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NCT03836053 · ClinicalTrials.gov registry record · Phase 1
Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03836053: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT03836053 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03836053, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
To confirm the maximum tolerated dose (MTD) from the BI 836909 trial of 400 mcg/d, given as 28-day continuous intravenous infusion in patients with relapsed and/or refractory multiple myeloma, to test the 600 mcg/d dose, given as a 28-day continuous iV infusion.
Primary Outcome
DLTs were graded using Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with the exception of cytokine release syndrome (CRS) and tumor lysis syndrome (TLS), which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008 respectively. A participant was non-DLT evaluable if they dropped out before completion of the DLT-evaluable period for reasons other than a DLT.
Interventions
- DRUG AMG 420
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2019-03-04 |
| Est. Completion | 2022-04-21 |
| Phase | Phase 1 |
Why NCT03836053 stopped before completion
NCT03836053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which AMG 420 is the first listed.
NCT03836053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03836053 about?
NCT03836053 is a clinical study titled "Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma". To confirm the maximum tolerated dose (MTD) from the BI 836909 trial of 400 mcg/d, given as 28-day continuous intravenous infusion in patients with relapsed and/or refractory multiple myeloma, to test the 600 mcg/d dose, given as a 28-day continuous iV infusion.
What is the current status of trial NCT03836053?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2019-03-04. Estimated completion is 2022-04-21.
What interventions are being tested in trial NCT03836053?
The interventions under investigation include: AMG 420 (DRUG).
Who is sponsoring clinical trial NCT03836053?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03836053's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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