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Clinical trial · no report yet · Phase 3

NCT03301220

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

  • NCT03301220 ↗
  • Completed
  • Janssen Research & Development, LLC
  • 3 commentary sources found
  • Focused

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built. Commentary is thin so far, so the report would be short.

ChannelFound
X threads3

The trial

ClinicalTrials.gov
Official title
A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple Myeloma
Phase
Phase 3
Status
Completed
Conditions
Smoldering Multiple Myeloma
Interventions
Daratumumab SC: daratumumab + rHuPH20
Arms
  • Arm A: Active Monitoring · No intervention
  • Arm B: Daratumumab SC · Experimental
Enrollment
390
Primary outcomes
  • Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Sponsor
Janssen Research & Development, LLC
Start
Nov 7, 2017
Primary completion
May 1, 2024
Results posted
Yes
Registry record
NCT03301220 · updated Jun 8, 2026

Publications

linked from the registry
  • Suzuki K, Kosugi H, Ito T, Takamatsu Y, Voorhees PM, Rajkumar SV, Ito M, Sakai C, Takahashi M, Nakatogawa T, Dennis R, Carson R, Dimopoulos MA. Japanese subgroup analysis of AQUILA trial: daratumumab vs active monitoring in high-risk smoldering multiple myeloma. Jpn J Clin Oncol. 2026 Sep 16:hyag146. doi: 10.1093/jjco/hyag146. Online ahead of print. PubMed 42747040
  • Dimopoulos MA, Voorhees PM, Schjesvold F, Cohen YC, Hungria V, Sandhu I, Lindsay J, Baker RI, Suzuki K, Kosugi H, Levin MD, Beksac M, Stockerl-Goldstein K, Oriol A, Mikala G, Garate G, Theunissen K, Spicka I, Mylin AK, Bringhen S, Uttervall K, Pula B, Medvedova E, Cowan AJ, Moreau P, Mateos MV, Goldschmidt H, Ahmadi T, Sha L, Cortoos A, Katz EG, Rousseau E, Li L, Dennis RM, Carson R, Rajkumar SV; AQUILA Investigators. Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma. N Engl J Med. 2025 May 8;392(18):1777-1788. doi: 10.1056/NEJMoa2409029. Epub 2024 Dec 9. PubMed 39652675