A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Launched by TENEOONE INC. · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ABBV-383 for adults with relapsed or refractory multiple myeloma, a type of blood cancer. Multiple myeloma occurs when plasma cells in the blood grow uncontrollably, often causing problems like bone pain and infections. The trial will look at how safe ABBV-383 is and whether it helps improve symptoms in patients whose cancer has returned or hasn’t responded well to previous treatments. About 180 adults will participate, and they will receive the medication as an infusion into a vein over 28-day cycles for up to three years.

To be eligible for the trial, participants must have measurable disease and have already received multiple lines of treatment for their cancer. Depending on the specific group they join in the study, there are different requirements regarding past therapies they must have received. Participants can expect regular hospital visits for assessments, blood tests, and to monitor for any side effects during the trial. It's important to note that this trial might involve a more intensive treatment schedule than standard care, but it aims to explore a promising new option for those with challenging cases of multiple myeloma.

Gender

ALL

Eligibility criteria

• 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.

Trial Officials