Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 135
- Locations
- 49
- Primary Endpoint
- Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eastern Cooperative Oncology Group (ECOG) performance of 0 or
- •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).
Arms & Interventions
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.
Intervention: Etentamig (Drug)
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.
Intervention: Etentamig (Drug)
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.
Intervention: Iberdomide (Drug)
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.
Intervention: Etentamig (Drug)
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.
Intervention: Iberdomide (Drug)
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.
Intervention: Iberdomide (Drug)
Outcomes
Primary Outcomes
Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
Time Frame: Up to Approximately 56 Days
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.
Number of Participants with Adverse Events (AE)s
Time Frame: Up to Approximately 129 Months
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.
Secondary Outcomes
- Time-to-Progression (TTP)(Up to 3 Years)
- 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)
- Progression-Free Survival (PFS)(Up to 3 Years)
- Duration of Response (DOR)(Up to 3 Years)
- Minimal Residual Disease (MRD) negativity(Up to 3 Years)