A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma ABBV-383

What's the purpose of this trial?

The purpose of this study is to assess the safety and toxicity of ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult patients with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
  • Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
  • Must have measurable disease as outlined in the protocol.
  • Must be naïve to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
  • Has received prior MM treatment in Arms A, B, C, and D.

Exclusion Criteria:

  • Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment.
  • Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
  • Known central nervous system involvement Multiple Myeloma (MM).
  • Has any of the following conditions:
    • Nonsecretory MM.
    • Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9L circulating plasma cells by standard differential.
    • Waldenstrom's macroglobulinemia.
    • Light chain amyloidosis.
    • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
    • Major surgery within 4 weeks prior to first dose or planned study participation.
    • Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal or antiviral).
    • Uncontrolled diabetes or hypertension within 14 days prior to first dose.
    • Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.
  • Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.

Additional Trial Information

Phase 1

Enrollment: 270 patients (estimated)

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Trial Locations

All Trial Locations

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Arkansas

University of Arkansas for Medical Sciences (UAMS)

Little Rock, AR

Not Yet Accepting

Florida

Sylvester Comprehensive Cancer Center University of Miami Health System

Miami, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Not Yet Accepting

Massachusetts

University of Massachusetts Medical School

Worcester, MA

Not Yet Accepting

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Not Yet Accepting

Montana

Bozeman Deaconess Hospital

Bozeman, MT

Not Yet Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Not Yet Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Not Yet Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Not Yet Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Not Yet Accepting

Washington

University of Washington School of Medicine

Seattle, WA

Not Yet Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting
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