Study on the Safety and Effects of ABBV-453 Alone or with Other Myeloma Treatments in Adults with Multiple Myeloma
Sponsor: AbbVie
ClinicalTrials ID:NCT06953960
This clinical trial is testing a new drug, ABBV-453, to see if it is safe and effective in treating adults with multiple myeloma that has returned or not responded to previous treatments. The study will involve different combinations of ABBV-453 with other myeloma drugs.
Patient Parameters
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Program Overview
Multiple myeloma is a type of cancer that affects certain cells in the bone marrow. This study aims to evaluate the safety and effectiveness of a new drug called ABBV-453 in adults with multiple myeloma that has come back or is not responding to treatment. Participants will receive ABBV-453 either alone or in combination with other drugs like daratumumab, dexamethasone, and pomalidomide. The study will take place over approximately 4.5 years and involve about 130 participants worldwide. Participants will have regular check-ups, including medical assessments and blood tests, to monitor the treatment's effects and any side effects.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of multiple myeloma based on standard criteria.
- Have measurable disease, which means certain levels of specific proteins in the blood or urine.
- Have not been treated with BCL-2 inhibitors before.
- Have specific genetic markers (t(11;14) positive and/or high BCL2 status).
- For Substudy 1 Dose Escalation and Substudy 2: Must have been treated with three types of myeloma drugs and have had 3 to 5 previous treatments, with no other suitable treatment options.
- For Substudy 1 Dose Expansion: Must have been treated with two types of myeloma drugs and have had 1 to 3 previous treatments.
Exclusion Criteria
- Have had major surgery within 4 weeks before starting the study or plan to have major surgery during the study.
- Have active infections or recent infections that required treatment within 7 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Southern California /ID# 272414 | 90033 | Los Angeles | California |
| Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214 | 10065 | New York | New York |
| University of North Carolina at Chapel Hill /ID# 272454 | 27514 | Chapel Hill | North Carolina |
| Northwest Medical Specialties Tacoma /ID# 272506 | 98405 | Tacoma | Washington |
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