Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group (ECOG) performance of 0 to 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

Locations
United States
Colorado
Colorado Blood Cancer Institute /ID# 273751
RECRUITING
Denver
Missouri
Washington University /ID# 266972
RECRUITING
St Louis
New Jersey
Rutgers Cancer Institute of New Jersey /ID# 266833
RECRUITING
New Brunswick
Other Locations
Australia
Blacktown Hospital /ID# 265983
RECRUITING
Blacktown
Austin Hospital /ID# 265984
RECRUITING
Melbourne
Wollongong Hospital /ID# 265625
RECRUITING
Wollongong
France
IUCT Oncopole /ID# 266391
RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694
RECRUITING
Tours
Japan
Nippon Medical School Hospital /ID# 270254
RECRUITING
Bunkyo-ku
The Cancer Institute Hospital Of JFCR /ID# 268342
RECRUITING
Koto-ku
Kumamoto University Hospital /ID# 270530
RECRUITING
Kumamoto
Dokkyo Medical University Hospital /ID# 271648
RECRUITING
Mibu
Netherlands
Universitair Medisch Centrum Utrecht /ID# 267660
RECRUITING
Utrecht
Norway
Oslo Universitetssykehus Ulleval /ID# 275433
RECRUITING
Oslo
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2036-03
Participants
Target number of participants: 135
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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