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Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma
NCT06223516 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06223516
The ClinicalTrials.gov registry entry for NCT06223516 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06223516 reports 15 study locations spanning 13 distinct geographic areas — top geographies include Florida, Tel Aviv, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06223516?
The interventions under investigation include: Subcutaneous (SC) Etentamig (DRUG), Intravenous (IV) Etentamig (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06223516?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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