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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
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
Patients must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimens
Must not have
Peripheral neuropathy ≥ Grade 2 at screening
CNS involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Pivotal Trial
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.
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.
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 belowSelect...
I had a stem cell transplant for my condition and my disease hasn’t worsened in the first 100 days post-transplant.
Select...
I started my first cancer treatment less than a year ago and have tried up to 2 different treatments.
Select...
My liver tests are within normal limits.
Select...
I am fully active or can carry out light work.
Select...
My kidney function, measured by creatinine clearance, is sufficient.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have moderate to severe numbness, tingling, or pain in my hands or feet.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I have started or received treatment after a transplant.
Select...
I cannot tolerate lenalidomide, carfilzomib, or dexamethasone.
Select...
I have Waldenström's macroglobulinemia or IgM myeloma.
Select...
I have mild to no diarrhea without taking medication for it.
Select...
I haven't had a heart attack in the last 6 months and don't have severe heart issues.
Select...
My blood pressure or diabetes is not well-managed.
Select...
I have not taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.
Select...
I haven't had cancer except for certain types in the last 3 years.
Select...
I have had no more than two initial treatments, not counting dexamethasone alone.
Select...
I have not had radiotherapy in the last 14 days, or within 7 days if it was to a single area.
Select...
I have been diagnosed with plasma cell leukemia.
Select...
My condition worsened after my first treatment.
Select...
I have not had major surgery in the last 3 weeks.
Select...
I have had a blood clot in my veins or lungs.
Select...
I have POEMS syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival rates in participants receiving drug combination
Secondary study objectives
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 • 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%
Hypocalcaemia
16%
Neutrophil count increased
16%
Hypoalbuminaemia
16%
Blood lactate dehydrogenase increased
15%
Blood pressure increased
15%
Blood uric acid increased
15%
Lung infection
14%
Blood bilirubin increased
14%
Hyperglycaemia
14%
White blood cell count increased
14%
Blood glucose increased
14%
Constipation
12%
Neutrophil percentage increased
12%
Blood urea increased
11%
Alanine aminotransferase increased
11%
Hypercalcaemia
11%
Hyponatraemia
10%
Bronchitis
10%
Blood potassium decreased
10%
Oedema peripheral
10%
Neuropathy peripheral
10%
Productive cough
10%
Aspartate aminotransferase increased
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Hypoproteinaemia
8%
Influenza
8%
Blood albumin decreased
8%
Blood phosphorus increased
7%
Peripheral swelling
7%
Back pain
7%
Hypophosphataemia
7%
Mean cell volume increased
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Vomiting
7%
Abdominal distension
7%
Cataract
7%
Nasopharyngitis
6%
Hypoglycaemia
6%
Gamma-glutamyltransferase increased
6%
Thrombocytopenia
6%
Hyperkalaemia
6%
Hepatic function abnormal
6%
Respiratory tract infection
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%
Obstructive airways disorder
1%
Chronic kidney disease
1%
Interstitial lung disease
1%
Pleural effusion
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
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Lenalidomide
FDA approved
Dexamethasone
FDA approved
Carfilzomib
FDA approved
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,053 Previous Clinical Trials
758,894 Total Patients Enrolled
19 Trials studying Multiple Myeloma
2,290 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe numbness, tingling, or pain in my hands or feet.I have started or received treatment after a transplant.I cannot tolerate lenalidomide, carfilzomib, or dexamethasone.I have Waldenström's macroglobulinemia or IgM myeloma.Your heart's electrical activity (QT interval) is longer than normal on a screening heart test.I have mild to no diarrhea without taking medication for it.Your white blood cell count, red blood cell count, and platelet count are within certain healthy ranges.I haven't had a heart attack in the last 6 months and don't have severe heart issues.My blood pressure or diabetes is not well-managed.I have not taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.I haven't had cancer except for certain types in the last 3 years.I have been under cancer treatment for over a year.I will provide a bone marrow sample for the study.My cancer has spread to my brain or spinal cord.I agree to use protection during sex throughout the study and for 28 days after, even though I've had a vasectomy.I had a stem cell transplant for my condition and my disease hasn’t worsened in the first 100 days post-transplant.I started my first cancer treatment less than a year ago and have tried up to 2 different treatments.My liver tests are within normal limits.I have had no more than two initial treatments, not counting dexamethasone alone.I have not had radiotherapy in the last 14 days, or within 7 days if it was to a single area.I have been diagnosed with plasma cell leukemia.My condition worsened after my first treatment.I am fully active or can carry out light work.Your disease is getting worse according to specific guidelines.I have not had major surgery in the last 3 weeks.I have had a blood clot in my veins or lungs.I am 18 years old or older.I have POEMS syndrome.My kidney function, measured by creatinine clearance, is sufficient.I changed my treatment due to poor response or side effects but my cancer has not worsened.I do not have an active HIV, HBV (unless from vaccine), or HCV infection.
Research Study Groups:
This trial has the following groups:- Group 1: Lenalidomide (Control)
- Group 2: Experimental Combination Regimen
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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