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Proteasome Inhibitor
Quadruple Therapy for Multiple Myeloma (ASCENT Trial)
Phase 2
Waitlist Available
Led By Brian Durie, MD
Research Sponsored by International Myeloma Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
High risk smoldering myeloma, which is untreated, as defined by specific criteria
Able to take aspirin (325 mg) daily as prophylactic anticoagulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years post registration
Awards & highlights
ASCENT Trial Summary
This trial is testing a new treatment for people with a high-risk form of slow-growing blood cancer. The treatment consists of 3 phases, each lasting 6 or 12 cycles.
Who is the study for?
This trial is for adults aged 18-80 with high-risk smoldering multiple myeloma that hasn't been treated. Participants must be willing to use birth control, not have heart failure or HIV, and can't be pregnant or nursing. They should not have other serious health issues or recent major surgery and must agree to follow the study's procedures.Check my eligibility
What is being tested?
The study tests a combination of carfilzomib, lenalidomide, daratumumab, and dexamethasone in three phases over several cycles for treating high-risk smoldering multiple myeloma. Each phase has different durations but all aim to evaluate the effectiveness of this regimen.See study design
What are the potential side effects?
Possible side effects include fatigue, blood clots, nerve damage (neuropathy), low blood counts leading to increased infection risk or bleeding problems, allergic reactions to medication components, and potential heart complications.
ASCENT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My smoldering myeloma is high risk and untreated.
Select...
I can take daily aspirin for blood clot prevention.
Select...
I am between 18 and 80 years old.
ASCENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years post registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years post registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stringent complete response rate
Secondary outcome measures
Adverse events
MRD negativity after each treatment phase
MRD negativity at 1 year post treatment
+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
ASCENT Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm AExperimental Treatment4 Interventions
Non-high dose treatment in 3 phases Induction 6 cycles: carfilzomib, lenalidomide, daratumumab, dexamethasone Consolidation 6 cycles: carfilzomib, lenalidomide, daratumumab, dexamethasone Maintenance 12 cycles: lenalidomide, daratumumab
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
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
International Myeloma FoundationLead Sponsor
4 Previous Clinical Trials
347 Total Patients Enrolled
4 Trials studying Multiple Myeloma
347 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,601 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,653 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,431 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,009 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have hepatitis B or active hepatitis C infection.I have heart problems that are not currently under control.I have heart failure that affects my daily activities.I have had radiation therapy for bone lesions or plasmacytomas.I am not pregnant, nursing, or if capable of childbearing, I agree to use contraception.I have not had major surgery in the last 2 weeks.My smoldering myeloma is high risk and untreated.I haven't had or been treated for another cancer within the last 2 years.I can take daily aspirin for blood clot prevention.I have severe nerve pain or damage in my hands or feet.I have been diagnosed with a specific blood or bone marrow condition.You have other health conditions that would make it difficult for you to take part in the trial.I am willing to go back to the hospital where I enrolled for my treatment check-ups.You are expected to live for more than 6 months.I am between 18 and 80 years old.You are currently receiving other experimental treatments or chemotherapy.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
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.
When did Carfilzomib receive FDA approval in the United States?
"While there is some data indicating that Carfilzomib is safe, it received a score of 2 because there are no studies demonstrating its efficacy."
Answered by AI
What are some of the conditions that Carfilzomib has been effective in treating?
"Carfilzomib can be used to manage ophthalmia, sympathetic, at least two prior systemic chemotherapy regimens, and branch retinal vein occlusion."
Answered by AI
How many individuals are receiving treatment as part of this experiment?
"Unfortunately, this specific clinical trial is no longer looking for patients. The study was originally posted on May 25th, 2018 and had its last update on July 8th, 2022. However, there are presently 828 studies actively enrolling patients with smoldering multiple myeloma and 785 studies for Carfilzomib that have open recruitment statuses."
Answered by AI
What is the existing research on Carfilzomib's medical efficacy?
"Carfilzomib was first trialed in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. As of now, there have been 1398 completed trials with 785 ongoing studies. A large majority of these are located in Indianapolis, Indiana."
Answered by AI
Do we still have the opportunity to enroll more individuals in this clinical trial?
"Enrollment for this clinical trial has already closed. The original posting was on May 25th, 2018 with the most recent edit being on July 8th, 2022. There are currently 828 trials actively recruiting participants with smoldering multiple myeloma and 785 trials for Carfilzomib that have open enrollment."
Answered by AI
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