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Assessing the safety of ABBV-383 in adults with relapsed or refractory multiple myeloma

A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma

Phase 1 Interventional AbbVie · NCT05650632

This study is testing a new drug called ABBV-383 to see if it's safe for adults with relapsed or refractory multiple myeloma and how it affects their symptoms.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment210 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsCAR-T, chimeric antigen receptor
Locations42 sites (Phoenix, Arizona and 41 other locations)
Trial IDNCT05650632 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and adverse events associated with ABBV-383, an investigational drug, in adult participants suffering from relapsed or refractory multiple myeloma. The trial is structured into three arms, with Arm A focusing on dose optimization and expansion, while Arms B and C involve different treatment regimens based on prior therapies. Participants will receive intravenous infusions of ABBV-383, and the study aims to monitor changes in disease symptoms and any adverse reactions. The study is designed to gather critical data on the drug's efficacy and safety profile in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have received multiple lines of prior therapy.

Not a fit: Patients who have not been previously treated for multiple myeloma or those with ECOG performance status greater than 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Other studies have shown promise with similar approaches targeting B-cell maturation antigen in multiple myeloma, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Must have measurable disease as outlined in the protocol.
* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C and Arm D: ECOG performance of \<= 1.
* Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
* Must be naïve to treatment with etentamig (ABBV-383).
* Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
* Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA).
* Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
* Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).

Exclusion Criteria:

* Arm A: Received BCMA-targeted therapy.
* Arm C and Arm D: Rapidly progressing disease per investigator.

Where this trial is running

Phoenix, Arizona and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaCancerABBV-383B-Cell Maturation Antigen
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.