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: April 14, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Bone Neoplasm

Red Blood Cell Disorders

Lymphoproliferative Disorders

Treatment

Subcutaneous (SC) ABBV-383

Intravenous (IV) ABBV-383

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 ABBV-383 in adult participants with relapsed/refractory (R/R) MM.

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 25 sites across the world

In Arm A participants will receive one of two doses of 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: 55
Treatment Group(s): 2
Primary Treatment: Subcutaneous (SC) ABBV-383
Phase: 1
Study Start date:
June 17, 2024
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Universitaetsklinikum Frankfurt /ID# 260442

    Frankfurt am Main, Hessen 60590
    Germany

    Active - Recruiting

  • Universitaetsklinikum Koeln /ID# 260445

    Köln, Nordrhein-Westfalen 50937
    Germany

    Active - Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 260444

    Hamburg, 20246
    Germany

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 261699

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 261525

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 261446

    Jerusalem, Yerushalayim 91120
    Israel

    Active - Recruiting

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

    Nagoya, Aichi 466-8650
    Japan

    Active - Recruiting

  • Kindai University Hospital /ID# 266016

    Osakasayama-shi, Osaka 589-8511
    Japan

    Active - Recruiting

  • Mayo Clinic Arizona /ID# 260799

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Mayo Clinic /ID# 262808

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center /ID# 260798

    Miami, Florida 33136-1002
    United States

    Active - Recruiting

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

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester /ID# 262807

    Rochester, Minnesota 55905-0001
    United States

    Active - Recruiting

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

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Wisconsin Medical Center /ID# 261085

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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