> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-intravenously-iv-infused-etentamig-in-combination-260bd7fd-5a64-40ce-9643-a9ea675df0fd > Record changed: 2026-11-04 # Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma NCT06896916 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) Participants 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) Start date 2025-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) Number of sites 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## 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 adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state 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. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide. In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration. 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 and monitoring of side effects. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Short title** Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Official title** Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Dates **Completion date** 2036-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **First posted** 2025-03-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Registry last updated** 2026-05-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Primary completion date** 2036-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Start date** 2025-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Size and sites **Participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Planned participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Number of sites** 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Identifiers **Registry ID** NCT06896916 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **ClinicalTrials.gov ID** NCT06896916 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Outcomes ### Primary outcomes 1. Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) Timeframe: Up to Approximately 56 Days DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. 2. Number of Participants with Adverse Events (AE)s Timeframe: Up to Approximately 129 Months An adverse event 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. ### Secondary outcomes 1. Partial Response (PR) Response Rate (RR) Timeframe: Up to 3 Years PR is defined \\>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \\>= 90% or to \\< 200 mg per 24 hours, if the serum and urine M-protein are unmeasurable, a \\>= 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, if the serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a \\>= 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \\>= 30%, \\>= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline. 2. Very Good Partial Response (VGPR) RR Timeframe: Up to 3 Years VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \\>= 90% reduction in serum M-protein plus urine M-protein \\< 100 mg per 24 hours, for participants in whom the only measurable disease is by serum free light chains (FLC) levels, VGPR is defined as \\>= 90% decrease in the difference between involved and uninvolved FLC levels. 3. Complete Response (CR) RR Timeframe: Up to 3 Years CR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \\< 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio is also required. 4. Stringent Complete Response (sCR) RR Timeframe: Up to 3 Years sCR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \\< 5% plasma cells in bone marrow, normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry (kappa/lambda ratio \\<= 4:1 or \\>= 1:2 for kappa and lambda participants, respectively, after counting \\>= 100 plasma cells). 5. Overall Response Rate (ORR) Timeframe: Up to 3 Years ORR (PR + VGPR + CR + sCR) will be defined as the proportion of participants who achieved a PR or better. 6. Progression-Free Survival (PFS) Timeframe: Up to 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. 7. Duration of Response (DOR) Timeframe: Up to 3 Years DOR is 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. 8. Time-to-Progression (TTP) Timeframe: Up to 3 Years TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression. 9. Minimal Residual Disease (MRD) negativity Timeframe: Up to 3 Years The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1. - Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol. - All participants must have measurable diseases per central laboratory as outlined in protocol ### Exclusion criteria - Has received prior etentamig treatment. - Prior exposure to BCMA-targeted therapy as noted in the protocol. - Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Sites - Beverly Hills Cancer Center /ID# 266921Beverly Hills, United StatesRecruiting - Colorado Blood Cancer Institute /ID# 273751Denver, United StatesRecruiting - Washington University /ID# 266972St Louis, United StatesRecruiting - Rutgers Cancer Institute of New Jersey /ID# 266833New Brunswick, United StatesRecruiting - Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282New York, United StatesRecruiting - University Of North Carolina Health Care - Hillsborough Campus /ID# 278230Hillsborough, United StatesRecruiting - Swedish Medical Center - Seattle /ID# 268052Seattle, United StatesRecruiting - Blacktown Hospital /ID# 265983Blacktown, AustraliaRecruiting - Wollongong Hospital /ID# 265625Wollongong, AustraliaRecruiting - The Alfred Hospital /ID# 265981Melbourne, AustraliaRecruiting - Austin Hospital /ID# 265984Melbourne, AustraliaRecruiting - Sir Charles Gairdner Hospital /ID# 265985Nedlands, AustraliaRecruiting - University Health Network\_Princess Margaret Cancer Centre /ID# 275636Toronto, CanadaRecruiting - Jewish General Hospital /ID# 267574Montreal, CanadaRecruiting - Chu de Nice-Hopital Larchet Ii /Id# 266845Nice, FranceRecruiting - Hôpital La Timone /ID# 267053Marseille, FranceRecruiting - Chu De Lille - Hopital Claude Huriez /ID# 270193Lille, FranceRecruiting - Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694Tours, FranceRecruiting - IUCT Oncopole /ID# 266391Toulouse, FranceRecruiting - National Cancer Center Hospital East /ID# 268343Kashiwa-shi, JapanRecruiting - Kumamoto University Hospital /ID# 270530Kumamoto, JapanRecruiting - Dokkyo Medical University Hospital /ID# 271648Mibu, JapanRecruiting - Nippon Medical School Hospital /ID# 270254Bunkyo-ku, JapanRecruiting - The Cancer Institute Hospital Of JFCR /ID# 268342Koto-ku, JapanRecruiting - Amsterdam UMC, Location VUmc /ID# 267670Amsterdam, NetherlandsRecruiting And 2 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## References ### Other registry identifiers - 2024-512146-41-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06896916) ## Related records ### Drugs (2) - [Etentamig](https://trialight.com/data/asset/etentamig-7c89ec13-a12f-4b04-ae84-34ddfea08b6c.md) - [Iberdomide](https://trialight.com/data/asset/iberdomide-c87e8a0b-9d3e-422e-9876-8c8310fab473.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 (4) - [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) - [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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