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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: Completed Phase 2 study, sponsored by GPCR Therapeutics.
NCT05561751 is a Phase 2 study that has completed, run by GPCR Therapeutics. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine the proportion of patients that will achieve \>=2 x 10\^6 CD34+ cells/kg in 2 leukapheresis sessions following treatment
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 |
What the finished NCT05561751 record still lists
NCT05561751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which G-CSF is the first listed.
NCT05561751 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05561751's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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