Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma

Last updated: March 26, 2026
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Cancer/tumors

Multiple Myeloma

Treatment

Intravenous (IV) Etentamig

Subcutaneous (SC) ABBV-383

Subcutaneous (SC) Etentamig

Clinical Study ID

NCT06223516
M23-001
2023-507901-32-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2.

  • Participants with relapsed or refractory multiple myeloma who have received 3-5prior lines of therapies and with prior triple class exposure including a proteasomeinhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug.

  • Must be naïve to treatment with ABBV-383.

Exclusion

Exclusion Criteria:

  • Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Study Design

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: Intravenous (IV) Etentamig
Phase: 1
Study Start date:
June 17, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Universitaetsklinikum Frankfurt /ID# 260442

    Frankfurt am Main, Hesse 60590
    Germany

    Site Not Available

  • Universitaetsklinikum Frankfurt /ID# 260442

    Frankfurt am Main 2925533, Hesse 2905330 60590
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln /ID# 260445

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln /ID# 260445

    Cologne, North Rhine-Westphalia 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln /ID# 260445

    Cologne 2886242, North Rhine-Westphalia 2861876 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 260444

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 260444

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 261446

    Jerusalem, Jerusalem 91120
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 261446

    Jerusalem 281184, Jerusalem 293198 91120
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 261699

    Ramat Gan, Tel Aviv 5265601
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 261525

    Tel Aviv, Tel Aviv 6423906
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 261699

    Ramat Gan 293788, Tel Aviv 293396 5265601
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 261525

    Tel Aviv 293397, Tel Aviv 293396 6423906
    Israel

    Site Not Available

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286

    Nagoya, Aichi-ken 466-8650
    Japan

    Site Not Available

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286

    Nagoya 1856057, Aichi-ken 1865694 466-8650
    Japan

    Site Not Available

  • Kindai University Hospital /ID# 266016

    Osaka sayama-shi, Osaka 589-8511
    Japan

    Site Not Available

  • Kindai University Hospital /ID# 266016

    Osakasayama-shi, Osaka 589-8511
    Japan

    Site Not Available

  • Kindai University Hospital /ID# 266016

    Sakai-shi, Osaka 590-0197
    Japan

    Site Not Available

  • Mayo Clinic Arizona /ID# 260799

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Mayo Clinic Arizona /ID# 260799

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Site Not Available

  • Mayo Clinic /ID# 262808

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Mayo Clinic Hospital Jacksonville /ID# 262808

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center /ID# 260798

    Miami, Florida 33136-1002
    United States

    Site Not Available

  • Mayo Clinic Hospital Jacksonville /ID# 262808

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center /ID# 260798

    Miami 4164138, Florida 4155751 33136-1002
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Mayo Clinic - Rochester /ID# 262807

    Rochester, Minnesota 55905-0001
    United States

    Site Not Available

  • Mayo Clinic - Rochester /ID# 262807

    Rochester 5043473, Minnesota 5037779 55905-0001
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist Medical Center /ID# 260807

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist Medical Center /ID# 260807

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Site Not Available

  • Wisconsin Medical Center /ID# 261085

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Wisconsin Medical Center /ID# 261085

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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