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
NCT05055063
Age 18 +
Sex Both
Phase Phase 1
Third Opinion Trial Synopsis
Doctors are doing a study to see if a drug called Belantamab Mafodotin is safe and what the best dose is for people with a type of blood cancer called high-risk smoldering multiple myeloma. The study will have two parts: one to try different doses and one to give more people the best dose. They will only include 30 patients in the study. They will check if the drug works by seeing how many people's cancer gets better. They won't be stopping the study early if it's not working well because there aren't enough people in the second part.
Doctors are doing a study to see if a drug called Belantamab Mafodotin is safe and what the best dose is for people with a type of blood cancer called high-risk smoldering multiple myeloma. The study will have two parts: one to try different doses and one to give more people the best dose. They will only include 30 patients in the study. They will check if the drug works by seeing how many people's cancer gets better. They won't be stopping the study early if it's not working well because there aren't enough people in the second part.
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.
from ClinicalTrials.gov
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