A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur. The study will have two parts. In the first part, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works. In the second part of the study, participants will be given both SEA-BCMA and dexamethasone. Dexamethasone is a drug that can be used to treat multiple myeloma. The part will study whether SEA-BCMA and dexamethasone are safe when used together.
- Multiple Myeloma
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Histologically confirmed diagnosis of multiple myeloma (MM)
- Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
- Must have MM that is relapsed or refractory and must not have other therapeutic options available known to provide clinical benefit in MM
- Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
- Life expectancy of greater than 3 months in the opinion of the investigator
- Patients of childbearing potential or who can father children must agree to consistently use 2 effective forms of birth control for at least 6 months after the final dose of study drug administration
- Adequate hematologic, renal, and hepatic function
- Measurable disease, as defined by at least one of the following: (1) serum M protein 0.5 g/dL or higher, (2) urine M protein 200 mg/24 hour or higher, and (3) serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- Prior treatment with a BCMA-directed therapy
- History of another malignancy within 3 years
- Active cerebral or meningeal disease related to the underlying malignancy
- Uncontrolled Grade 3 or higher infection
- Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.
- Patients who are pregnant or breastfeeding
- Combination therapy only:
- Known intolerance to corticosteroids
- Uncontrolled psychoses
- Phase 1
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
|SEA-BCMA + dexamethasone||
- Seattle Genetics, Inc.
Study ContactSeattle Genetics Trial Information Support