Ph2, Study to Assess the Safety and Efficacy of GPC 100 and Propranolol With and Without G-CSF for the Mobilization of Stem Cells in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
NCT05561751
Age 18 +
Sex Both
Phase Phase 2
Third Opinion Trial Synopsis
This study is testing a new drug called GPC-100. The study will randomly assign patients to two different treatment groups. One group will take GPC-100 and propranolol, and the other group will take GPC-100, propranolol, and another drug called G-CSF. The study will include about 40 patients who will be split evenly between the two groups. The goal of the study is to see how safe and effective GPC-100 is for treating patients. All patients will take 30 mg of propranolol twice a day for 8 days. If needed, they will also take it on the 9th day. Patients will take their first dose at the study site, but will be given doses to take at home for the other times. The study site will check in with patients over the phone to make sure they are taking the propranolol when they are supposed to.
This study is testing a new drug called GPC-100. The study will randomly assign patients to two different treatment groups. One group will take GPC-100 and propranolol, and the other group will take GPC-100, propranolol, and another drug called G-CSF. The study will include about 40 patients who will be split evenly between the two groups. The goal of the study is to see how safe and effective GPC-100 is for treating patients. All patients will take 30 mg of propranolol twice a day for 8 days. If needed, they will also take it on the 9th day. Patients will take their first dose at the study site, but will be given doses to take at home for the other times. The study site will check in with patients over the phone to make sure they are taking the propranolol when they are supposed to.
Third Opinion AI Generated Synopsis
Trial Summary
This is a randomized, open-label study. Patients will be screened within 28 days prior to the study drug administration. Patients will be randomly assigned to 1 of 2 treatment arms prior to study drug administration. Approximately 40 patients will be randomized in a 1:1 ratio to the following treatment arms: * GPC-100 in combination with propranolol; or * GPC-100 in combination with propranolol and G-CSF. To characterize the safety and clinical activity of GPC-100, the study will employ a Bayesian Optimal Phase II (BOP2) design to enroll patients for each arm. All patients will receive via IV 3.14 mg/kg GPC-100 (Burixafor) at least 2 hours prior to leukapheresis sessions from Days 7-8 (Days 9-11 optional) and 30 mg propranolol (3 x 10 mg tablets) twice daily at 8:30 AM (+/- 1 hr) and 4:00 PM (+/- 1 hr) local time from Days 1 to 8 (and on Days 9-11, if applicable). Patients will administer the first dose of propranolol onsite on Day 1. Patients will be provided with doses of propranolol for self-administration at time points when they are not otherwise required to be onsite. Sites should contact patients via telephone to confirm propranolol administration for doses administered outside of clinic.
This is a randomized, open-label study. Patients will be screened within 28 days prior to the study drug administration. Patients will be randomly assigned to 1 of 2 treatment arms prior to study drug administration. Approximately 40 patients will be randomized in a 1:1 ratio to the following treatment arms: * GPC-100 in combination with propranolol; or * GPC-100 in combination with propranolol and G-CSF. To characterize the safety and clinical activity of GPC-100, the study will employ a Bayesian Optimal Phase II (BOP2) design to enroll patients for each arm. All patients will receive via IV 3.14 mg/kg GPC-100 (Burixafor) at least 2 hours prior to leukapheresis sessions from Days 7-8 (Days 9-11 optional) and 30 mg propranolol (3 x 10 mg tablets) twice daily at 8:30 AM (+/- 1 hr) and 4:00 PM (+/- 1 hr) local time from Days 1 to 8 (and on Days 9-11, if applicable). Patients will administer the first dose of propranolol onsite on Day 1. Patients will be provided with doses of propranolol for self-administration at time points when they are not otherwise required to be onsite. Sites should contact patients via telephone to confirm propranolol administration for doses administered outside of clinic.
from ClinicalTrials.gov
Locations & Contact
Fill out the form and to let the Multiple Myeloma Research Foundation know you are interested in this trial.
Contacts:
