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NCT06223516 · ClinicalTrials.gov registry record · Phase 1
Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study of Multiple Myeloma, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 15
- Study locations
NCT06223516: Recruiting Phase 1 study of Multiple Myeloma, sponsored by AbbVie.
NCT06223516 is a Phase 1 study of Multiple Myeloma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 55 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06223516, a Phase 1 study of Multiple Myeloma, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 15
- Study locations
Study Summary
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of Etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 15 sites across the world In Arm A participants will receive one of two doses of Etentamig (ABBV-383) as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
Primary Outcome
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
Conditions Studied
Interventions
- DRUG Subcutaneous (SC) Etentamig
- DRUG Intravenous (IV) Etentamig
Study Locations (15)
Florida
- Mayo Clinic Hospital Jacksonville /ID# 262808 - Jacksonville
- Sylvester Comprehensive Cancer Center /ID# 260798 - Miami
Tel Aviv
- The Chaim Sheba Medical Center /ID# 261699 - Ramat Gan
- Tel Aviv Sourasky Medical Center /ID# 261525 - Tel Aviv
Arizona
- Mayo Clinic Arizona /ID# 260799 - Phoenix
Michigan
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050 - Ann Arbor
Minnesota
- Mayo Clinic - Rochester /ID# 262807 - Rochester
North Carolina
- Atrium Health Wake Forest Baptist Medical Center /ID# 260807 - Winston-Salem
Wisconsin
- Wisconsin Medical Center /ID# 261085 - Milwaukee
Hesse
- Universitaetsklinikum Frankfurt /ID# 260442 - Frankfurt am Main
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2024-06-17 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT06223516 shows while recruiting
NCT06223516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Subcutaneous (SC) Etentamig is the first listed.
NCT06223516 lists 15 locations in 13 states (Florida, Tel Aviv, Arizona).
Frequently Asked Questions
What is clinical trial NCT06223516 about?
NCT06223516 is a clinical study titled "Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma". Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed...
What is the current status of trial NCT06223516?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2024-06-17. Estimated completion is 2027-12.
What conditions does trial NCT06223516 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT06223516?
The interventions under investigation include: Subcutaneous (SC) Etentamig (DRUG), Intravenous (IV) Etentamig (DRUG).
Who is sponsoring clinical trial NCT06223516?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06223516 being conducted?
This trial has 15 study locations across Arizona, Florida, Michigan, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06223516's enrollment target sits among peer trials
55 240th of 438 higher than 199 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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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