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Proteasome Inhibitor
Carfilzomib + Pomalidomide + Dexamethasone + Daratumumab for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Andrzej Jakubowiak
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 years or older
Men must agree to use latex condom during sexual contact with women of childbearing potential (even if post vasectomy)
Must not have
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Plasma cell leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Summary
This trial is investigating adding two drugs, carfilzomib and daratumumab, to the combination of pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma.
Who is the study for?
This trial is for adults over 18 with relapsed or refractory multiple myeloma who've had at least one prior treatment and are not planning a stem cell transplant soon. They must have measurable disease, be able to follow the study plan, use birth control, and have good liver function and blood counts. People can't join if they've had recent cancer treatments, heart issues, certain other cancers within 3 years, uncontrolled conditions like hypertension or diabetes, active infections requiring drugs, HIV/AIDS, significant neuropathy or allergies to related drugs.
What is being tested?
The study tests adding carfilzomib to pomalidomide and dexamethasone in patients with multiple myeloma that has come back or didn't respond to treatment. It also looks at the effects of including daratumumab in this combination therapy. The trial involves increasing doses of these drugs to find out how well they work together.
What are the potential side effects?
Possible side effects include reactions at the infusion site from daratumumab; increased risk of infections; blood clots; fatigue; nausea; diarrhea from pomalidomide; high blood pressure and shortness of breath from carfilzomib; plus weight gain and mood changes from dexamethasone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I agree to use a latex condom during sex if my partner can have children.
Select...
I am registered and can follow the POMALYST REMS program.
Select...
My multiple myeloma has returned and needs treatment.
Select...
I have tried at least one treatment for my multiple myeloma, including lenalidomide.
Select...
I am able to care for myself and perform daily activities.
Select...
My kidneys are functioning well enough to clear waste.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with POEMS syndrome.
Select...
I have been diagnosed with plasma cell leukemia.
Select...
I have Waldenström's macroglobulinemia or IgM myeloma.
Select...
I have not had major surgery in the last 3 weeks.
Select...
I had a stem cell transplant less than 12 weeks ago.
Select...
I haven't had any cancer treatment in the last 21 days, except for thyroid hormones or estrogen replacement.
Select...
I haven't had a heart attack in the last 6 months and don't have severe heart issues.
Select...
I haven't taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.
Select...
I am HIV positive.
Select...
My condition did not improve with proteasome inhibitors, except for bortezomib or carfilzomib.
Select...
I cannot undergo the required hydration treatment due to existing lung, heart, or kidney issues.
Select...
I need procedures to remove excess fluid from my chest or abdomen.
Select...
I have or might have amyloidosis in an organ.
Select...
I am not planning to have a stem cell transplant in the next 6 months.
Select...
I haven't been in a drug study within the last 3 weeks or 5 half-lives of the drug.
Select...
I have been treated with daratumumab before.
Select...
My blood pressure or diabetes is not well-managed.
Select...
I am not allergic or unable to take medications like aspirin, allopurinol, or certain blood thinners.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Partial response rate after 4 courses according to International Myeloma Working Group (IMWG) criteria
Secondary study objectives
Duration of response
Overall response rate
Overall survival
+2 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%
Diarrhoea
17%
Hyperuricaemia
16%
Hypocalcaemia
16%
Hypoalbuminaemia
16%
Neutrophil count increased
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%
Aspartate aminotransferase increased
10%
Productive cough
10%
Blood potassium decreased
10%
Neuropathy peripheral
10%
Oedema peripheral
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Hypoproteinaemia
8%
Influenza
8%
Blood albumin decreased
8%
Blood phosphorus increased
7%
Peripheral swelling
7%
Bilirubin conjugated increased
7%
Hypophosphataemia
7%
Prealbumin decreased
7%
Vomiting
7%
Back pain
7%
Mean cell volume increased
7%
Abdominal distension
7%
Cataract
7%
Nasopharyngitis
6%
Respiratory tract infection
6%
Hypoglycaemia
6%
Thrombocytopenia
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Hepatic function abnormal
6%
Nausea
6%
Vision blurred
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Localised infection
2%
Cardiac amyloidosis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Hypotension
1%
Pleural effusion
1%
Deep vein thrombosis
1%
Chronic kidney disease
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: PdC GroupExperimental Treatment3 Interventions
Patients receive carfilzomib, pomalidomide, and dexamethasone at indicated doses and schedule every 28 days. Patients may continue to receive treatment in the absence of disease progression or unacceptable toxicity.
Group II: PdC + Dara GroupExperimental Treatment4 Interventions
Patients receive carfilzomib, pomalidomide, dexamethasone, and daratumumab at indicated doses and schedule every 28 days. Patients may continue to receive treatment in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~2000
Pomalidomide
2011
Completed Phase 2
~1020
Carfilzomib
2017
Completed Phase 3
~1310
dexamethasone
1995
Completed Phase 3
~9520
Find a Location
Who is running the clinical trial?
Multiple Myeloma Research FoundationOTHER
10 Previous Clinical Trials
3,476 Total Patients Enrolled
10 Trials studying Multiple Myeloma
3,476 Patients Enrolled for Multiple Myeloma
University of ChicagoLead Sponsor
1,034 Previous Clinical Trials
753,593 Total Patients Enrolled
17 Trials studying Multiple Myeloma
2,318 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,899 Total Patients Enrolled
590 Trials studying Multiple Myeloma
189,256 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You have had an allergic reaction to mannitol, thalidomide, lenalidomide, or pomalidomide in the past.I have been diagnosed with POEMS syndrome.I have been diagnosed with plasma cell leukemia.I have Waldenström's macroglobulinemia or IgM myeloma.Your bilirubin levels should be within a certain range.Your alanine aminotransferase (ALT) levels should be less than 2.5 times the upper limit of normal.Your absolute neutrophil count is equal to or higher than 1.0 x 10^9 per liter.I agree to use a latex condom during sex if my partner can have children.I have not had major surgery in the last 3 weeks.I had a stem cell transplant less than 12 weeks ago.I am HIV positive.I am registered and can follow the POMALYST REMS program.My condition did not improve with proteasome inhibitors, except for bortezomib or carfilzomib.My multiple myeloma has returned and needs treatment.I have tried at least one treatment for my multiple myeloma, including lenalidomide.I am able to care for myself and perform daily activities.My liver is working well.I cannot undergo the required hydration treatment due to existing lung, heart, or kidney issues.My condition worsened on lenalidomide or within 2 months after stopping it.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I haven't had cancer in the last 3 years, except for certain skin, thyroid, cervix, breast, or low-grade prostate cancers.I haven't had any cancer treatment in the last 21 days, except for thyroid hormones or estrogen replacement.I haven't taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.I do not have severe or painful nerve damage.Your AST level is less than 2.5 times the upper limit of normal.I need procedures to remove excess fluid from my chest or abdomen.I have or might have amyloidosis in an organ.My kidneys are functioning well enough to clear waste.You have a specific condition that can be measured.You are expected to live for at least 3 more months.If the test for a certain protein in the blood might not be accurate, then a different blood test can be used instead.I haven't had widespread radiotherapy or immunotherapy in the last 4 weeks.I am not planning to have a stem cell transplant in the next 6 months.Your blood contains high levels of free light chains, and the ratio of these chains is abnormal.Your hemoglobin level is at least 8 grams per deciliter.Women who can have children must have a negative pregnancy test within a specific time before starting the study treatment and again right before taking the first dose of pomalidomide.You have a current infection of hepatitis A, B, or C.I haven't been in a drug study within the last 3 weeks or 5 half-lives of the drug.I have been treated with daratumumab before.You have high levels of M-protein in your urine.Your blood platelet count should be at least 75 billion per liter, and you should not have received a platelet transfusion in the past two weeks.My blood pressure or diabetes is not well-managed.You have high levels of M-protein in your blood.I am not allergic or unable to take medications like aspirin, allopurinol, or certain blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: PdC Group
- Group 2: PdC + Dara Group
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.
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