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Proteasome Inhibitor

High-Dose Carfilzomib Combo for Multiple Myeloma

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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).

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 below
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I agree to use a latex condom during sex with a female partner.
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My condition has caused damage to my organs or triggered a significant event.
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I am using birth control and have had a recent negative pregnancy test.
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My blood and liver tests are within normal ranges.
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I have been recently diagnosed with multiple myeloma.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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I can safely undergo treatments to prevent blood clots.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with dose limiting toxicity

Side effects data

From 2021 Phase 3 trial • 126 Patients • NCT03029234
62%
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%
Blood creatinine increased
19%
Insomnia
18%
Pyrexia
17%
Diarrhoea
17%
Hyperuricaemia
16%
Blood lactate dehydrogenase increased
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Hypoalbuminaemia
15%
Blood pressure increased
15%
Blood uric acid increased
15%
Lung infection
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
14%
Hyperglycaemia
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Hyponatraemia
11%
Alanine aminotransferase increased
11%
Hypercalcaemia
10%
Blood potassium decreased
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Bronchitis
10%
Aspartate aminotransferase increased
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood albumin decreased
8%
Blood phosphorus increased
8%
Hypoproteinaemia
8%
Influenza
7%
Prealbumin decreased
7%
Peripheral swelling
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Nasopharyngitis
7%
Bilirubin conjugated increased
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Thrombocytopenia
6%
Vision blurred
6%
Nausea
6%
Hepatic function abnormal
6%
Respiratory tract infection
6%
Hyperkalaemia
6%
Hypoglycaemia
3%
Acute kidney injury
3%
Plasma cell myeloma
2%
Bone pain
2%
Localised infection
2%
Cardiac amyloidosis
1%
Pathological fracture
1%
Dysuria
1%
Hypotension
1%
Cardiac failure acute
1%
Spinal compression fracture
1%
Lipoma
1%
Periodontitis
1%
Asthma
1%
Deep vein thrombosis
1%
Myelopathy
1%
Chronic kidney disease
1%
Nerve compression
1%
Otitis media
1%
Soft tissue infection
1%
Cerebral ischaemia
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Pleural effusion
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
1%
Pain
1%
Bronchiolitis
1%
Device related infection
1%
Pancreatitis acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone

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
~2590
Carfilzomib
2017
Completed Phase 3
~1440
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,771 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,130 Patients Enrolled for Multiple Myeloma
Onyx/AmgenUNKNOWN
CelgeneIndustry Sponsor
632 Previous Clinical Trials
127,883 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,826 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02937571 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Carfilzomib, Lenalidomide, and Dexamethasone
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT02937571 — Phase 1 & 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02937571 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been other scientific investigations concerning Carfilzomib?

"At present, 705 ongoing studies are utilizing Carfilzomib with 167 of them being in their final phase. Most experiments occur near Joliet, Illinois but there are 25 542 other sites also conducting trials on the drug."

Answered by AI

To what maladies is Carfilzomib typically administered?

"Carfilzomib is usually used to treat ophthalmic and sympathetic disorders. Furthermore, this medication has been proven effective against various other illnesses such as branch retinal vein occlusion, macular edema and diseases requiring a minimum of two prior systemic chemotherapy regimens."

Answered by AI

What is the current size of the participant pool for this experiment?

"At this moment, applications are not being accepted for this clinical trial; the first posting was on October 1st 2016 and the last update occured November 18th 2022. If you're looking to participate in other trials involving multiple myeloma or Carfilzomib, there are currently 807 and 705 studies respectively recruiting patients."

Answered by AI

Are any North American locations participating in this investigation?

"There are seven medical sites accepting patients for this study, such as Memorial Sloan Kettering Monmouth in Middletown and Memorial Sloan Kettering Bergen in Montvale. Additionally, there are four other locations that can accommodate trial participants."

Answered by AI

Are there still vacancies available for inclusion in this experiment?

"According to clinicaltrials.gov, this particular trial, which was initially posted on October 1st 2016 and last updated on November 18th 2022 is not currently recruiting patients. Nevertheless, there are 1512 other trials in progress that may be a viable option for individuals seeking out medical treatments."

Answered by AI
~2 spots leftby Oct 2024