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
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 details:
B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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).
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06896916
Intervention or treatment
DRUG: Etentamig
DRUG: Iberdomide
Conditions
- Multiple Myeloma
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Research sites nearby
Closest Location:
Blacktown Hospital /ID# 265983
Select from list below to view details:
Blacktown Hospital /ID# 265983
Blacktown, New South Wales, Australia
Wollongong Hospital /ID# 265625
Wollongong, New South Wales, Australia
Austin Hospital /ID# 265984
Melbourne, Victoria, Australia
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Who is running the clinical trial?
AbbVie
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Phase 1: ABBV-383 Dose Escalation
| Drug: Etentamig, Drug: Iberdomide |
EXPERIMENTAL: Phase 2: ABBV-383 Dose Expansion Dose A
| Drug: Etentamig, Drug: Iberdomide |
EXPERIMENTAL: Phase 2: ABBV-383 Dose Expansion Dose B
| Drug: Etentamig, Drug: Iberdomide |
What is the study measuring?
Primary Outcome
| 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
| 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 |
References
Clinical Trials Gov: 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 MyelomaOther trials to consider
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