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Proteasome Inhibitor
Telaglenastat + Carfilzomib + Dexamethasone for Multiple Myeloma
Phase 1
Waitlist Available
Led By Wilson I Gonsalves
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Patients must have relapsed and/or refractory myeloma and be experiencing disease relapse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial will test the combination of CB-839 HCl, carfilzomib, and dexamethasone to treat patients with multiple myeloma that has come back or does not respond to previous treatment.
Who is the study for?
This trial is for adults with multiple myeloma that has returned or isn't responding to treatment. They must have had at least two prior treatments, including a proteasome inhibitor and an immunomodulatory drug. Participants need adequate blood counts, organ function, and agree to use effective contraception. Those who can't join include those intolerant to carfilzomib, on other trials, with uncontrolled illnesses, pregnant or nursing women, and those with certain medical conditions.Check my eligibility
What is being tested?
The trial tests the best dose of CB-839 HCl combined with carfilzomib and dexamethasone in patients whose multiple myeloma has relapsed or is refractory. The goal is to find out if this combination can better halt cancer growth by blocking enzymes needed for cell growth compared to current treatments.See study design
What are the potential side effects?
Potential side effects may include fatigue; increased risk of infection; changes in blood pressure; nausea; vomiting; diarrhea; liver enzyme changes suggesting liver damage; allergic reactions similar to past allergies participants might have had related drugs being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but may not be able to do heavy physical work.
Select...
My myeloma has returned or is not responding to treatment.
Select...
I have had at least two treatments for my condition, including a PI, an IMiD, and an anti-CD38 antibody.
Select...
My kidney function is within the normal range or my GFR is at least 40.
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My white blood cell count is healthy without needing medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) and recommended phase II dose (RP2D)
Secondary outcome measures
Incidence of adverse events
Overall response rate (ORR)
Other outcome measures
Pharmacokinetic (PK) profiles and pharmacodynamic effect
Side effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
Anaemia
49%
Upper respiratory tract infection
49%
Platelet count decreased
39%
White blood cell count decreased
38%
Hypertension
35%
Hypokalaemia
30%
Neutrophil count decreased
28%
Lymphocyte count decreased
23%
Pneumonia
21%
Cough
19%
Blood creatinine increased
19%
Insomnia
18%
Pyrexia
17%
Hyperuricaemia
17%
Diarrhoea
16%
Hypoalbuminaemia
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Blood lactate dehydrogenase increased
15%
Blood uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
Hyperglycaemia
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Alanine aminotransferase increased
11%
Hyponatraemia
11%
Hypercalcaemia
10%
Aspartate aminotransferase increased
10%
Blood potassium decreased
10%
Bronchitis
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood phosphorus increased
8%
Influenza
8%
Blood albumin decreased
8%
Hypoproteinaemia
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Peripheral swelling
7%
Nasopharyngitis
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Thrombocytopenia
6%
Vision blurred
6%
Respiratory tract infection
6%
Hepatic function abnormal
6%
Nausea
6%
Hypoglycaemia
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Cardiac amyloidosis
2%
Localised infection
1%
Pain
1%
Periodontitis
1%
Myelopathy
1%
Device related infection
1%
Dysuria
1%
Pleural effusion
1%
Otitis media
1%
Pancreatitis acute
1%
Spinal compression fracture
1%
Lipoma
1%
Cerebral ischaemia
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Soft tissue infection
1%
Nerve compression
1%
Chronic kidney disease
1%
Hypotension
1%
Asthma
1%
Bronchiolitis
1%
Pathological fracture
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CB-839 HCI, dexamethasone, carfilzomib)Experimental Treatment3 Interventions
Patients receive glutaminase inhibitor CB-839 Patients receive glutaminase inhibitor CB-839 hydrochloride PO every 12 hours on days 1-28, dexamethasone PO on days 1, 2, 8, 9, 15, 16, and 23, and carfilzomib IV over 10 minutes on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Carfilzomib
2017
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,845 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,095 Patients Enrolled for Multiple Myeloma
Wilson I GonsalvesPrincipal InvestigatorMayo Clinic Cancer Center LAO
3 Previous Clinical Trials
106 Total Patients Enrolled
3 Trials studying Multiple Myeloma
106 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a stomach or intestine condition that affects how I absorb pills.I cannot tolerate or did not respond to carfilzomib treatment.I am willing to have a bone marrow test during the study.My cancer has spread to my brain or spinal cord.I am allergic to medications similar to CB-839 HCl, carfilzomib, or dexamethasone.I have been diagnosed with AL amyloidosis.Your hemoglobin level is at least 8 grams per deciliter within 14 days before joining the study.I have recovered from side effects of previous cancer treatments, except for mild nerve issues.I can take care of myself but may not be able to do heavy physical work.I am currently taking medication for HIV.I have not had major surgery in the last 14 days.You must have at least 3,000 white blood cells per microliter of blood.Your platelet count is at least 50,000 cells per cubic millimeter. If your bone marrow plasma cells are 50% or higher, then your platelet count should be at least 30,000 cells per cubic millimeter.My myeloma has returned or is not responding to treatment.I have had at least two treatments for my condition, including a PI, an IMiD, and an anti-CD38 antibody.My kidney function is within the normal range or my GFR is at least 40.I do not have any unmanaged ongoing illnesses.My white blood cell count is healthy without needing medication.I do not have a recent serious heart condition or uncontrolled heart rhythm problems.I agree to use birth control during and for 4 months after treatment.Your total bilirubin level is less than or equal to 1.5 times the upper limit of normal.I have severe nerve damage in my hands or feet, or moderate with pain.Your AST and ALT levels in your blood should be no more than three times the normal limit at the hospital where you are being treated.I am not taking high doses of corticosteroids outside my treatment plan.I haven't had or been treated for another cancer within the last 2 years.I am currently breastfeeding.I haven't taken strong chemotherapy drugs, steroids, or antibody treatments in the last 2 weeks.Women who can have babies need to have a recent negative pregnancy test before joining the study.Patients must have a measurable amount of myeloma according to specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CB-839 HCI, dexamethasone, carfilzomib)
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.
To what degree is Carfilzomib safe for patients to use?
"Carfilzomib's safety is assessed as a 1 due to its Phase 1 status, suggesting that there are limited findings on both efficacy and security."
Answered by AI
What medical conditions does Carfilzomib typically address?
"Carfilzomib is the preferred treatment for ophthalmia, sympathetic. It can also help manage symptoms of communicable diseases and retinal conditions such as branch retinal vein occlusion and macular edema."
Answered by AI
Are there any other investigations concerning the efficacy of Carfilzomib?
"Carfilzomib was initially examined in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Up until now, a total of 1147 studies have been finalized and there are currently 570 active clinical trials occurring across various locations such as Columbus, Ohio."
Answered by AI
Are there any opportunities for individuals to enroll in this research endeavor?
"This research initiative is not currently enrolling participants. Initially posted on December 26th, 2018 and last updated September 16th 2022, this trial has since been closed to any new applicants. For those looking for other studies, there are 807 separate trials actively searching for patients with multiple myeloma and 570 clinical trials requiring Carfilzomib that need volunteers."
Answered by AI
What is the current enrollment capacity of this research project?
"At present, the trial is not accepting patients. It was uploaded on December 26th 2018 and last modified on September 16th 2022. If you are looking for alternative studies, 807 trials recruiting multiple myeloma sufferers and 570 Carfilzomib trials currently have open enrolment programs."
Answered by AI
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