RecruitingPhase 1NCT06223516

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


Sponsor

AbbVie

Enrollment

55 participants

Start Date

Jun 17, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria1

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

Interventions

DRUGSubcutaneous (SC) Etentamig

SC Injection

DRUGIntravenous (IV) Etentamig

IV Infusion


Locations(15)

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

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NCT06223516


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