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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
Must not have
Evidence of current uncontrolled cardiovascular conditions
New York Heart Association (NYHA) II, III, IV heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years post registration
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My smoldering myeloma is high risk and untreated.
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I can take daily aspirin for blood clot prevention.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have heart problems that are not currently under control.
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I have heart failure that affects my daily activities.
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I have had radiation therapy for bone lesions or plasmacytomas.
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I haven't had or been treated for another cancer within the last 2 years.
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I am not pregnant, nursing, or if capable of childbearing, I agree to use contraception.
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I have not had major surgery in the last 2 weeks.
Select...
I have severe nerve pain or damage in my hands or feet.
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I have been diagnosed with a specific blood or bone marrow condition.
Select...
I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years post registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years post registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Stringent complete response rate
Secondary study objectives
Adverse events
MRD negativity after each treatment phase
MRD negativity at 1 year post treatment
+2 more

Side effects data

From 2021 Phase 3 trial • 126 Patients • NCT03029234
62%
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

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
~2640
Carfilzomib
2017
Completed Phase 3
~1310
Lenalidomide
2005
Completed Phase 3
~1340
Daratumumab
2014
Completed Phase 3
~2000

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
1,420 Previous Clinical Trials
1,382,863 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,653 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
161 Previous Clinical Trials
579,854 Total Patients Enrolled
23 Trials studying Multiple Myeloma
1,953 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03289299 — Phase 2
Multiple Myeloma Research Study Groups: Arm A
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT03289299 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03289299 — Phase 2
~12 spots leftby Sep 2025
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