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
NCT ID: NCT05259839
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
283 participants
INTERVENTIONAL
2022-10-20
2033-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone)
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.
Etentamig
Intravenous (IV) Infusion
Dexamethasone
Oral; Tablet or IV Infusion
Pomalidomide
Oral; Capsule
Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.
Etentamig
Intravenous (IV) Infusion
Dexamethasone
Oral; Tablet or IV Infusion
Lenalidomide
Oral; Capsule
Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
Etentamig
Intravenous (IV) Infusion
Dexamethasone
Oral; Tablet or IV Infusion
Daratumumab
Subcutaneous Injection (SC)
Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.
Etentamig
Intravenous (IV) Infusion
Dexamethasone
Oral; Tablet or IV Infusion
Pomalidomide
Oral; Capsule
Interventions
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Etentamig
Intravenous (IV) Infusion
Dexamethasone
Oral; Tablet or IV Infusion
Lenalidomide
Oral; Capsule
Pomalidomide
Oral; Capsule
Daratumumab
Subcutaneous Injection (SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Arkansas for Medical Sciences /ID# 243096
Little Rock, Arkansas, United States
Sylvester Comprehensive Cancer Center /ID# 243673
Miami, Florida, United States
Moffitt Cancer Center /ID# 243437
Tampa, Florida, United States
University of Maryland, Baltimore /ID# 243679
Baltimore, Maryland, United States
Dana-Farber Cancer Institute /ID# 249529
Boston, Massachusetts, United States
University of Massachusetts - Worcester /ID# 243977
Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438
Ann Arbor, Michigan, United States
The Valley Hospital /ID# 243829
Paramus, New Jersey, United States
Rutenberg Cancer Center /ID# 244647
New York, New York, United States
Memorial Sloan Kettering Cancer Center /ID# 244656
New York, New York, United States
Atrium Health Levine Cancer Institute /ID# 242851
Charlotte, North Carolina, United States
University of Texas Southwestern Medical Center /ID# 243273
Dallas, Texas, United States
Huntsman Cancer Institute /ID# 242872
Salt Lake City, Utah, United States
University of Washington /ID# 243172
Seattle, Washington, United States
Froedtert Memorial Lutheran Hospital /ID# 242654
Milwaukee, Wisconsin, United States
St George Hospital /ID# 243740
Kogarah, New South Wales, Australia
Calvary Mater Newcastle /ID# 243730
Waratah, New South Wales, Australia
Monash Health - Monash Medical Centre /ID# 244403
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 256879
Fitzroy Melbourne, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 256880
Melbourne, Victoria, Australia
Epworth Healthcare /ID# 243734
Richmond, Victoria, Australia
Fiona Stanley Hospital /ID# 244753
Murdoch, Western Australia, Australia
Universitaetsklinikum Tuebingen /ID# 242815
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Wuerzburg /ID# 242826
Würzburg, Bavaria, Germany
Universitaetsklinikum Essen /ID# 242819
Essen, , Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 243141
Hamburg, , Germany
Universitaetsklinikum Regensburg /ID# 242837
Regensburg, , Germany
IRCCS Ospedale San Raffaele /ID# 242583
Milan, Milano, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 242584
Meldola, Reggio Emilia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 242582
Rome, Roma, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 242581
Bologna, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 244057
Milan, , Italy
Nagoya City University Hospital /ID# 249094
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 245889
Kashiwa-shi, Chiba, Japan
Hokkaido University Hospital /ID# 245966
Sapporo, Hokkaido, Japan
Kanazawa University Hospital /ID# 246812
Kanazawa, Ishikawa-ken, Japan
Okayama Medical Center /ID# 245882
Okayama, Okayama-ken, Japan
Yamagata University Hospital /ID# 245888
Yamagata, Yamagata, Japan
Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954
Opole, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny We Wrocławiu /ID# 243246
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 243500
Lublin, Lublin Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne /ID# 243249
Gdansk, Pomeranian Voivodeship, Poland
Hospital Duran i Reynals /ID# 242979
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra - Pamplona /ID# 242977
Pamplona, Navarre, Spain
Hospital Universitario Vall de Hebron /ID# 242976
Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 242978
Barcelona, , Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 242975
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 242974
Seville, , Spain
Countries
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Related Links
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Other Identifiers
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2023-506871-88-00
Identifier Type: OTHER
Identifier Source: secondary_id
M22-947
Identifier Type: -
Identifier Source: org_study_id