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

Purpose

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.

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Beverly Hills Cancer Center /ID# 266921
Beverly Hills, California 90211

Colorado Blood Cancer Institute /ID# 273751
Denver, Colorado 80218

Washington University /ID# 266972
St Louis, Missouri 63110

Rutgers Cancer Institute of New Jersey /ID# 266833
New Brunswick, New Jersey 08901

Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282
New York, New York 10065

University Of North Carolina Health Care - Hillsborough Campus /ID# 278230
Hillsborough, North Carolina 27278

Swedish Medical Center - Seattle /ID# 268052
Seattle, Washington 98104

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Detailed Description

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