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 (NCT05259839)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arkansas for Medical Sciences /ID# 243096 — Little Rock, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (49 Sites)
Showing the first 25 of 49 sites.
- University of Arkansas for Medical Sciences /ID# 243096 — Little Rock, Arkansas
- Sylvester Comprehensive Cancer Center /ID# 243673 — Miami, Florida
- Moffitt Cancer Center /ID# 243437 — Tampa, Florida
- University of Maryland, Baltimore /ID# 243679 — Baltimore, Maryland
- Dana-Farber Cancer Institute /ID# 249529 — Boston, Massachusetts
- University of Massachusetts - Worcester /ID# 243977 — Worcester, Massachusetts
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438 — Ann Arbor, Michigan
- The Valley Hospital /ID# 243829 — Paramus, New Jersey
- Rutenberg Cancer Center /ID# 244647 — New York, New York
- Memorial Sloan Kettering Cancer Center /ID# 244656 — New York, New York
- Atrium Health Levine Cancer Institute /ID# 242851 — Charlotte, North Carolina
- University of Texas - Southwestern Medical Center /ID# 243273 — Dallas, Texas
- Huntsman Cancer Institute /ID# 242872 — Salt Lake City, Utah
- University of Washington /ID# 243172 — Seattle, Washington
- Froedtert Memorial Lutheran Hospital /ID# 242654 — Milwaukee, Wisconsin
- St George Hospital - Kogarah /ID# 243740 — Kogarah, New South Wales
- Calvary Mater Newcastle /ID# 243730 — Waratah, New South Wales
- Monash Health - Monash Medical Centre - Clayton /ID# 244403 — Clayton, Victoria
- St Vincent's Hospital Melbourne /ID# 256879 — Fitzroy Melbourne, Victoria
- Peter MacCallum Cancer Ctr /ID# 256880 — Melbourne, Victoria
- Epworth Healthcare /ID# 243734 — Richmond, Victoria
- Fiona Stanley Hospital /ID# 244753 — Murdoch, Western Australia
- Universitaetsklinikum Tuebingen /ID# 242815 — Tübingen, Baden-Wurttemberg
- Universitaetsklinikum Regensburg /ID# 242837 — Regensburg, Bavaria
- Universitaetsklinikum Wuerzburg /ID# 242826 — Würzburg, Bavaria
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Relapsed/Refractory Multiple Myeloma
- A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets — Stanford, California
- Cevostamab Following CAR T Cell Therapy for RRMM — Philadelphia, Pennsylvania
- A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed/Refractory Myeloma — Clayton, North Carolina
- A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma — Birmingham, Alabama
- CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma — Birmingham, Alabama
Explore by condition: All Relapsed/Refractory Multiple Myeloma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.