A Phase 1 interventional study of Etentamig in Relapsed/Refractory Multiple Myeloma, sponsored by AbbVie. Active, not recruiting at 6 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
Multiple myeloma (MM) is an incurable disease characterized by the growth of monoclonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease state of etentamig in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.
Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Two doses of ABBV-383 will be explored. Each treatment arm receives a different dose of ABBV-383 to determine a tolerable dose. Approximately 12 adult participants with R/R MM will be enrolled in the study in approximately 6 sites in Japan.
Participants will receive intravenous (IV) Etentamig (ABBV-383) at two increasing doses in 21-day cycles.
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, and and monitoring of side effects.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 8 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Must have a confirmed diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working group (IMWG) criteria.
Must have measurable disease within 28 days of enrollment, defined as at least 1 of the following:
Exclusion Criteria:
- Has received B-cell maturation antigen (BCMA)-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive Etentamig Dose A in 21-day cycles.
Drug: Etentamig
Participants with R/R MM who meet the criteria outline in the protocol will receive Etentamig Dose B in 21-day cycles.
Drug: Etentamig
Intravenous (IV) Infusion
Number of Dose-Limiting Toxicities (DLT)
DLT events are defined as adverse events or abnormal laboratory values assessed as "reasonable possibility" of relationship to the administration of Etentamig, which cannot be attributed by the investigator to a clearly identifiable cause such as disease progression or concurrent illness.
Time frame: Up to Approximately 12 Months
Number of Participants with Adverse Events (AE)
AE 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.
Time frame: Up to Approximately 24 Months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieve confirmed partial response (PR) or better determined by International Myeloma Working Group (IMWG) criteria, prior to the initiation of subsequent myeloma therapy.
Time frame: Up to Approximately 24 Months
Progression Free Survival (PFS)
PFS is defined as the duration from the date of first dose to the date of disease progression (PD) determined by IMWG criteria, or death, whichever occurs first.
Time frame: Up to Approximately 24 Months
Time to Response (TTR)
TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by investigator.
Time frame: Up to Approximately 24 Months
Duration of Response (DOR)
DOR is defined as the number of days from the day the response criteria are met to the date that disease progression is objectively documented.
Time frame: Up to Approximately 24 Months
Minimal Residual Disease (MRD) Negativity Rate
MRD is defined as the percentage of participants with assessment of the minimal residual disease negativity.
Time frame: Up to Approximately 24 Months
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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