Clinical trial · Interventional
Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma
A Multicenter, Phase 1b, Open-label Study of Etentamig (ABBV-383) Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of Etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 15 sites across the world In Arm A participants will receive one of two doses of Etentamig (ABBV-383) as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous (IV) Etentamig | Drug | — | UNRESOLVED |
| Subcutaneous (SC) Etentamig | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Etentamig Dose A
- description
- Participants will receive Dose A of Etentamig as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.
- interventionNames
- Drug: Subcutaneous (SC) Etentamig
- Drug: Intravenous (IV) Etentamig
- type
- EXPERIMENTAL
- label
- Etentamig Dose B
- description
- Participants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration.
- interventionNames
- Drug: Subcutaneous (SC) Etentamig
- Drug: Intravenous (IV) Etentamig
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. * Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug. * Must be naïve to treatment with ABBV-383. Exclusion Criteria: \- Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
References
Publications (0)
Data not yet available