Clinical trial NCT06896916: 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
Official title: Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Cereblon E3 Ligase Modulatory Drug
CELMoD
Iberdomide
Etentamig
ABBV-383
Lead sponsor: TeneoOne Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

* 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

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).

Primary outcomes:
measure: Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
timeFrame: Up to Approximately 56 Days
measure: Number of Participants with Adverse Events (AE)s
timeFrame: Up to Approximately 129 Months
Secondary outcomes:
measure: Partial Response (PR) Response Rate (RR)
timeFrame: Up to 3 Years
measure: Very Good Partial Response (VGPR) RR
timeFrame: Up to 3 Years
measure: Complete Response (CR) RR
timeFrame: Up to 3 Years
measure: Stringent Complete Response (sCR) RR
timeFrame: Up to 3 Years
measure: Overall Response Rate (ORR)
timeFrame: Up to 3 Years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 3 Years
measure: Duration of Response (DOR)
timeFrame: Up to 3 Years
measure: Time-to-Progression (TTP)
timeFrame: Up to 3 Years
measure: Minimal Residual Disease (MRD) negativity
timeFrame: Up to 3 Years
Other outcomes:
Locations:
Study officials:
affiliation: TeneoOne Inc.
name: TeneoOne Inc
role: STUDY_DIRECTOR
References: