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

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.

Timeline

Start

2023-02-13

Primary completion

2025-09-30

Completion

2025-10-31

Publications

• Sukhtankar DD, Fung JJ, Kim MN, Cayton T, Chiou V, Caculitan NG, Zalicki P, Kim S, Jo Y, Kim S, Lee JM, Choi J, Mun S, Chin A, Jang Y, Lee JY, Kim G, Kim EH, Huh WK, Jeong JY, Seen DS, Cardarelli PM. GPC-100, a novel CXCR4 antagonist, improves in vivo hematopoietic cell mobilization when combined with propranolol. PLoS One. 2023 Oct 25;18(10):e0287863. doi: 10.1371/journal.pone.0287863. eCollection 2023.

Drugs

Indications