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GPC-100 + Propranolol for Multiple Myeloma

Phase 2

Recruiting

Research Sponsored by GPCR Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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%)

>4 weeks since completion of last cycle of chemotherapy prior to Day 1

Must not have

Receipt of prior treatment with CXCR4 inhibitor for stem cell collection

History of long QT syndrome or torsade de pointes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a drug to treat 40 people. They'll get propranolol and some will get a second drug as well. The study will measure the safety and effectiveness of the drug.

Who is the study for?

Adults diagnosed with Multiple Myeloma eligible for stem cell transplant, not on their first or second response to treatment. They must have normal organ function, blood pressure within specific limits, and agree to use contraception. Excluded are those with certain heart conditions, active infections, previous transplants, recent investigational drug use, severe asthma requiring beta agonists, or a positive COVID-19 test.

What is being tested?

The trial is testing the safety and effectiveness of GPC-100 combined with propranolol versus adding G-CSF to this combination in mobilizing stem cells for transplantation in Multiple Myeloma patients. It's randomized and open-label with two arms receiving different treatments.

What are the potential side effects?

Potential side effects may include reactions at the infusion site from IV drugs; low blood pressure due to propranolol; bone pain or headache from G-CSF; and possible changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart and lungs are functioning well.

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It has been over 4 weeks since my last chemotherapy session.

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I have been diagnosed with multiple myeloma.

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I am fully active or can carry out light work.

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My cancer has partially or completely responded to treatment once or twice.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously received a CXCR4 inhibitor for stem cell collection.

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I have a history of long QT syndrome or torsade de pointes.

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I have severe asthma and need beta agonist therapy.

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I have not received G-CSF treatment in the last 2 weeks.

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More than 25% of my bone marrow was irradiated in the last 5 years.

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I've had less than a year of treatment before stem cell collection.

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I have had a stem cell transplant in the past.

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I am on beta-blockers and cannot change my medication.

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I have a history of serious heart or lung conditions.

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I have not been treated for an infection in the last 7 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients that achieve >=2 x 10^6 CD34+ cells/kg in 2 leukapheresis sessions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: GPC-100 in combination with propranolol;Experimental Treatment2 Interventions

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

Group II: GPC-100 in combination with propranolol and G-CSFExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propranolol

2010

Completed Phase 4

~1290

G-CSF

2014

Completed Phase 4