Etentamig

A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

What's the purpose of the trial?

This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. 

Trial status

Accepting patients

Phase
Phase 1
Enrollment
180
Last Updated
2 months ago

Participating Centers

There are 24 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Etentamig is a bi-specific antibody, meaning that it interacts with two molecules in your body. One molecule is called B-Cell Maturation Antigen (BMCA) and is found on your multiple myeloma cells. The second is called CD3 and is present on your killer T-cells.

Published Results

Explore published results and other resources associated with this clinical trial (including press releases, news articles and videos).

A Phase 1b Study of Step-up Dosing with ABBV-383, a B-Cell Maturation Antigen (BCMA) x CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Multiple Myeloma

Results: As of April 2024, 70 pts were enrolled in Arm A: 47 in DO (2 mg SUD, n=26; 4 mg SUD, n=21) and 23 in DE. Median age was 69 years (range: 40–84), 59% were male, and 76% were triple-class refractory. Median prior lines of therapy was 4 (range: 3–10). Median follow-up time (months [mo]) was 6.5, 7.5, and 2.8 for 2 mg DO, 4 mg DO, and DE, respectively. Any grade CRS was reported in 10 (39%) and 11 (52%) pts during DO at 2 and 4 mg SUD; CRS grade ≥2 occurred in 3 (12%) pts in the 2 mg SUD and in 6 (29%) pts in the 4 mg SUD, leading to selection of 2 mg SUD for DE. In the DE, 7 (30%) pts experienced CRS; 1 (4%) pt experienced grade 2 CRS, there were no grade ≥3 events, and only 2 (9%) pts received tocilizumab to treat CRS. Overall, median time to CRS onset and resolution was 14.7 and 9 hours, respectively; no pts had CRS after C1. Immune effector cell-associated neurotoxicity syndrome occurred in 7 (10%) pts (grade 1: 4%; grade 2: 6%; grade 3: 4%). Most common TEAEs were CRS (40%), neutropenia (37%), diarrhea (29%), anemia (24%), and fatigue (20%); most common grade 3/4 TEAEs were neutropenia (31%), anemia (19%), thrombocytopenia (13%), and leukopenia (11%). Grade 5 TEAEs occurred in 5 pts; 1 event was deemed possibly related to ABBV-383 (COVID-19 pneumonia). In the efficacy-evaluable population (n=68), the objective response rate was 62% (95% CI: 49.2, 73.3); 35 (52%) pts had a VGPR or better. Median time to response was 1.1 mo (range: 1–4) and median duration of follow-up was 5.8 mo (range: 1–12). Response rates are expected to improve with longer follow-up. Maximum reduction in peak levels of CRS-related cytokines, including IL-6, were observed in DE compared with DO and 60 mg Q4W without SUD (FIH study). Peak activation and proliferation of CD8 T cells was comparable with ABBV-383 in DO, DE, and 60 mg Q4W-treated pts.

Conclusions: Introduction of 1 SUD of 2 mg on D1 followed by full dose of 60 mg on D4 in C1 combined with modification to the Dex premed schedule reduced the incidence and severity of CRS in pts with RRMM, further optimizing the safety profile of ABBV-383. Preliminary efficacy data show early and high response rates, consistent with outcomes from other ABBV-383 studies.

7 months ago Read more

Real People. Real Support.

Need help connecting with this clinical trial? We're here to help!

Print a patient-friendly report to share with your patient.

We can help answer any questions and connect you (or your patient) with the study team.

Schedule a time that is convenient and we’ll call you to see how we can help you and your patient.