthyretin genopositivity and monoclonal gammopathy in a patient with advanced heart failure and spinal stenosis.
Wu X, Toskic D, Zhou P, Scalia S, et al · · 2024 · PMID 39736876 · DOI 10.3389/fcvm.2024.1479676
Defying the odds: 30 years in AL amyloidosis research-recent barriers to clinical trial enrollment.
Sanchorawala V, Barroso B, Shelton A, Goetz E, et al · · 2024 · PMID 39293090 · DOI 10.1182/bloodadvances.2024014262

Verify or expand the search:

Other trials of Daratumumab

Trials testing the same drug.

NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
NCT07393282 — A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) · Phase 3 · not yet recruiting
NCT07391657 — A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regi · Phase 3 · recruiting

Other recruiting trials for Amyloidosis

Currently open trials in the same condition.

NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT06974877 — Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using an Amyloid-Reactive Peptide to Measure · Phase 1 · recruiting
NCT07081646 — A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloido · Phase 1, PHASE2 · recruiting
NCT07232459 — [18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis · recruiting
NCT06573723 — Institutional Registry of Rare Diseases · recruiting

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05250973 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 13 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05250973.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing