NCT06223516Active, not recruitingPhase 1
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 · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 17 Jan 2024
- Start date
- 17 Jun 2024
- Primary completion date
- Feb 2027
- Lead sponsor
- AbbVie
- Diseases
- Multiple myeloma
- NCT number
- NCT06223516
- EU CT number
- 2023-507901-32-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 60
- From 17 Jun 2024 to the primary completion date, Feb 2027
- 20 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Withdrawn |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Withdrawn |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Withdrawn |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Withdrawn |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Withdrawn |
| Institut Universitaire du Cancer Toulouse - Oncopole Coordinator of this site? Confirm its status | Toulouse | France | Withdrawn |
| Hadassah Medical Center-Hebrew University /ID# 261446 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 261699 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 261525 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Kindai University Hospital /ID# 266016 Coordinator of this site? Confirm its status | Sakai-shi | Japan | Unknown status |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050 Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Mayo Clinic Hospital Jacksonville /ID# 262808 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Sylvester Comprehensive Cancer Center /ID# 260798 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Wisconsin Medical Center /ID# 261085 Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Mayo Clinic Arizona /ID# 260799 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Mayo Clinic - Rochester /ID# 262807 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Atrium Health Wake Forest Baptist Medical Center /ID# 260807 Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.