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Proteasome Inhibitor
High-Dose Carfilzomib Combo for Multiple Myeloma
Basking Ridge, NJ
Phase 1 & 2
Waitlist Available
Led By Neha Korde, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Agreement by men to use a latex condom during sexual contact with a FCBP
Evidence of underlying end organ damage and/or myeloma defining event
Must not have
Patients receiving >1 cycle of prior treatment or concurrent systemic treatment for multiple myeloma
Specific permitted treatments and washout periods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether carfilzomib, when given in high doses and alongside other drugs, is safe for patients and what the best tolerated dose is. The trial is also testing how much myeloma cells are left in the body after treatment (known as minimal residual disease or MRD).
See full description
Who is the study for?
Adults over 18 with newly diagnosed Multiple Myeloma can join this trial if they have a performance status of 0-2, which means they are fully active or limited in physical activity but able to care for themselves. They must not be pregnant, agree to birth control measures, and meet specific blood count and liver function criteria. Those who've had more than one cycle of treatment for myeloma or have certain health conditions like uncontrolled diabetes or significant heart disease cannot participate.Check my eligibility
What is being tested?
The study is testing high doses of Carfilzomib combined with Lenalidomide and Dexamethasone in patients with new Multiple Myeloma diagnoses. It aims to find the safest high dose level and see how well it reduces myeloma cells (MRD). Patients will receive varying doses to determine the best balance between effectiveness and tolerance.See study design
What are the potential side effects?
Carfilzomib may cause fatigue, nausea, shortness of breath, fever, coughing; Lenalidomide might lead to diarrhea or constipation, muscle cramps; Dexamethasone could result in increased appetite leading to weight gain, difficulty sleeping. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use a latex condom during sex with a female partner.
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Select...
My condition has caused damage to my organs or triggered a significant event.
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Select...
I have been recently diagnosed with multiple myeloma.
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Select...
I can take care of myself and am up and about more than half of my waking hours.
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Select...
I am 18 years old or older.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received more than one cycle of treatment for multiple myeloma.
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Select...
I have followed the required break period after my last treatment.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients with dose limiting toxicity
Side effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
Anaemia
49%
Platelet count decreased
49%
Upper respiratory tract infection
39%
White blood cell count decreased
38%
Hypertension
35%
Hypokalaemia
30%
Neutrophil count decreased
28%
Lymphocyte count decreased
23%
Pneumonia
21%
Cough
19%
Insomnia
19%
Blood creatinine increased
18%
Pyrexia
17%
Diarrhoea
17%
Hyperuricaemia
16%
Neutrophil count increased
16%
Hypocalcaemia
16%
Blood lactate dehydrogenase increased
16%
Hypoalbuminaemia
15%
Blood pressure increased
15%
Blood uric acid increased
15%
Lung infection
14%
White blood cell count increased
14%
Hyperglycaemia
14%
Blood glucose increased
14%
Blood bilirubin increased
14%
Constipation
12%
Neutrophil percentage increased
12%
Blood urea increased
11%
Hypercalcaemia
11%
Alanine aminotransferase increased
11%
Hyponatraemia
10%
Aspartate aminotransferase increased
10%
Productive cough
10%
Blood potassium decreased
10%
Neuropathy peripheral
10%
Oedema peripheral
10%
Bronchitis
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Influenza
8%
Blood albumin decreased
8%
Hypoproteinaemia
8%
Blood phosphorus increased
7%
Hypophosphataemia
7%
Bilirubin conjugated increased
7%
Vomiting
7%
Back pain
7%
Peripheral swelling
7%
Mean cell volume increased
7%
Prealbumin decreased
7%
Abdominal distension
7%
Cataract
7%
Nasopharyngitis
6%
Hepatic function abnormal
6%
Gamma-glutamyltransferase increased
6%
Hypoglycaemia
6%
Respiratory tract infection
6%
Thrombocytopenia
6%
Hyperkalaemia
6%
Nausea
6%
Vision blurred
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Localised infection
2%
Cardiac amyloidosis
1%
Hypotension
1%
Chronic kidney disease
1%
Obstructive airways disorder
1%
Pleural effusion
1%
Interstitial lung disease
1%
Deep vein thrombosis
1%
Myelopathy
1%
Organising pneumonia
1%
Myolipoma
1%
Neuralgia
1%
Asthma
1%
Lipoma
1%
Cerebral ischaemia
1%
Nerve compression
1%
Disease progression
1%
Infusion site extravasation
1%
Escherichia sepsis
1%
Otitis media
1%
Periodontitis
1%
Pathological fracture
1%
Pain
1%
Device related infection
1%
Dysuria
1%
Soft tissue infection
1%
Spinal compression fracture
1%
Cardiac failure acute
1%
Supraventricular tachycardia
1%
Bronchiolitis
1%
Pancreatitis acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Carfilzomib, Lenalidomide, and DexamethasoneExperimental Treatment3 Interventions
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16.
* Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
* Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days
* Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23
* Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Carfilzomib
2017
Completed Phase 3
~1430
Lenalidomide
2005
Completed Phase 3
~2240
Find a Location
Closest Location:Memoral Sloan Kettering Cancer Center· Basking Ridge, NJ
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
600,041 Total Patients Enrolled
87 Trials studying Multiple Myeloma
86,613 Patients Enrolled for Multiple Myeloma
Onyx/AmgenUNKNOWN
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,147 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,769 Patients Enrolled for Multiple Myeloma
Neha Korde, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
165 Total Patients Enrolled
3 Trials studying Multiple Myeloma
165 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use a latex condom during sex with a female partner.I do not have uncontrolled health issues or recent major surgery.My condition has caused damage to my organs or triggered a significant event.You must meet certain requirements for lab tests and medical scans.You have a specific type of disease that can be measured using certain criteria within the last 4 weeks.I am using birth control and have had a recent negative pregnancy test.My blood and liver tests are within normal ranges.I have been recently diagnosed with multiple myeloma.I can take care of myself and am up and about more than half of my waking hours.I have received more than one cycle of treatment for multiple myeloma.I am 18 years old or older.I can safely undergo treatments to prevent blood clots.I have followed the required break period after my last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Carfilzomib, Lenalidomide, and Dexamethasone
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.