M24-108: Phase 1b, Open-label Study with ABBV-383 in Relapsed/Refractory Multiple Myeloma
Research type
Research Study
Full title
A Multicentre, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of ABBV-383 in Subjects with Relapsed or Refractory Multiple Myeloma
IRAS ID
1006892
Contact name
Aleksandra Jankielewicz
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2022-502399-21
Clinicaltrials.gov Identifier
Research summary
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 includes 2 parts; step-up dose optimisation (Part 1) and dose expansion (Part 2). In Part 1, different levels 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 will be used followed by the target dose of ABBV-383. Around 80 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world.
Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0084
Date of REC Opinion
22 Sep 2023
REC opinion
Further Information Favourable Opinion