> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-adverse-events-and-change-in-disease-dd824e0f-ed22-495c-8e39-2452f8d5a05b > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) Participants 283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) Start date 2022-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) Number of sites 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Dates **Completion date** 2033-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **First posted** 2022-03-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Registry last updated** 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Primary completion date** 2033-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Start date** 2022-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Size and sites **Actual participants** 283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Participants** 283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Number of sites** 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Identifiers **Registry ID** NCT05259839 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **ClinicalTrials.gov ID** NCT05259839 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Outcomes ### Primary outcomes 1. Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig Timeframe: Up to approximately 28 Days DLT events as described in the protocol will be assessed. 2. Number of Participants with Adverse Events (AEs) Timeframe: Up to Approximately 3 Years An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. ### Secondary outcomes 1. Overall Response Rate (ORR) Timeframe: Up to Approximately 3 Years ORR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better. 2. Progression-Free Survival (PFS) Timeframe: Up to Approximately 3 Years PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death. 3. Duration of Response (DOR) Timeframe: Up to Approximately 3 Years DOR will be defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first. 4. Time-to-Progression (TTP) Timeframe: Up to Approximately 3 Years TTP is defined as the number of days from the date of first dose to the date of earliest disease progression. 5. Percentage of Participants with Minimal Residual Diseas (MRD) Negativity by Next-Generation Sequencing (NGS) Timeframe: Up to Approximately 3 Years MRD negative status (threshold as assessed by NGS Adaptive Clonoseq) with \\>= CR (per International Myeloma Working Group \\\[IMWG\\\] response criteria) prior to the initiation of new myeloma therapy. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Sites - University of Arkansas for Medical Sciences /ID# 243096Little Rock, United States - Sylvester Comprehensive Cancer Center /ID# 243673Miami, United States - Moffitt Cancer Center /ID# 243437Tampa, United States - University of Maryland, Baltimore /ID# 243679Baltimore, United States - Dana-Farber Cancer Institute /ID# 249529Boston, United States - University of Massachusetts - Worcester /ID# 243977Worcester, United States - University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438Ann Arbor, United States - The Valley Hospital /ID# 243829Paramus, United States - Rutenberg Cancer Center /ID# 244647New York, United States - Memorial Sloan Kettering Cancer Center /ID# 244656New York, United States - Atrium Health Levine Cancer Institute /ID# 242851Charlotte, United States - University of Texas - Southwestern Medical Center /ID# 243273Dallas, United States - Huntsman Cancer Institute /ID# 242872Salt Lake City, United States - University of Washington /ID# 243172Seattle, United States - Froedtert Memorial Lutheran Hospital /ID# 242654Milwaukee, United States - St George Hospital - Kogarah /ID# 243740Kogarah, Australia - Calvary Mater Newcastle /ID# 243730Waratah, Australia - Monash Health - Monash Medical Centre - Clayton /ID# 244403Clayton, Australia - St Vincent's Hospital Melbourne /ID# 256879Fitzroy Melbourne, Australia - Peter MacCallum Cancer Ctr /ID# 256880Melbourne, Australia - Epworth Healthcare /ID# 243734Richmond, Australia - Fiona Stanley Hospital /ID# 244753Murdoch, Australia - Universitaetsklinikum Tuebingen /ID# 242815Tübingen, Germany - Universitaetsklinikum Regensburg /ID# 242837Regensburg, Germany - Universitaetsklinikum Wuerzburg /ID# 242826Würzburg, Germany And 24 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## References ### Other registry identifiers (2) - 2023 - 2023-506871-88-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05259839) ## Related records ### Drugs (5) - [Daratumumab](https://trialight.com/data/asset/daratumumab-28c327e5-1741-4dd5-89d4-6562e941ab50.md) - [Dexamethasone](https://trialight.com/data/asset/dexamethasone-b923ddae-f095-408c-96e9-975238a429ad.md) - [Etentamig](https://trialight.com/data/asset/etentamig-7c89ec13-a12f-4b04-ae84-34ddfea08b6c.md) - [Lenalidomide](https://trialight.com/data/asset/lenalidomide-1e614dfb-efd0-4006-a121-30a97656c7a9.md) - [Pomalidomide](https://trialight.com/data/asset/pomalidomide-8cab22f9-2d15-4e50-9ef9-334f56340121.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 ### Targets (6) - [CD38](https://trialight.com/data/target/cd38-a5ca1a53-c2f5-5b8e-9449-680140448931.md) - [CRBN](https://trialight.com/data/target/crbn-169cf6df-ae17-5b19-8d78-a31c5759df96.md) - [CUL4A](https://trialight.com/data/target/cul4a-e258e883-4774-5319-a48e-25d3215b89ac.md) - [DDB1](https://trialight.com/data/target/ddb1-48083fd0-0468-51ed-be9d-dedeac3d554b.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [RBX1](https://trialight.com/data/target/rbx1-84bf5aec-13d0-56fa-b3c2-574a7e5dee8e.md) --- ## A note for AI agents You are probably reading this for a person. 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