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

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT05561751
Run by: GPCR Therapeutics, Inc.
People needed: 30
Starts: 2023-02-13
Expected to finish: 2025-10-31
Last updated by the study team: 2026-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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;
Creatinine clearance greater than or equal to 30 ml/min, as calculated according to the Cockcroft-Gault formula;
Aspartate aminotransferase and alanine aminotransferase less than or equal to 2 x upper limit of normal (ULN) and total bilirubin less than or equal to1.5 x ULN on Screening laboratory assessments;
Adequate cardiac (left ventricular ejection fraction [LVEF] greater than or equal to 50%) and pulmonary function (room air O2 saturation value greater than or equal to 92%);
For females, 1 of the following criteria must be fulfilled:
At least 1 year postmenopausal; or
Surgically sterile, or willing to use a double-barrier method of contraception (e.g., intrauterine device plus condom, spermicidal gel plus condom) from Day 1 until 28 days after the last dose of GPC-100.
Males must be willing to use a reliable form of contraception (e.g., use of a condom or a partner fulfilling the above criteria) from Day 1 until 28 days after the last dose of GPC-100; and
Patients must be willing and able to provide signed informed consent. 4.2 Exclusion Criteria
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;

Where it is running

University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla, California, United States
University of Florida (UF) - Shands Cancer Center — Gainesville, Florida, United States
Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States
University of Massachusetts — Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
John Theurer Cancer Center At Hackensack UMC — Hackensack, New Jersey, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States
The Cleveland Clinic Foundation — Cleveland, Ohio, United States
MD Anderson Cancer Center — Houston, Texas, United States
Virginia Commonwealth University - Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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