A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma
Public ClinicalTrials.gov record NCT05259839. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), or daratumumab-dexamethasone (Dd), in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Etentamig co-administered with Pd, Rd, or Dd, will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of etentamig, followed by a dose expansion phase to confirm the dose. Approximately 320 adult participants with R/R MM will be enrolled in the study in approximately 48 sites worldwide. Participants will receive intravenous (IV) etentamig co-administered with oral/IV Pd, oral/IV Rd, or oral/IV/subcutaneous (SC) Dd in 28-day cycles. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Study identification
- NCT ID
- NCT05259839
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 283 participants
Conditions and interventions
Conditions
Interventions
- Etentamig Drug
- Dexamethasone Drug
- Lenalidomide Drug
- Pomalidomide Drug
- Daratumumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 19, 2022
- Primary completion
- Aug 31, 2033
- Completion
- Aug 31, 2033
- Last update posted
- Aug 13, 2026
2022 – 2033
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences /ID# 243096 | Little Rock | Arkansas | 72205 | — |
| Sylvester Comprehensive Cancer Center /ID# 243673 | Miami | Florida | 33136-1002 | — |
| Moffitt Cancer Center /ID# 243437 | Tampa | Florida | 33612-9416 | — |
| University of Maryland, Baltimore /ID# 243679 | Baltimore | Maryland | 21201 | — |
| Dana-Farber Cancer Institute /ID# 249529 | Boston | Massachusetts | 02215 | — |
| University of Massachusetts - Worcester /ID# 243977 | Worcester | Massachusetts | 01655 | — |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438 | Ann Arbor | Michigan | 48109 | — |
| The Valley Hospital /ID# 243829 | Paramus | New Jersey | 07652 | — |
| Rutenberg Cancer Center /ID# 244647 | New York | New York | 10029-6030 | — |
| Memorial Sloan Kettering Cancer Center /ID# 244656 | New York | New York | 10065-6007 | — |
| Atrium Health Levine Cancer Institute /ID# 242851 | Charlotte | North Carolina | 28204 | — |
| University of Texas - Southwestern Medical Center /ID# 243273 | Dallas | Texas | 75235 | — |
| Huntsman Cancer Institute /ID# 242872 | Salt Lake City | Utah | 84112-5500 | — |
| University of Washington /ID# 243172 | Seattle | Washington | 98109 | — |
| Froedtert Memorial Lutheran Hospital /ID# 242654 | Milwaukee | Wisconsin | 53226-3522 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05259839, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05259839 live on ClinicalTrials.gov.