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A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of ABBV-383 in Subjects With Relapsed or Refractory Multiple Myeloma
Description
Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). 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 adverse events and change in disease symptoms 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 Multiple Myeloma (MM). This study is broken into 3 Arms; Arm A (Parts 1 and 2), Arm B and Arm C. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat
Trial Eligibility
Inclusion Criteria: * Must have measurable disease as outlined in the protocol. * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C only: ECOG performance of \<= 1. * 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) 2016 criteria. * Must be naïve to treatment with ABBV-383. * Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody. * Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA). * Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of ABBV-383. Exclusion Criteria: * Arm A: Received BCMA-targeted therapy. * Arm C: Rapidly progressing disease per investigator.
Study Info
Organization
TeneoOne Inc.
Primary Outcome
Arm A (Part 1 and Part 2) and Arm C: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events
Interventions
Locations Recruiting
Mayo Clinic Arizona /ID# 251405
United States, Arizona, Phoenix
Highlands Oncology Group - Springdale /ID# 267742
United States, Arkansas, Springdale
Medical Oncology Hematology Consultants /ID# 268560
United States, Delaware, Newark
Hope And Healing Cancer Services /ID# 268536
United States, Illinois, Hinsdale
Fort Wayne Medical Oncology And Hematology /ID# 268179
United States, Indiana, Fort Wayne
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