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Proteasome Inhibitor

Carfilzomib + Lenalidomide + Dexamethasone for Multiple Myeloma

Phase 3
Waitlist Available
Led By Andrzej Jakubowiak, MD, PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bone marrow specimen will be required at study entry; available DNA sample will be used for calibration step for MRD evaluation by gene sequencing
Patients who completed single autologous stem cell transplant after completion of at most 2 induction regimens (excluding dexamethasone alone) and are in at least stable disease in the first 100 days after stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing carfilzomib, lenalidomide, and dexamethasone versus lenalidomide alone as a maintenance treatment for multiple myeloma after stem-cell transplant.

Who is the study for?
Adults over 18 with multiple myeloma who've had a stem-cell transplant can join this trial. They should be in good health, have stable disease post-transplant, and agree to birth control measures if applicable. Exclusions include recent radiation or surgery, certain heart conditions, uncontrolled blood pressure or diabetes, active infections, and known HIV/HBV/HCV infection.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining Carfilzomib with Lenalidomide and Dexamethasone against using only Lenalidomide after a stem-cell transplant in multiple myeloma patients. It's randomized: some get all drugs; others just one.See study design
What are the potential side effects?
Possible side effects include liver issues (yellowing skin/eyes), digestive problems (nausea/vomiting), low blood counts leading to increased infection risk or bleeding tendencies, muscle weakness or pain, nerve damage causing numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will provide a bone marrow sample for the study.
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I had a stem cell transplant for my condition and my disease hasn’t worsened in the first 100 days post-transplant.
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I started my first cancer treatment less than a year ago and have tried up to 2 different treatments.
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My liver tests are within normal limits.
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I agree to use protection during sex throughout the study and for 28 days after, even though I've had a vasectomy.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My kidney function, measured by creatinine clearance, is sufficient.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival rates in participants receiving drug combination
Secondary outcome measures
Rate of minimal residual negative disease (MRD) in participants receiving drug combination
Response rate in participants receiving drug combination
Treatment-related side effects

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

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Combination RegimenExperimental Treatment3 Interventions
Experimental arm using a combination of Carfilzomib, Lenalidomide and Dexamethasone
Group II: Lenalidomide (Control)Active Control1 Intervention
Treatment with lenalidomide only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Carfilzomib
FDA approved
Lenalidomide
FDA approved

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
995 Previous Clinical Trials
816,488 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,789 Patients Enrolled for Multiple Myeloma
Andrzej Jakubowiak, MD, PhDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Multiple Myeloma
75 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02659293 — Phase 3
Multiple Myeloma Research Study Groups: Lenalidomide (Control), Experimental Combination Regimen
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT02659293 — Phase 3
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02659293 — Phase 3

Frequently Asked Questions

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

Are there other examples of Carfilzomib being used in research?

"Carfilzomib was first studied in 2002 and there have been 1376 completed trials as of now. There are 736 active trials being conducted globally, with a large number centred around Detroit, Michigan."

Answered by AI

What are the Carfilzomib's common usages?

"Carfilzomib is a medication typically used to treat ophthalmia, sympathetic. It can also be effective in managing branch retinal vein occlusion and macular edema among patients that have undergone at least two different rounds of systemic chemotherapy."

Answered by AI

Are individuals currently being sought for this experiment?

"The study in question is not enrolling patients at the moment, according to the information on clinicaltrials.gov. This research was originally posted on April 26th, 2016 but has since been edited on June 29th, 2021. Although this specific trial isn't looking for candidates currently, there are 1562 other trials that are actively recruiting right now."

Answered by AI

When was Carfilzomib cleared by the FDA?

"There is some efficacy data and multiple safety trials for Carfilzomib, giving it a score of 3 on our Power team's scale."

Answered by AI

What is the total amount of people that can partake in this research?

"This study is now closed to new patients. The clinical trial was posted on 4/26/2016 and edited for the last time on 6/29/2021. There are, however, 826 other trials for multiple myeloma and 736 studies involving Carfilzomib that are still recruiting participants."

Answered by AI
~12 spots leftby Nov 2024