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

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.