A Phase 1 interventional study of Etentamig and Dexamethasone in Relapsed/Refractory Multiple Myeloma, sponsored by AbbVie. Active, not recruiting at 49 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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 safety and toxicity of etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), or daratumumab-dexamethasone (Dd), in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity 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. Etentamig co-administered with Pd, Rd, or Dd, will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of etentamig, followed by a dose expansion phase to confirm the dose. Approximately 320 adult participants with R/R MM will be enrolled in the study in approximately 48 sites worldwide.
Participants will receive intravenous (IV) etentamig co-administered with oral/IV Pd, oral/IV Rd, or oral/IV/subcutaneous (SC) Dd in 28-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, questionnaires and side effects.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 283 is above 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.
Exclusion Criteria:
Has any of the following conditions:
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.
Drug: Etentamig · Drug: Dexamethasone · Drug: Pomalidomide
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.
Drug: Etentamig · Drug: Dexamethasone · Drug: Lenalidomide
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
Drug: Etentamig · Drug: Dexamethasone · Drug: Daratumumab
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.
Drug: Etentamig · Drug: Dexamethasone · Drug: Pomalidomide
Intravenous (IV) Infusion
Also known as: ABBV-383
Oral; Tablet or IV Infusion
Oral; Capsule
Oral; Capsule
Subcutaneous Injection (SC)
Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig
DLT events as described in the protocol will be assessed.
Time frame: Up to approximately 28 Days
Number of Participants with Adverse Events (AEs)
An 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. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to Approximately 3 Years
Overall Response Rate (ORR)
ORR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better.
Time frame: Up to Approximately 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.
Time frame: Up to Approximately 3 Years
Duration of Response (DOR)
DOR will be 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.
Time frame: Up to Approximately 3 Years
Time-to-Progression (TTP)
TTP is defined as the number of days from the date of first dose to the date of earliest disease progression.
Time frame: Up to Approximately 3 Years
Percentage of Participants with Minimal Residual Diseas (MRD) Negativity by Next-Generation Sequencing (NGS)
MRD negative status (threshold as assessed by NGS Adaptive Clonoseq) with \>= CR (per International Myeloma Working Group \[IMWG\] response criteria) prior to the initiation of new myeloma therapy.
Time frame: Up to Approximately 3 Years
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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