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Assessing the safety of etentamig with cancer treatments for relapsed multiple myeloma

A Dose Escalation and Expansion Study of Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Multiple Myeloma

Phase 1 Interventional TeneoOne Inc. · NCT05259839

This study is testing how safe a new drug called etentamig is when used with standard cancer treatments for adults with relapsed multiple myeloma.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years and up
SexAll
SponsorTeneoOne Inc. Industry-sponsored
Drugs / interventionsdaratumumab
Locations49 sites (Little Rock, Arkansas and 48 other locations)
Trial IDNCT05259839 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and toxicity of etentamig (ABBV-383) when combined with established anti-cancer regimens such as pomalidomide-dexamethasone, lenalidomide-dexamethasone, or daratumumab-dexamethasone in adults with relapsed/refractory multiple myeloma. Participants will be assigned to different treatment arms based on their eligibility and previous treatments. The study includes a dose escalation phase to identify the optimal dose of etentamig, followed by a dose expansion phase to confirm its efficacy. Approximately 320 adult participants will be enrolled to assess adverse events and changes in disease activity.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed/refractory multiple myeloma who have received at least three prior lines of treatment and meet specific eligibility criteria.

Not a fit: Patients who have received BCMA-targeted therapy or have unresolved adverse events 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/refractory multiple myeloma.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific combination of etentamig with these regimens is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
* Must have confirmed diagnosis of 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) criteria.
* Must have measurable disease as determined by central lab as outlined in the protocol.
* Must be naïve to treatment with Etentamig.
* Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
* Arms A, B and C: Participant has received at least 3 prior lines of MM treatment.
* Arm E: Participant has received 1-3 prior lines of MM treatment.

Exclusion Criteria:

* Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment.
* Unresolved adverse event (AE)s \>= Grade 2 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from prior anticancer therapy.
* Has any of the following conditions:

  * Nonsecretory Multiple Myeloma (MM).
  * Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or \> 2.0 × 10\^9L circulating plasma cells by standard differential.
  * Waldenstrom's macroglobulinemia.
  * Light chain amyloidosis.
  * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
  * Major surgery within 4 weeks prior to first dose or planned study participation.
  * Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
  * Uncontrolled diabetes or hypertension within 14 days prior to first dose.
  * Peripheral neuropathy \>= Grade 3 or \>= Grade 2 with pain within 2 weeks prior to first dose.

Where this trial is running

Little Rock, Arkansas and 48 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 Relapsed/Refractory Multiple MyelomaPomalidomideDexamethasoneLenalidomideDaratumumabNirogacestatEtentamigABBV-383
Last reviewed 2026-06-13 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.