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NCT05561751 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by GPCR Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT05561751 is a Phase 2 study that has completed, run by GPCR Therapeutics. The registered enrollment target is 30 participants.
The verdict
NCT05561751, a Phase 2 study, has completed, sponsored by GPCR Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG G-CSF
- DRUG Propranolol
- DRUG GPC-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-02-13 |
| Est. Completion | 2025-10-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05561751
The ClinicalTrials.gov registry entry for NCT05561751 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GPCR Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which G-CSF is the first listed.
NCT05561751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05561751 about?
NCT05561751 is a clinical study titled "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". 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 treat...
What is the current status of trial NCT05561751?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2023-02-13. Estimated completion is 2025-10-31.
What interventions are being tested in trial NCT05561751?
The interventions under investigation include: G-CSF (DRUG), Propranolol (DRUG), GPC-100 (DRUG).
Who is sponsoring clinical trial NCT05561751?
This trial is sponsored by GPCR Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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