Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT06223516
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
55 participants
INTERVENTIONAL
2024-06-17
2027-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Etentamig Dose A
Participants will receive Dose A of Etentamig as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.
Subcutaneous (SC) Etentamig
SC Injection
Intravenous (IV) Etentamig
IV Infusion
Etentamig Dose B
Participants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration.
Subcutaneous (SC) Etentamig
SC Injection
Intravenous (IV) Etentamig
IV Infusion
Etentamig Expansion
Participants will receive the selected dose from Arm A of Etentamig as SC injections, during the 151 week study duration.
Subcutaneous (SC) Etentamig
SC Injection
Interventions
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Subcutaneous (SC) Etentamig
SC Injection
Intravenous (IV) Etentamig
IV Infusion
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Mayo Clinic Arizona /ID# 260799
Phoenix, Arizona, United States
Mayo Clinic Hospital Jacksonville /ID# 262808
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center /ID# 260798
Miami, Florida, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester /ID# 262807
Rochester, Minnesota, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 260807
Winston-Salem, North Carolina, United States
Wisconsin Medical Center /ID# 261085
Milwaukee, Wisconsin, United States
Universitaetsklinikum Frankfurt /ID# 260442
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Koeln /ID# 260445
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 260444
Hamburg, , Germany
Hadassah Medical Center-Hebrew University /ID# 261446
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 261699
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 261525
Tel Aviv, Tel Aviv, Israel
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286
Nagoya, Aichi-ken, Japan
Kindai University Hospital /ID# 266016
Sakai-shi, Osaka, Japan
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2023-507901-32-00
Identifier Type: OTHER
Identifier Source: secondary_id
M23-001
Identifier Type: -
Identifier Source: org_study_id
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