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
Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
2 other identifiers
interventional
135
7 countries
26
Brief 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.
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 Aug 2025
Longer than P75 for phase_1 multiple-myeloma
26 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 26, 2025
CompletedStudy Start
First participant enrolled
August 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2036
March 30, 2026
March 1, 2026
10.6 years
March 19, 2025
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
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 56 Days
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 129 Months
Secondary Outcomes (9)
Partial Response (PR) Response Rate (RR)
Up to 3 Years
Very Good Partial Response (VGPR) RR
Up to 3 Years
Complete Response (CR) RR
Up to 3 Years
Stringent Complete Response (sCR) RR
Up to 3 Years
Overall Response Rate (ORR)
Up to 3 Years
- +4 more secondary outcomes
Study Arms (3)
Phase 1: ABBV-383 Dose Escalation
EXPERIMENTALIn phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration.
Phase 2: ABBV-383 Dose Expansion Dose A
EXPERIMENTALIn phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration.
Phase 2: ABBV-383 Dose Expansion Dose B
EXPERIMENTALIn phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration.
Interventions
Oral Capsule
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (26)
Beverly Hills Cancer Center /ID# 266921
Beverly Hills, California, 90211, United States
Colorado Blood Cancer Institute /ID# 273751
Denver, Colorado, 80218, United States
Washington University /ID# 266972
St Louis, Missouri, 63110, United States
Rutgers Cancer Institute of New Jersey /ID# 266833
New Brunswick, New Jersey, 08901, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282
New York, New York, 10065, United States
University Of North Carolina Health Care - Hillsborough Campus /ID# 278230
Hillsborough, North Carolina, 27278, United States
Swedish Medical Center - Seattle /ID# 268052
Seattle, Washington, 98104, United States
Blacktown Hospital /ID# 265983
Blacktown, New South Wales, 2148, Australia
Wollongong Hospital /ID# 265625
Wollongong, New South Wales, 2500, Australia
The Alfred Hospital /ID# 265981
Melbourne, Victoria, 3004, Australia
Austin Hospital /ID# 265984
Melbourne, Victoria, 3084, Australia
Sir Charles Gairdner Hospital /ID# 265985
Nedlands, Western Australia, 6009, Australia
University Health Network_Princess Margaret Cancer Centre /ID# 275636
Toronto, Ontario, M5G 2M9, Canada
Jewish General Hospital /ID# 267574
Montreal, Quebec, H3T 1E2, Canada
Chu de Nice-Hopital Larchet Ii /Id# 266845
Nice, Alpes-Maritimes, 06202, France
Hôpital La Timone /ID# 267053
Marseille, Bouches-du-Rhone, 13885, France
Chu De Lille - Hopital Claude Huriez /ID# 270193
Lille, Hauts-de-France, 59037, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694
Tours, Indre-et-Loire, 37000, France
IUCT Oncopole /ID# 266391
Toulouse, Occitanie, 31059, France
Kumamoto University Hospital /ID# 270530
Kumamoto, Kumamoto, 860-8556, Japan
Dokkyo Medical University Hospital /ID# 271648
Mibu, Tochigi, 321-0293, Japan
Nippon Medical School Hospital /ID# 270254
Bunkyo-ku, Tokyo, 113-8603, Japan
The Cancer Institute Hospital Of JFCR /ID# 268342
Koto-ku, Tokyo, 135-8550, Japan
Amsterdam UMC, Location VUmc /ID# 267670
Amsterdam, North Holland, 1081 HV, Netherlands
Universitair Medisch Centrum Utrecht /ID# 267660
Utrecht, 3584 CX, Netherlands
Oslo Universitetssykehus Ulleval /ID# 275433
Oslo, 0450, Norway
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2025
First Posted
March 26, 2025
Study Start
August 7, 2025
Primary Completion (Estimated)
March 1, 2036
Study Completion (Estimated)
March 1, 2036
Last Updated
March 30, 2026
Record last verified: 2026-03
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.