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NCT07409246 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM)
A Phase 1 study, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 127
- Enrollment target
NCT07409246: Recruiting Phase 1 study, sponsored by AbbVie.
NCT07409246 is a Phase 1 study that is actively recruiting participants, run by AbbVie. The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07409246, a Phase 1 study, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
Study Summary
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety, tolerability, and how ABBV-438 moves through the body, in adult participants with relapsed/refractory (R/R) MM. Adverse events, tolerability, how ABBV-438 moves through the body will be assessed. ABBV-438 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms broken into 2 parts. ABBV-438 will be given alone and multiple doses will be explored. This study will include a dose escalation phase (Part 1) to determine the best dose of ABBV-438, followed by a dose expansion phase (Part 2) to confirm the dose. Approximately 127 adult participants with R/R MM will be enrolled in the study in approximately 24 sites worldwide. Participants will receive intravenous (IV) ABBV-438 alone first in multiple doses in the dose escalation phase (Part 1); then in 1 of 2 doses from Part 1 in the dose expansion phase (Part 2). The overall study duration will be approximately 69.5 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence, whether associated with study drug or not, that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disabi
Interventions
- DRUG ABBV-438
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2026-02-27 |
| Est. Completion | 2031-11 |
| Phase | Phase 1 |
What NCT07409246 shows while recruiting
NCT07409246 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher).
The record links to 0 conditions, and to 1 intervention - of which ABBV-438 is the first listed.
NCT07409246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07409246 about?
NCT07409246 is a clinical study titled "A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM)". Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety, tolerability, and how ABBV-438 moves through the body, in adult participants with relapsed/refractory (R/R) MM. Adverse events, tol...
What is the current status of trial NCT07409246?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2026-02-27. Estimated completion is 2031-11.
What interventions are being tested in trial NCT07409246?
The interventions under investigation include: ABBV-438 (DRUG).
Who is sponsoring clinical trial NCT07409246?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07409246's enrollment target sits among peer trials
127 459th of 2000 higher than 1,540 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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