A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib
NCT ID: NCT06892522
Last Updated: 2025-11-13
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/PHASE2
440 participants
INTERVENTIONAL
2025-06-30
2036-03-31
Brief Summary
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Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide
In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.
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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Substudy 1: Etentamig Dose Escalation
Participants will receive escalating etentamig in combination with daratumumab, and lenalidomide (DR), as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Daratumumab
Subcutaneous Injection
Substudy 1: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Daratumumab
Subcutaneous Injection
Substudy 1: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Daratumumab
Subcutaneous Injection
Substudy 1: Comparator
Participants will receive daratumumab, lenalidomide, and dexamethasone (DRd), as part of the approximately 130 month study duration.
Lenalidomide
Oral Capsule
Dexamethasone
IV Injection
Daratumumab
Subcutaneous Injection
Dexamethasone
Oral Tablet
Substudy 2: Etentamig Dose Escalation
Participants will receive escalating etentamig, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Substudy 2: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Substudy 2: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Substudy 2: Comparator
Participants will receive lenalidomide (R), as part of the approximately 130 month study duration.
Lenalidomide
Oral Capsule
Substudy 3: Etentamig Dose Escalation
Participants will receive escalating etentamig in combination with carfilzomib, and dexamethasone (Kd), as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Dexamethasone
IV Injection
Dexamethasone
Oral Tablet
Carfilzomib
IV Infusion
Substudy 3: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Dexamethasone
IV Injection
Dexamethasone
Oral Tablet
Carfilzomib
IV Infusion
Substudy 3: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Dexamethasone
IV Injection
Dexamethasone
Oral Tablet
Carfilzomib
IV Infusion
Substudy 3: Comparator
Participants will receive daratumumab, carfilzomib, and dexamethasone (DKd), as part of the approximately 130 month study duration.
Dexamethasone
IV Injection
Daratumumab
Subcutaneous Injection
Dexamethasone
Oral Tablet
Carfilzomib
IV Infusion
Substudy 4: Etentamig Dose Escalation
Participants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Substudy 4: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig in combination with R, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Substudy 4: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig in combination with R, as part of the approximately 130 month study duration.
Etentamig
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Interventions
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Etentamig
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Dexamethasone
IV Injection
Daratumumab
Subcutaneous Injection
Dexamethasone
Oral Tablet
Carfilzomib
IV Infusion
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria with either newly diagnosed or relapsed or refractory (RR) MM, depending on the substudy.
Exclusion Criteria
* Participant who has known active infection as outlined in the protocol.
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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Colorado Blood Cancer Institute /ID# 273129
Denver, Colorado, United States
University of North Carolina at Chapel Hill /ID# 274667
Chapel Hill, North Carolina, United States
Oncology Hematology Care - Kenwood /ID# 272918
Cincinnati, Ohio, United States
Coffs Harbour Health Campus /ID# 272010
Coffs Harbour, New South Wales, Australia
Port Macquarie Base Hospital /ID# 275925
Port Macquarie, New South Wales, Australia
Westmead Hospital /ID# 271880
Westmead, New South Wales, Australia
Icon Cancer Care - South Brisbane /ID# 271836
South Brisbane, Queensland, Australia
Royal Adelaide Hospital /ID# 272629
Adelaide, South Australia, Australia
St Vincent's Hospital - Melbourne /ID# 276451
Fitzroy, Victoria, Australia
Peter MacCallum Cancer Centre /ID# 272024
Melbourne, Victoria, Australia
The Perth Blood Institute - West Perth /ID# 272469
West Perth, Western Australia, Australia
Soroka Medical Center /ID# 271367
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 271366
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 271364
Haifa, , Israel
Hadassah Medical Center-Hebrew University /ID# 271362
Jerusalem, , Israel
Rabin Medical Center /ID# 271365
Petah Tikva, , Israel
Nagoya City University Hospital /ID# 273529
Nagoya, Aichi-ken, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 275713
Kyoto, Kyoto, Japan
The University of Osaka Hospital /ID# 275791
Suita-shi, Osaka, Japan
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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2024-515770-27-00
Identifier Type: OTHER
Identifier Source: secondary_id
M25-059
Identifier Type: -
Identifier Source: org_study_id