> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-adverse-events-of-intravenously-iv-infused-6bf07f70-bec7-4df8-afc7-0697435286a3 > Record changed: 2026-10-13 # A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma NCT05650632 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) Participants 210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) Start date 2023-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) Number of sites 46 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Title and summary **Summary** Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \\& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \\& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world. Participants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Short title** A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Dates **Completion date** 2029-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **First posted** 2022-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Registry last updated** 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Primary completion date** 2029-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Start date** 2023-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Size and sites **Participants** 210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Planned participants** 210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Number of sites** 46 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Identifiers **Registry ID** NCT05650632 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **ClinicalTrials.gov ID** NCT05650632 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Outcomes ### Primary outcomes 1. Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events Timeframe: Up to Day 28 CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines 2. Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome \[ICANS\]) Timeframe: Up to Day 28 AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. ### Secondary outcomes 1. Arm A, Arm C. and Arm D: Number of Cytokine Release Syndrome (CRS) Events Timeframe: Up to 3 Years CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Sites - Mayo Clinic Arizona /ID# 251405Phoenix, United StatesRecruiting - Highlands Oncology Group - Springdale /ID# 267742Springdale, United StatesRecruiting - Rocky Mountain Cancer Centers - Aurora /ID# 268574Aurora, United StatesRecruiting - Medical Oncology Hematology Consultants /ID# 268560Newark, United StatesRecruiting - Hope And Healing Cancer Services /ID# 268536Hinsdale, United StatesRecruiting - Fort Wayne Medical Oncology And Hematology /ID# 268179Fort Wayne, United StatesRecruiting - Franciscan St. Francis Health /ID# 280928Indianapolis, United StatesRecruiting - Tulane University School of Medicine /ID# 251204New Orleans, United StatesRecruiting - Maryland Oncology Hematology - Silver Spring /ID# 268562Silver Spring, United StatesNot yet recruiting - Mayo Clinic - Rochester /ID# 251164Rochester, United StatesRecruiting - NHO Revive Research Institute, LLC /ID# 267869Lincoln, United StatesRecruiting - Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497Omaha, United StatesRecruiting - Mt Sinai /ID# 251166New York, United StatesRecruiting - Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167New York, United StatesRecruiting - University of North Carolina /ID# 251203Chapel Hill, United StatesRecruiting - Atrium Health Wake Forest Baptist Medical Center /ID# 251165Winston-Salem, United StatesRecruiting - University Of Cincinnati Medical Center /ID# 251746Cincinnati, United StatesRecruiting - Willamette Valley Cancer Institute and Research Center /ID# 267088Eugene, United StatesRecruiting - Baptist Memorial Hospital /ID# 280677Memphis, United StatesNot yet recruiting - Vanderbilt Ingram Cancer Center /ID# 252470Nashville, United StatesRecruiting - Texas Oncology - Central/South Texas /ID# 268563Austin, United StatesRecruiting - Texas Oncology - Dallas - Worth Street /ID# 280064Dallas, United StatesRecruiting - Oncology Consultants /ID# 268323Houston, United StatesRecruiting - Texas Oncology - Northeast Texas /ID# 268877Tyler, United StatesRecruiting - Virginia Cancer Specialists - Fairfax /ID# 268559Fairfax, United StatesRecruiting And 21 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## References ### Other registry identifiers (2) - 2023 - 2023-504674-38-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650632) ## Related records ### Drugs (1) - [Etentamig](https://trialight.com/data/asset/etentamig-7c89ec13-a12f-4b04-ae84-34ddfea08b6c.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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