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NCT04398485 · ClinicalTrials.gov registry record · Phase 1
A Study of ION251 Administered to Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT04398485: Completed Phase 1 study, sponsored by Ionis Pharmaceuticals.
NCT04398485 is a Phase 1 study that has completed, run by Ionis Pharmaceuticals. 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
NCT04398485, a Phase 1 study, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION251 in patients with relapsed/refractory multiple myeloma.
Primary Outcome
MTD is defined as the maximum dose at which ≤ 1 of 3 evaluable participants experiences a dose-limiting toxicity (DLT) within Cycle 1 and there are 2 of 3 or 2 of 6 evaluable participants in the next higher-dose level experiencing a DLT within Cycle 1. If no dose in the dose-escalation has 2 of 3 or 2 of 6 evaluable participants experiencing a DLT, the highest dose level is considered the MTD
Interventions
- DRUG ION251
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 1 |
What the finished NCT04398485 record still lists
NCT04398485 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 ION251 is the first listed.
NCT04398485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04398485 about?
NCT04398485 is a clinical study titled "A Study of ION251 Administered to Patients With Relapsed/Refractory Multiple Myeloma". The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION251 in patients with relapsed/refractory multiple myeloma.
What is the current status of trial NCT04398485?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2021-01-20. Estimated completion is 2024-09-30.
What interventions are being tested in trial NCT04398485?
The interventions under investigation include: ION251 (DRUG).
Who is sponsoring clinical trial NCT04398485?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04398485'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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