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A Multicenter, Phase 1b, Open-label Study of ABBV-383 Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma


Description

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 inj

Trial Eligibility

Inclusion Criteria: * 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 Criteria: - Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Study Info

Organization

AbbVie


Primary Outcome

Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events


Outcome Timeframe Up to 2 cycles (56 days)

NCTID NCT06223516

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2024-06-17

Completion Date 2027-02-21

Enrollment Target 55

Interventions

DRUG Subcutaneous (SC) ABBV-383

DRUG Intravenous (IV) ABBV-383

Locations Recruiting

Atrium Health Wake Forest Baptist Medical Center /ID# 260807

United States, North Carolina, Winston-Salem


Universitaetsklinikum Hamburg-Eppendorf /ID# 260444

Germany, Hamburg


The Chaim Sheba Medical Center /ID# 261699

Israel, Tel-Aviv, Ramat Gan


Tel Aviv Sourasky Medical Center /ID# 261525

Israel, Tel-Aviv, Tel Aviv


Hadassah Medical Center-Hebrew University /ID# 261446

Israel, Yerushalayim, Jerusalem


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