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

Running, not enrolling · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06223516

Run by

AbbVie

People needed

60

Starts

2024-06-17

Expected to finish

2027-12-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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