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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
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

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Goethe University Frankfurt
Coordinator of this site? Confirm its status
Frankfurt Am MainGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyActive, not recruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
CreteilFranceWithdrawn
Centre Hospitalier Universitaire De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceWithdrawn
Centre Hospitalier Universitaire de Nantes
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NantesFranceWithdrawn
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
Pierre-BéniteFranceWithdrawn
Centre Hospitalier Universitaire de Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceWithdrawn
Institut Universitaire du Cancer Toulouse - Oncopole
Coordinator of this site? Confirm its status
ToulouseFranceWithdrawn
Hadassah Medical Center-Hebrew University /ID# 261446
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
The Chaim Sheba Medical Center /ID# 261699
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Ramat GanIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 261525
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Tel AvivIsraelUnknown status
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286
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NagoyaJapanUnknown status
Kindai University Hospital /ID# 266016
Coordinator of this site? Confirm its status
Sakai-shiJapanUnknown status
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050
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Ann ArborUnited StatesUnknown status
Mayo Clinic Hospital Jacksonville /ID# 262808
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JacksonvilleUnited StatesUnknown status
Sylvester Comprehensive Cancer Center /ID# 260798
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MiamiUnited StatesUnknown status
Wisconsin Medical Center /ID# 261085
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MilwaukeeUnited StatesUnknown status
Mayo Clinic Arizona /ID# 260799
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PhoenixUnited StatesUnknown status
Mayo Clinic - Rochester /ID# 262807
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Atrium Health Wake Forest Baptist Medical Center /ID# 260807
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.