Multiple MyelomaPhase 2NCT05561751
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 testing GPC-100, Propranolol and G-CSF in people with Multiple Myeloma, run by GPCR Therapeutics, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- GPC-100, Propranolol and G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Feb 2023to 31 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 39Show fewer
- 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;
- 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.
- Patients who are on BBs and unable to switch therapy; Note: Patients on BBs who are able to switch therapy will undergo a gradual tapering of their current BB under the guidance of the Investigator. At the Investigator's discretion, the initial days of propranolol administration may be permitted to overlap with the final days of tapering of the previous BB. Patients may not be treated with cardiovascular drugs that would interact with propranolol including angiotensin-converting enzyme (ACE) inhibitors, calcium channel blockers, and alpha blockers at study enrollment and while on propranolol during the study.
- Patients with severe asthma who require beta agonist therapy;
- History of poor and uncontrolled cardiovascular or pulmonary disease such as myocardial infarction, cardiac arrhythmias, transient ischemic attack, congestive heart failure (New York Heart Association heart failure class >2), stroke, unexplained syncope, or chronic obstructive pulmonary disease;
- History of long QT syndrome or torsade de pointes;
- Patients with a QTcF >470 msec or PR interval >280 msec on Screening 12-lead electrocardiogram (ECG);
- Active infection requiring treatment in the 7 days before Day 1;
- Positive polymerase chain reaction test from nasal specimen for SARS-CoV-2 within 7 days prior to Day 1;
- Pregnant or breastfeeding;
- Known psychiatric or substance abuse disorder that would interfere with Protocol compliance;
- Receipt of any other investigational drug or device within 1 month before Day 1; or
- Receipt of prior treatment with CXCR4 inhibitor for stem cell collection.
Who cannot join
None listed.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Florida (UF) - Shands Cancer Center
Gainesville, Florida, 32608
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, 07601
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46077
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, 92037
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23284
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: 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
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- GPC-100, Propranolol, G-CSF
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPC-100Drug
GPC-100 is to be administered at a dose of 3.14 mg/kg GPC-100 free base via IV infusion. The corresponding volume of the reconstituted GPC-100 solution calculated based on the patient weight will be administered via IV infusion over 15 min
PropranololDrug
propranolol
G-CSFDrug
G-CSF
| Study group | Role | What they receive |
|---|---|---|
| GPC-100 in combination with propranolol; | Experimental | 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 Receives: Drug: GPC-100; Drug: Propranolol |
| GPC-100 in combination with propranolol and G-CSF | Experimental | 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. Receives: Drug: GPC-100; Drug: Propranolol; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that achieve >=2 x 10^6 CD34+ cells/kg in 2 leukapheresis sessions
Determine the proportion of patients that will achieve >=2 x 10^6 CD34+ cells/kg in 2 leukapheresis sessions following treatment
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start13 Feb 2023
- Primary completion30 Sep 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GPCR Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561751
- Sponsor's protocol ID
- GPC-100-001
- Status last verified
- Feb 2026
- First submitted
- 26 Sep 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37878624
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05561751
- Acronym / sponsor ID
- GPC-100-001
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GPCR Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GPC-100 in combination with propranolol; | Experimental | Drug: GPC-100, Drug: PropranololPatients 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 |
| GPC-100 in combination with propranolol and G-CSF | Experimental | Drug: GPC-100, Drug: Propranolol, Drug: G-CSFPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPC-100GPC-100 is to be administered at a dose of 3.14 mg/kg GPC-100 free base via IV infusion. The corresponding volume of the reconstituted GPC-100 solution calculated based on the patient weight will be administered via IV infusion over 15 min | Drug | GPC-100 in combination with propranolol and G-CSF, GPC-100 in combination with propranolol; |
| Propranololpropranolol | Drug | GPC-100 in combination with propranolol and G-CSF, GPC-100 in combination with propranolol; |
| G-CSFG-CSF | Drug | GPC-100 in combination with propranolol and G-CSF |
Primary outcome
Proportion of patients that achieve >=2 x 10^6 CD34+ cells/kg in 2 leukapheresis sessions
Time frame: 2 days
Determine the proportion of patients that will achieve >=2 x 10^6 CD34+ cells/kg in 2 leukapheresis sessions following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Derived from this study: PubMed 37878624Sukhtankar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GPC-100, Propranolol and G-CSF in people with Multiple Myeloma, run by GPCR Therapeutics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that achieve >=2 x 10^6 CD34+ cells/kg in 2 leukapheresis sessions (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.