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
NCT ID: NCT06896916
Last Updated: 2025-12-26
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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RECRUITING
PHASE1
135 participants
INTERVENTIONAL
2025-08-07
2036-03-31
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. 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: ABBV-383 Dose Escalation
In phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration.
Etentamig
Intravenous (IV) Infusion
Iberdomide
Oral Capsule
Phase 2: ABBV-383 Dose Expansion Dose A
In phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration.
Etentamig
Intravenous (IV) Infusion
Iberdomide
Oral Capsule
Phase 2: ABBV-383 Dose Expansion Dose B
In phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration.
Etentamig
Intravenous (IV) Infusion
Iberdomide
Oral Capsule
Interventions
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Etentamig
Intravenous (IV) Infusion
Iberdomide
Oral Capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior exposure to BCMA-targeted therapy as noted in the protocol.
* Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).
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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Beverly Hills Cancer Center /ID# 266921
Beverly Hills, California, United States
Colorado Blood Cancer Institute /ID# 273751
Denver, Colorado, United States
Washington University /ID# 266972
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey /ID# 266833
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282
New York, New York, United States
Swedish Cancer Institute /ID# 268052
Seattle, Washington, United States
Blacktown Hospital /ID# 265983
Blacktown, New South Wales, Australia
Wollongong Hospital /ID# 265625
Wollongong, New South Wales, Australia
The Alfred Hospital /ID# 265981
Melbourne, Victoria, Australia
Austin Hospital /ID# 265984
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital /ID# 265985
Nedlands, Western Australia, Australia
Jewish General Hospital /ID# 267574
Montreal, Quebec, Canada
Hôpital La Timone /ID# 267053
Marseille, Bouches-du-Rhone, France
Chu De Lille - Hopital Claude Huriez /ID# 270193
Lille, Hauts-de-France, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694
Tours, Indre-et-Loire, France
IUCT Oncopole /ID# 266391
Toulouse, Occitanie, France
Kumamoto University Hospital /ID# 270530
Kumamoto, Kumamoto, Japan
Dokkyo Medical University Hospital /ID# 271648
Mibu, Tochigi, Japan
Nippon Medical School Hospital /ID# 270254
Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR /ID# 268342
Koto-ku, Tokyo, Japan
Amsterdam UMC, Location VUmc /ID# 267670
Amsterdam, North Holland, Netherlands
Universitair Medisch Centrum Utrecht /ID# 267660
Utrecht, , Netherlands
Oslo Universitetssykehus Ulleval /ID# 275433
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2024-512146-41-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-555
Identifier Type: -
Identifier Source: org_study_id