A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
Reason given: Study closed due to portfolio prioritization
Key facts
- Where
- Aurora, Austin, Eugene, Fairfax, Iowa City, Miami, New York, Palo Alto, Rochester, Seattle, St Louis, Tyler, and Westwood, United StatesSee the 13 sites
- Phase
- Phase 1
Where in United States
- Rocky Mountain Cancer Centers-AuroraAurora, United StatesNo longer taking part
- Texas Oncology-Austin MidtownAustin, United StatesNo longer taking part
- Willamette Valley Cancer Institute and Research CenterEugene, United StatesNo longer taking part
- Virginia Cancer Specialists PCFairfax, United StatesNo longer taking part
- Holden Comprehensive Cancer Center - University of IowaIowa City, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- Weill Cornell MedicineNew York, United StatesNo longer taking part
- Stanford University, School of MedicinePalo Alto, United StatesNo longer taking part
- James P. Wilmot Cancer Center / University of Rochester Medical CenterRochester, United StatesNo longer taking part
- Fred Hutchinson Cancer Research CenterSeattle, United StatesNo longer taking part
- Washington University in St. LouisSt Louis, United StatesNo longer taking part
- Texas Oncology - Northeast TexasTyler, United StatesNo longer taking part
- University of Kansas Cancer CenterWestwood, United StatesNo longer taking part
Trial details
- Who runs it
- Seagen Inc.
- Trial code
- NCT03582033
- Record updated
- 24 December 2024
- Original description
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.Read full original descriptionShow less
A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory 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 several parts. In Parts A and B, 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 Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.
Inclusion: Histologically confirmed diagnosis of MM; Must have MM that is relapsed or refractory; Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody; 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 (FLC) 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda FLC ratio; Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1; Life expectancy of greater than 3 months in the opinion of the investigator; Adequate hematologic, renal, and hepatic function.
Exclusion: Parts A and D: Prior treatment with a BCMA-directed therapy; 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; Combination therapy only:; Known intolerance to corticosteroids; Uncontrolled psychoses; History of another malignancy within 3 years; Active cerebral or meningeal disease related to the underlying malignancy; Uncontrolled Grade 3 or higher infection.