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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Etentamig; Drug: Iberdomide

Detailed Description

B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Recruiting
      • Blacktown Hospital /ID# 265983
    • Wollongong, New South Wales, Australia, 2500
      • Recruiting
      • Wollongong Hospital /ID# 265625
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Recruiting
      • Austin Hospital /ID# 265984
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital /ID# 265981
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Sir Charles Gairdner Hospital /ID# 265985
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network_Princess Margaret Cancer Centre /ID# 275636
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital /ID# 267574
• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Recruiting
      • Chu de Nice-Hopital Larchet Ii /Id# 266845
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13885
      • Recruiting
      • Hôpital La Timone /ID# 267053
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59037
      • Recruiting
      • Chu De Lille - Hopital Claude Huriez /ID# 270193
  • Indre-et-Loire
    • Tours, Indre-et-Loire, France, 37000
      • Recruiting
      • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694
  • Occitanie
    • Toulouse, Occitanie, France, 31059
      • Recruiting
      • IUCT Oncopole /ID# 266391
      • Contact: Site Coordinator; Phone Number: 05 31 15 50 50
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East /ID# 268343
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 860-8556
      • Recruiting
      • Kumamoto University Hospital /ID# 270530
  • Tochigi
    • Mibu, Tochigi, Japan, 321-0293
      • Recruiting
      • Dokkyo Medical University Hospital /ID# 271648
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Recruiting
      • Nippon Medical School Hospital /ID# 270254
    • Koto-ku, Tokyo, Japan, 135-8550
      • Recruiting
      • The Cancer Institute Hospital Of JFCR /ID# 268342
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • Universitair Medisch Centrum Utrecht /ID# 267660
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1081 HV
      • Recruiting
      • Amsterdam UMC, Location VUmc /ID# 267670
• Norway
  • Oslo, Norway, 0450
    • Recruiting
    • Oslo Universitetssykehus Ulleval /ID# 275433
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Recruiting
      • Beverly Hills Cancer Center /ID# 266921
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Colorado Blood Cancer Institute /ID# 273751
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University /ID# 266972
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of New Jersey /ID# 266833
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282
  • North Carolina
    • Hillsborough, North Carolina, United States, 27278
      • Recruiting
      • University Of North Carolina Health Care - Hillsborough Campus /ID# 278230
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Swedish Medical Center - Seattle /ID# 268052

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Etentamig; Intravenous (IV) Infusion; Drug: Iberdomide; Oral Capsule
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.	Drug: Etentamig; Intravenous (IV) Infusion; Drug: Iberdomide; Oral Capsule
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.	Drug: Etentamig; Intravenous (IV) Infusion; Drug: Iberdomide; Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial Response (PR) Response Rate (RR)	PR is defined >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hours, if the serum and urine M-protein are unmeasurable, a >= 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, if the serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a >= 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >= 30%, >= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline.	Up to 3 Years
Very Good Partial Response (VGPR) RR	VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein < 100 mg per 24 hours, for participants in whom the only measurable disease is by serum free light chains (FLC) levels, VGPR is defined as >= 90% decrease in the difference between involved and uninvolved FLC levels.	Up to 3 Years
Complete Response (CR) RR	CR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, < 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio is also required.	Up to 3 Years
Stringent Complete Response (sCR) RR	sCR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, < 5% plasma cells in bone marrow, normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry (kappa/lambda ratio <= 4:1 or >= 1:2 for kappa and lambda participants, respectively, after counting >= 100 plasma cells).	Up to 3 Years
Overall Response Rate (ORR)	ORR (PR + VGPR + CR + sCR) will be defined as the proportion of participants who achieved a PR or better.	Up to 3 Years
Progression-Free Survival (PFS)	PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.	Up to 3 Years
Duration of Response (DOR)	DOR is defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first.	Up to 3 Years
Time-to-Progression (TTP)	TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression.	Up to 3 Years
Minimal Residual Disease (MRD) negativity	The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status.	Up to 3 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2025
• Primary Completion (Estimated): March 1, 2036
• Study Completion (Estimated): March 1, 2036

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Iberdomide; CELMoD; ABBV-383; Etentamig; Cereblon E3 Ligase Modulatory Drug
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; iberdomide
• Other Study ID Numbers: M24-555; 2024-512146-41-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes