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
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma
2 other identifiers
interventional
440
5 countries
25
Brief Summary
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started Jun 2025
Longer than P75 for phase_1 multiple-myeloma
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2025
CompletedFirst Posted
Study publicly available on registry
March 24, 2025
CompletedStudy Start
First participant enrolled
June 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2036
February 17, 2026
February 1, 2026
10.6 years
March 19, 2025
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants with Adverse Events (AE)s
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.
Up to Approximately 130 Months
Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)
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.
Up to Approximately 8 weeks
Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM)
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.
Up to Approximately 8 Weeks
Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM)
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.
Up to Approximately 8 Weeks
Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM
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.
Up to Approximately 8 Weeks
Secondary Outcomes (6)
Substudy 1, 2, 3, 4: Complete Response Rate
Up to Approximately 1 Year
Substudy 1, 2, 3, 4: Overall Response Rate (ORR)
Up to Approximately 1 Year
Substudy 1, 2, 3, 4: Progression Free Survival (PFS)
Up to Approximately 130 Months
Substudy 1, 2, 3, 4: Duration of Response (DOR)
Up to Approximately 130 Months
Substudy 1, 2, 3, 4: Time-to-Progression (TTP)
Up to Approximately 130 Months
- +1 more secondary outcomes
Study Arms (15)
Substudy 1: Etentamig Dose Escalation
EXPERIMENTALParticipants will receive escalating etentamig in combination with daratumumab, and lenalidomide (DR), as part of the approximately 130 month study duration.
Substudy 1: Etentamig Dose Expansion Dose Level 1
EXPERIMENTALParticipants will receive dose level 1 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Substudy 1: Etentamig Dose Expansion Dose Level 2
EXPERIMENTALParticipants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Substudy 1: Comparator
EXPERIMENTALParticipants will receive daratumumab, lenalidomide, and dexamethasone (DRd), as part of the approximately 130 month study duration.
Substudy 2: Etentamig Dose Escalation
EXPERIMENTALParticipants will receive escalating etentamig, as part of the approximately 130 month study duration.
Substudy 2: Etentamig Dose Expansion Dose Level 1
EXPERIMENTALParticipants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration.
Substudy 2: Etentamig Dose Expansion Dose Level 2
EXPERIMENTALParticipants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration.
Substudy 2: Comparator
EXPERIMENTALParticipants will receive lenalidomide (R), as part of the approximately 130 month study duration.
Substudy 3: Etentamig Dose Escalation
EXPERIMENTALParticipants will receive escalating etentamig in combination with carfilzomib, and dexamethasone (Kd), as part of the approximately 130 month study duration.
Substudy 3: Etentamig Dose Expansion Dose Level 1
EXPERIMENTALParticipants will receive dose level 1 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Substudy 3: Etentamig Dose Expansion Dose Level 2
EXPERIMENTALParticipants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Substudy 3: Comparator
EXPERIMENTALParticipants will receive daratumumab, carfilzomib, and dexamethasone (DKd), as part of the approximately 130 month study duration.
Substudy 4: Etentamig Dose Escalation
EXPERIMENTALParticipants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration.
Substudy 4: Etentamig Dose Expansion Dose Level 1
EXPERIMENTALParticipants will receive dose level 1 of etentamig in combination with R, as part of the approximately 130 month study duration.
Substudy 4: Etentamig Dose Expansion Dose Level 2
EXPERIMENTALParticipants will receive dose level 2 of etentamig in combination with R, as part of the approximately 130 month study duration.
Interventions
Intravenous (IV) Infusion
Oral Capsule
Subcutaneous Injection
IV Injection
IV Infusion
Eligibility Criteria
You may qualify if:
- Eastern cooperative oncology group (ECOG) performance of \<= 1.
- 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.
You may not qualify if:
- Participant who has known active central nervous system involvement of MM.
- Participant who has known active infection as outlined in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (25)
Colorado Blood Cancer Institute /ID# 273129
Denver, Colorado, 80218, United States
Moffitt Cancer Center /ID# 272628
Tampa, Florida, 33612, United States
Winship Cancer Institute of Emory University /ID# 274830
Atlanta, Georgia, 30322, United States
Weill Cornell Medical College /ID# 272517
New York, New York, 10065, United States
University of North Carolina at Chapel Hill /ID# 274667
Chapel Hill, North Carolina, 27514, United States
Atrium Health Levine Cancer Institute /ID# 276193
Charlotte, North Carolina, 28204-2990, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 274847
Winston-Salem, North Carolina, 27157, United States
Oncology Hematology Care - Kenwood /ID# 272918
Cincinnati, Ohio, 45236, United States
Coffs Harbour Health Campus /ID# 272010
Coffs Harbour, New South Wales, 2450, Australia
Port Macquarie Base Hospital /ID# 275925
Port Macquarie, New South Wales, 2444, Australia
Westmead Hospital /ID# 271880
Westmead, New South Wales, 2145, Australia
Icon Cancer Care - South Brisbane /ID# 271836
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital /ID# 272629
Adelaide, South Australia, 5000, Australia
St Vincent's Hospital - Melbourne /ID# 276451
Fitzroy, Victoria, 3065, Australia
Peter MacCallum Cancer Centre /ID# 272024
Melbourne, Victoria, 3000, Australia
The Perth Blood Institute - West Perth /ID# 272469
West Perth, Western Australia, 6005, Australia
Soroka Medical Center /ID# 271367
Beersheba, Southern District, 8410101, Israel
The Chaim Sheba Medical Center /ID# 271366
Ramat Gan, Tel Aviv, 5265601, Israel
Rambam Health Care Campus- Haifa /ID# 271364
Haifa, 3525408, Israel
Hadassah Medical Center-Hebrew University /ID# 271362
Jerusalem, 91120, Israel
Rabin Medical Center. /ID# 271365
Petah Tikva, 4941492, Israel
Nagoya City University Hospital /ID# 273529
Nagoya, Aichi-ken, 467-8602, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 275713
Kyoto, Kyoto, 602-8566, Japan
The University of Osaka Hospital /ID# 275791
Suita-shi, Osaka, 565-0871, Japan
Hammersmith Hospital /ID# 274615
London, England, W12 0HS, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2025
First Posted
March 24, 2025
Study Start
June 30, 2025
Primary Completion (Estimated)
February 1, 2036
Study Completion (Estimated)
March 1, 2036
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.