A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma
Summary
Third Opinion Trial Synopsis:
This is a medical study to see if a new treatment called Belantamab Mafodotin is safe for people with a certain kind of cancer called high-risk smoldering multiple myeloma. The study will have two parts: one to find the right dose and one to test it on more people. The study will involve up to 30 patients, with 18 in the first part and 12 in the second part. They will check if the treatment works at the end of the study. Because there aren't many patients in the second part, they won't have a strict rule for checking if it works.
This is a medical study to see if a new treatment called Belantamab Mafodotin is safe for people with a certain kind of cancer called high-risk smoldering multiple myeloma. The study will have two parts: one to find the right dose and one to test it on more people. The study will involve up to 30 patients, with 18 in the first part and 12 in the second part. They will check if the treatment works at the end of the study. Because there aren't many patients in the second part, they won't have a strict rule for checking if it works.
*Third Opinion AI Generated Synopsis
Trial Summary
This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion part. The maximum number of enrolled patients will be 30 with 18 patients for the dose-finding part and 12 patients for the dose-expansion part. Once we determine the MTD or RP2D in the dose-finding part, we will enroll and treat 12 additional patients at the MTD or RP2D in the expansion part. Efficacy will be assessed through the overall response rate (ORR) at the end of the study. With the limited number of patients for the dose-expansion part, we will not have formal futility monitoring rule.
This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion part. The maximum number of enrolled patients will be 30 with 18 patients for the dose-finding part and 12 patients for the dose-expansion part. Once we determine the MTD or RP2D in the dose-finding part, we will enroll and treat 12 additional patients at the MTD or RP2D in the expansion part. Efficacy will be assessed through the overall response rate (ORR) at the end of the study. With the limited number of patients for the dose-expansion part, we will not have formal futility monitoring rule.
Locations & Contact
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Contacts:
