Study Comparing ABBV-383 Infusion to Standard Treatments for Adults with Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: AbbVie
ClinicalTrials ID:NCT06158841
This clinical trial is testing a new drug, ABBV-383, to see if it can better manage symptoms of multiple myeloma that has returned or is not responding to treatment, compared to standard therapies.
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Program Overview
Multiple myeloma is a type of blood cancer that affects plasma cells, often found in bones and bone marrow. It can cause bone pain, fractures, infections, and kidney problems. This study is testing a new drug, ABBV-383, to see if it can help adults with multiple myeloma that has come back or isn't responding to treatment. Participants will be divided into two groups: one will receive ABBV-383, and the other will receive standard treatments chosen by their doctor. The study will last about 3.5 years and involve around 380 participants worldwide.
Eligibility Criteria
Inclusion Criteria
- Must be able to perform daily activities with some limitations (ECOG score of 0 to 2).
- Diagnosed with multiple myeloma that has returned or is not responding to treatment.
- Must have measurable signs of the disease, such as specific levels of proteins in the blood or urine.
- Must have tried at least two different treatments before, including specific types of drugs.
- Must not have received treatments targeting a specific protein called BCMA.
- Must be eligible for standard treatments based on medical guidelines and past treatment history.
Exclusion Criteria
- Significant drug or alcohol abuse in the past 6 months.
- Serious health conditions affecting the brain, mental health, hormones, metabolism, immune system, heart, lungs, or liver in the past 6 months that could interfere with the study.
- Cancer affecting the brain or spinal cord.
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