New drug combo aims to boost stem cell harvest for myeloma patients
NCT ID NCT05561751
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 study tests whether a new drug called GPC-100, combined with propranolol and with or without G-CSF, can effectively mobilize stem cells in people with multiple myeloma who are preparing for an autologous stem cell transplant. The goal is to see if enough stem cells can be collected in just two sessions. The trial enrolled 30 adults who were eligible for transplant and had achieved at least a partial response to prior therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GPC-100 (burixafor) combined with propranolol, with or without G-CSF
- What this could lead to
- If successful, this could improve stem cell collection for multiple myeloma patients undergoing transplant, making the process more efficient and reducing the need for additional sessions.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to all patients. The combination may not work better than current methods, and side effects from the drugs are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria To be eligible to participate in this study, patients must meet all the following criteria: 1. Male or female, greater than or equal to18 years of age; 2. Patients with diagnosis of MM per the International Myeloma Working Group criteria ; 3. Eligible for ASCT at the Investigator's discretion; 4. \>4 weeks since completion of last cycle of chemotherapy prior to Day 1; 5. Patient must be on first or second complete response or partial response; 6. Eastern Cooperative Oncology Group performance status of 0 or 1 (see Appendix C); 7. Systolic blood pressure (SBP) 100 - 160 mmHg inclusive, and diastolic blood pressure (DBP) 60 - 100 mmHg inclusive; 8. ANC greater than or equal to1.0 x 109/L on Screening laboratory assessments; 9. Platelet count greater than or equal to100 x 109/L on Screening laboratory assessments; 10. Creatinine clearance greater than or equal to 30 ml/min, as calculated according to the Cockcroft-Gault formula; 11. 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; 12. 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%); 13. For females, 1 of the following criteria must be fulfilled: 1. At least 1 year postmenopausal; or 2. 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. 14. 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 15. 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: 1. greater than or equal to 25% of BM irradiated within 5 years prior to Day 1 (see Appendix D); 2. No more than one year of therapy administered prior to stem cell mobilization, per institution standards; 3. Patients who have undergone previous stem cell transplant; 4. Receipt of G-CSF within 2 weeks prior to Day 1; 5. History of another malignancy except for the following: 1. Adequately treated local basal cell or squamous cell carcinoma of the skin; 2. Adequately treated carcinoma in situ of the cervix without evidence of disease; 3. Adequately treated papillary, noninvasive bladder cancer; or 4. Low-grade prostate cancer that is on active surveillance and not expected to clinically progress over 2 years. 6. 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. 7. Patients with severe asthma who require beta agonist therapy; 8. 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; 9. History of long QT syndrome or torsade de pointes; 10. Patients with a QTcF \>470 msec or PR interval \>280 msec on Screening 12-lead electrocardiogram (ECG); 11. Active infection requiring treatment in the 7 days before Day 1; 12. Positive polymerase chain reaction test from nasal specimen for SARS-CoV-2 within 7 days prior to Day 1; 13. Pregnant or breastfeeding; 14. Known psychiatric or substance abuse disorder that would interfere with Protocol compliance; 15. Receipt of any other investigational drug or device within 1 month before Day 1; or 16. Receipt of prior treatment with CXCR4 inhibitor for stem cell collection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
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Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46077, United States
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John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, 07601, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, 92037, United States
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University of Florida (UF) - Shands Cancer Center
Gainesville, Florida, 32608, United States
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University of Massachusetts
Worcester, Massachusetts, 01655, United States
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Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23284, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A "Physician & patient-powered" cohort registry
- A phase i study to evaluate the safety and immunogenicity of 3D189 in patients with hematologic malignancies
- Daratumumab, pomalidomide and dexamethasone for Del(17p) positive relapsed and Relapsed/Refractory multiple myeloma patients [DEDALO]
- Can a Four-Drug cocktail tackle Hard-to-Treat myeloma spread?
- Can a protein boost immune recovery after myeloma transplant?
- Can compassion meditation ease the emotional toll of stem cell transplants?