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Proteasome Inhibitor
Carfilzomib + Pomalidomide + Dexamethasone + Daratumumab for Multiple Myeloma
Phase 1 & 2
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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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.
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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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of carfilzomib when administered in combination with pomalidomide and dexamethasone
Partial response rate after 4 courses according to International Myeloma Working Group (IMWG) criteria
Response rates of carfilzomib, pomalidomide, dexamethasone, and daratumumab dosing according to International Myeloma Working Group (IMWG) criteria
Secondary outcome measures
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%
Hyperuricaemia
17%
Diarrhoea
16%
Hypoalbuminaemia
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Blood lactate dehydrogenase increased
15%
Blood uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
Hyperglycaemia
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Alanine aminotransferase increased
11%
Hyponatraemia
11%
Hypercalcaemia
10%
Aspartate aminotransferase increased
10%
Blood potassium decreased
10%
Bronchitis
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood phosphorus increased
8%
Influenza
8%
Blood albumin decreased
8%
Hypoproteinaemia
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Peripheral swelling
7%
Nasopharyngitis
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Thrombocytopenia
6%
Vision blurred
6%
Respiratory tract infection
6%
Hepatic function abnormal
6%
Nausea
6%
Hypoglycaemia
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Cardiac amyloidosis
2%
Localised infection
1%
Pain
1%
Periodontitis
1%
Myelopathy
1%
Device related infection
1%
Dysuria
1%
Pleural effusion
1%
Otitis media
1%
Pancreatitis acute
1%
Spinal compression fracture
1%
Lipoma
1%
Cerebral ischaemia
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Soft tissue infection
1%
Nerve compression
1%
Chronic kidney disease
1%
Hypotension
1%
Asthma
1%
Bronchiolitis
1%
Pathological fracture
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
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
~1860
Pomalidomide
2011
Completed Phase 2
~1020
Carfilzomib
2017
Completed Phase 3
~1440
dexamethasone
1995
Completed Phase 3
~9860
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
1,004 Previous Clinical Trials
819,676 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,868 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,753 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,030 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have there been further investigations into the use of Carfilzomib?
"Carfilzomib was first studied by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba in 2002. Since then, 1178 clinical trials have ended and 629 are ongoing - with a large concentration of research located in Nashville, Tennessee."
Answered by AI
What is the cap on patient participation for this trial?
"Affirmative. According to the information found on clinicaltrials.gov, this research trial is actively enrolling participants as of 1/7/2022 since it was first posted on 8/13/2012. The study requires around 101 individuals from 2 different locations for full participation."
Answered by AI
Are there any opportunities for enrolment into this experiment?
"As stated on clinicaltrials.gov, this medical experiment is presently accruing participants. It was initially posted in August 2012 and recently updated in January 2022."
Answered by AI
What medical conditions are typically ameliorated with Carfilzomib?
"Carfilzomib is frequently prescribed for ophthalmia, sympathetic and has also been found to be effective against branch retinal vein occlusion, macular edema, as well as communicable diseases."
Answered by AI
What is the purpose of this investigation?
"The principal objective of this 4-month long study, as determined by the International Myeloma Working Group (IMWG) criteria, is to determine partial response rate. Secondary outcomes include overall response rate with 95% binomial confidence intervals, duration of response and progression-free survival which will be calculated using Kaplan and Meier's product-limit method."
Answered by AI
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