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Proteasome Inhibitor
Carfilzomib + Pomalidomide + Dexamethasone for Multiple Myeloma
Phase 2
Waitlist Available
Led By Ajay Nooka, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide through 90 days after the last dose of study drug
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose until documented progression or death, assessed at 18 months
Awards & highlights
Study Summary
This trial will study how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma.
Who is the study for?
This trial is for adults with high-risk multiple myeloma who've possibly had a stem cell transplant and responded to treatment. They must be able to follow the study plan, use effective birth control, and not have other serious health issues or recent major surgeries. People with certain heart conditions, infections like HIV or hepatitis B/C, previous cancers (except some skin/cervical), allergies to study drugs, or poor reaction to steroids can't join.Check my eligibility
What is being tested?
The trial tests a combination of three drugs: Carfilzomib (blocks enzymes needed for cancer cells growth), Pomalidomide and Dexamethasone (both chemotherapy agents that kill or stop cancer cells from growing). It aims to see if this mix works better for those with aggressive multiple myeloma.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, risk of infection due to low blood counts, allergic reactions to the medication components, potential heart complications related to Carfilzomib usage, nerve damage symptoms like numbness or tingling sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am committed to using two forms of birth control before, during, and after taking pomalidomide.
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I am fully active or can carry out light work.
Select...
I am a woman capable of becoming pregnant.
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I had a stem cell transplant within a year of my diagnosis and my condition has partially improved.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose until documented progression or death, assessed at 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose until documented progression or death, assessed at 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
≥ Complete response (CR) rates
Secondary outcome measures
Best response on-study
Duration of response (DOR)
Minimal residual disease (MRD) detection
+3 moreSide 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: Carfilzomib, pomalidomide, dexamethasoneExperimental Treatment3 Interventions
Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. 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
FDA approved
Pomalidomide
FDA approved
Carfilzomib
FDA approved
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,550 Total Patients Enrolled
16 Trials studying Multiple Myeloma
907 Patients Enrolled for Multiple Myeloma
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,544 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,949 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,659 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,711 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is low, with a creatinine clearance under 30 mL/min.Your platelet count is less than 75,000 cells/mm³ when checked at the screening evaluation.I have known serious heart problems.I have had a stroke or brain injury that still affects me.You have had a bad reaction to steroid medication in the past.I had major surgery less than 4 weeks ago or am still dealing with its side effects.I am currently pregnant or breastfeeding.I do not have any serious illnesses like uncontrolled diabetes or active infections.I cannot take certain blood thinners due to allergies or side effects.Your liver enzyme levels are more than three times the normal limit within 21 days before starting the treatment.I am committed to using two forms of birth control before, during, and after taking pomalidomide.Patients with a disease that is considered to have a high chance of causing serious health problems based on specific criteria.Your body has very low levels of a type of white blood cells called neutrophils.I have been diagnosed with a specific blood or bone marrow condition.I am fully active or can carry out light work.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that didn't spread.Your bilirubin level is higher than the normal range allowed by the hospital within 21 days before starting the treatment.I am currently undergoing or have previously had treatment for myeloma.I have a known brain or spinal cord condition.Your hemoglobin level is less than 8.0 g/dL when screened.I am at high risk and did not reach partial remission after my stem cell transplant.I agree to use a condom during sex for 90 days after my last dose.I will not donate sperm for 3 months after my last dose of carfilzomib or pomalidomide.I am allergic or react badly to the study drugs or similar medications.I have tested negative for pregnancy before starting pomalidomide.I agree not to donate blood during and for 3 months after treatment.I have moderate to severe nerve damage in my hands or feet.I am a woman capable of becoming pregnant.I had a stem cell transplant within a year of my diagnosis and my condition has partially improved.
Research Study Groups:
This trial has the following groups:- Group 1: Carfilzomib, pomalidomide, dexamethasone
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Could you please explain the Carfilzomib patient safety record?
"Carfilzomib has undergone some testing for safety, but there is no evidence yet that it is an effective treatment. Our team rates it as a 2."
Answered by AI
How many people are being studied in this experiment at most?
"As of now, this clinical trial is no longer looking for patients that meet the study's eligibility criteria. This trial was first posted on 1/25/2019. The latest update to the study was on 10/11/2022. There are 838 other active trials for multiple myeloma and 604 for Carfilzomib."
Answered by AI
Carfilzomib is usually given to patients with what condition?
"Carfilzomib is a medication typically used to treat ophthalmia and sympathetic. However, it has also shown to be effective in managing branch retinal vein occlusion, macular edema, and communicable diseases."
Answered by AI
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