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NCT04131309
A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis
Completed
Phase 2
Last updated 16 April 2025
What this trial tests
Phase 2 trial testing Daratumumab in Light Chain (AL) Amyloidosis, Stage 3B in 40 participants. Completed in 27 January 2025.
Timeline
23 September 2019
Primary endpoint
27 January 2025
27 January 2025
27 January 2025
Quick facts
| Lead sponsor | Stichting European Myeloma Network |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 23 September 2019 |
| Primary completion | 27 January 2025 |
| Estimated completion | 27 January 2025 |
| Sites | 5 locations across France, Netherlands, Greece, Italy |
Drugs / interventions tested
- Daratumumab (daratumumab) — full drug profile →
- Bortezomib Injection — full drug profile →
- Dexamethasone oral tablet
Conditions studied
- Light Chain (AL) Amyloidosis, Stage 3B — all drugs for Light Chain (AL) Amyloidosis, Stage 3B →
Sponsor
Stichting European Myeloma Network
Who can join
18 and older, any sex, with Light Chain (AL) Amyloidosis, Stage 3B. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed stage 3B light chain (AL) amyloidosis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic Opportunities with Pharmacological Inhibition of CD38 with Isatuximab.
Martin TG, Corzo K, Chiron M, Velde HV, et al · · 2019 · cited 103× · PMID 31779273 · DOI 10.3390/cells8121522 -
Systemic AL Amyloidosis: Current Approaches to Diagnosis and Management.
Fotiou D, Dimopoulos MA, Kastritis E. · · 2020 · cited 34× · PMID 32885146 · DOI 10.1097/hs9.0000000000000454 -
Management of AL amyloidosis in 2020.
Palladini G, Milani P, Merlini G. · · 2020 · cited 29× · PMID 33275753 · DOI 10.1182/hematology.2020006913 -
Daratumumab in the Treatment of Light-Chain (AL) Amyloidosis.
Palladini G, Milani P, Malavasi F, Merlini G. · · 2021 · cited 27× · PMID 33806310 · DOI 10.3390/cells10030545 -
Outcomes by Cardiac Stage in Patients With Newly Diagnosed AL Amyloidosis: Phase 3 ANDROMEDA Trial.
Minnema MC, Dispenzieri A, Merlini G, Comenzo RL, et al · · 2022 · cited 16× · PMID 36444227 · DOI 10.1016/j.jaccao.2022.08.011 -
Current Therapies and Future Horizons in Cardiac Amyloidosis Treatment.
Vogel J, Carpinteiro A, Luedike P, Buehning F, et al · · 2024 · cited 13× · PMID 38809394 · DOI 10.1007/s11897-024-00669-7 -
Pulmonary AL amyloidosis: A review and update on treatment options.
Moy LN, Mirza M, Moskal B, Asado N, et al · · 2022 · cited 9× · PMID 35855884 · DOI 10.1016/j.amsu.2022.104060 -
Recent advances in the diagnosis and management of amyloid cardiomyopathy.
Nijst P, Tang WW. · · 2021 · cited 7× · PMID 33817700 · DOI 10.12703/r/10-31
Verify or expand the search:
- PubMed search for NCT04131309
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Stichting European Myeloma Network trials
Trials by the same sponsor.
- NCT04617925 — A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis · Phase 2 · completed
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- NCT03896737 — Daratumumab-bortezomib-dexamethasone (Dara-VCd) vs Bortezomib-Thalidomide-Dexamethasone (VTd), Then Maintenance With Ixa · Phase 2 · active not recruiting
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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 NCT04131309 (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 Stichting European Myeloma Network
- Last refreshed: 16 April 2025
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/NCT04131309.
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