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

GPCR Therapeutics, Inc.10 个研究点分布在 1 个国家目标入组 30 人2023年2月13日

概览

简要总结

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.

详细描述

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 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. Only patients randomized to the treatment arm receiving GPC-100 in combination with propranolol and G-CSF will receive SC injections of 10 microgram/kg/day G-CSF at 5:00 PM (+/- 3 hr) local time on Days 3 to 7. Patients in this arm will receive G-CSF injections on Days 8-10 at 5:00 PM (+/- 3 hr) local time only if they will undergo the optional third-fifth days of mobilization/collection (Days 9-11) at the Investigator's 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 3.14 mg/kg dose of GPC-100 free base (active ingredient) and will start collection of CD34+ stem cells via leukapheresis.

注册库

clinicaltrials.gov

开始日期

2023年2月13日

结束日期

2025年10月31日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

GPCR Therapeutics, Inc.

责任方

Sponsor

入排标准

入选标准

•To be eligible to participate in this study, patients must meet all the following criteria:
•Male or female, greater than or equal to18 years of age;
•Patients with diagnosis of MM per the International Myeloma Working Group criteria ;
•Eligible for ASCT at the Investigator's discretion;
•\>4 weeks since completion of last cycle of chemotherapy prior to Day 1;
•Patient must be on first or second complete response or partial response;
•Eastern Cooperative Oncology Group performance status of 0 or 1 (see Appendix C);
•Systolic blood pressure (SBP) 100 - 160 mmHg inclusive, and diastolic blood pressure (DBP) 60 - 100 mmHg inclusive;
•ANC greater than or equal to1.0 x 109/L on Screening laboratory assessments;
•Platelet count greater than or equal to100 x 109/L on Screening laboratory assessments;

排除标准

•Patients must be excluded if they meet any of the following criteria:
•greater than or equal to 25% of BM irradiated within 5 years prior to Day 1 (see Appendix D);
•No more than one year of therapy administered prior to stem cell mobilization, per institution standards;
•Patients who have undergone previous stem cell transplant;
•Receipt of G-CSF within 2 weeks prior to Day 1;
•History of another malignancy except for the following:
•Adequately treated local basal cell or squamous cell carcinoma of the skin;
•Adequately treated carcinoma in situ of the cervix without evidence of disease;
•Adequately treated papillary, noninvasive bladder cancer; or
•Low-grade prostate cancer that is on active surveillance and not expected to clinically progress over 2 years.

研究组 & 干预措施

GPC-100 in combination with propranolol;

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 arm: • GPC-100 in combination with propranolol; or

干预措施: GPC-100

GPC-100 in combination with propranolol;

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 arm: • GPC-100 in combination with propranolol; or

干预措施: Propranolol

GPC-100 in combination with propranolol and G-CSF

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 arm: • GPC-100 in combination with propranolol and G-CSF.

干预措施: GPC-100

GPC-100 in combination with propranolol and G-CSF

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 arm: • GPC-100 in combination with propranolol and G-CSF.

干预措施: Propranolol

GPC-100 in combination with propranolol and G-CSF

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 arm: • GPC-100 in combination with propranolol and G-CSF.

干预措施: G-CSF