Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05561751
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2022-09-26
Brief Title:
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
Sponsor:
GPCR Therapeutics Inc
Organization:
GPCR Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Randomized Open-Label 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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 314 mgkg 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 830 AM - 1 hr and 400 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
Approximately 40 patients will be randomized in a 11 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 314 mgkg 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 830 AM - 1 hr and 400 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
Detailed Description:
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 11 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 via IV 314 mgkg 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 830 AM - 1 hr and 400 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
Only patients randomized to the treatment arm receiving GPC-100 in combination with propranolol and G-CSF will receive SC injections of 10 microgramkgday G-CSF at 500 PM - 3 hr local time on Days 3 to 7 Patients in this arm will receive G-CSF injections on Days 8-10 at 500 PM - 3 hr local time only if they will undergo the optional third-fifth days of mobilizationcollection Days 9-11 at the Investigators discretion
On Days 7 and 8 and on Days 9-11 if applicable the patient will receive a morning 30 mg propranolol dose 3 x 10 mg tablets followed immediately by a 314 mgkg dose of GPC-100 free base active ingredient and will start collection of CD34 stem cells via leukapheresis
Approximately 40 patients will be randomized in a 11 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 via IV 314 mgkg 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 830 AM - 1 hr and 400 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
Only patients randomized to the treatment arm receiving GPC-100 in combination with propranolol and G-CSF will receive SC injections of 10 microgramkgday G-CSF at 500 PM - 3 hr local time on Days 3 to 7 Patients in this arm will receive G-CSF injections on Days 8-10 at 500 PM - 3 hr local time only if they will undergo the optional third-fifth days of mobilizationcollection Days 9-11 at the Investigators discretion
On Days 7 and 8 and on Days 9-11 if applicable the patient will receive a morning 30 mg propranolol dose 3 x 10 mg tablets followed immediately by a 314 mgkg dose of GPC-100 free base active ingredient and will start collection of CD34 stem cells via leukapheresis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None