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

Plain Language Summary

Simplified for easier understanding

This study is testing a new form (subcutaneous injection under the skin) of a drug called ABBV-383 in people with multiple myeloma (a blood cancer) that has returned or stopped responding to prior treatments. **You may be eligible if...** - You have been diagnosed with multiple myeloma that has relapsed or is no longer responding to treatment - You have received between 3 and 5 prior treatment regimens - Your prior treatment included at least one drug from three key classes: a proteasome inhibitor, an anti-CD38 antibody, and an immunomodulatory drug - You have not previously been treated with ABBV-383 - Your overall health status is adequate (ECOG 2 or below) **You may NOT be eligible if...** - You have previously received a bispecific antibody targeting BCMA and CD3 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Universitaetsklinikum Frankfurt /ID# 260442

Frankfurt am Main, Hesse, Germany

The Chaim Sheba Medical Center /ID# 261699

Ramat Gan, Tel Aviv, Israel

Kindai University Hospital /ID# 266016

Sakai-shi, Osaka, Japan

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

Nagoya, Aichi-ken, Japan

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

Ann Arbor, Michigan, United States

Sylvester Comprehensive Cancer Center /ID# 260798

Miami, Florida, United States

Tel Aviv Sourasky Medical Center /ID# 261525

Tel Aviv, Tel Aviv, Israel

Wisconsin Medical Center /ID# 261085

Milwaukee, Wisconsin, United States

Atrium Health Wake Forest Baptist Medical Center /ID# 260807

Winston-Salem, North Carolina, United States

Mayo Clinic - Rochester /ID# 262807

Rochester, Minnesota, United States

Universitaetsklinikum Koeln /ID# 260445

Cologne, North Rhine-Westphalia, Germany

Hadassah Medical Center-Hebrew University /ID# 261446

Jerusalem, Jerusalem, Israel

Universitaetsklinikum Hamburg-Eppendorf /ID# 260444

Hamburg, Germany

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NCT06223516


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