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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The PK profile of GPC-100 of PK parameter Cmax
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
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.
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
~1610
Find a Location
Who is running the clinical trial?
GPCR Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
107 Total Patients Enrolled
3 Trials studying Multiple Myeloma
43 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of long QT syndrome or torsade de pointes.I have severe asthma and need beta agonist therapy.I have not received G-CSF treatment in the last 2 weeks.My doctor thinks I am a good candidate for a stem cell transplant.Your white blood cell count is at least 1.0 x 10^9/L.Your liver enzymes and bilirubin levels are within a certain range on the lab tests before the study.More than 25% of my bone marrow was irradiated in the last 5 years.I am a woman who is either postmenopausal, surgically sterile, or willing to use reliable contraception.I have a history of serious heart or lung conditions.I agree to use effective birth control during and for 28 days after the last dose of GPC-100.Your heart's electrical activity, as measured by an ECG, shows specific irregularities.My heart and lungs are functioning well.I've had less than a year of treatment before stem cell collection.I am on beta-blockers and cannot change my medication.I have previously received a CXCR4 inhibitor for stem cell collection.I have had a stem cell transplant in the past.I have had cancer before, but it was either skin cancer treated successfully, cervical cancer without current signs, noninvasive bladder cancer treated well, or low-grade prostate cancer not expected to worsen soon.It has been over 4 weeks since my last chemotherapy session.Your kidneys work well enough to filter out waste from your blood.I have not been treated for an infection in the last 7 days.You have tested positive for COVID-19 within 7 days before the start of the study.I am 18 years old or older.Your blood pressure should be between 100/60 and 160/100.I have been diagnosed with multiple myeloma.Your platelet count is 100 or more on the screening test.I am fully active or can carry out light work.My cancer has partially or completely responded to treatment once or twice.
Research Study Groups:
This trial has the following groups:- Group 1: GPC-100 in combination with propranolol;
- Group 2: GPC-100 in combination with propranolol and G-CSF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is GPC-100 a viable option when prescribed alongside propranolol for human consumption?
"Assessed on a 1 to 3 scale, GPC-100 and propranolol are estimated to be moderately safe due to the available Phase 2 trial data which has verified safety but not efficacy."
Answered by AI
What is the overall population size of individuals enrolled in this clinical investigation?
"Affirmative. Information present on clinicaltrials.gov reveals that this medical experiment, which launched on February 13th 2023, is currently recruiting participants. 40 volunteers will be accepted between a single site."
Answered by AI
Is there currently a call for participants in this research?
"Based on the clinicaltrials.gov page, this research initiative is actively seeking participants as of writing. It was originally posted on February 13th 2023 and underwent its most recent update a day later."
Answered by AI
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