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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

No Placebo-Only Group

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.

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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.

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I am HIV positive.

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

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%

Insomnia

19%

Blood creatinine increased

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%

Hyperglycaemia

14%

White blood cell count increased

14%

Blood glucose increased

14%

Blood bilirubin increased

14%

Constipation

12%

Neutrophil percentage increased

12%

Blood urea increased

11%

Alanine aminotransferase increased

11%

Hypercalcaemia

11%

Hyponatraemia

10%

Neuropathy peripheral

10%

Bronchitis

10%

Blood potassium decreased

10%

Oedema peripheral

10%

Productive cough

10%

Aspartate aminotransferase increased

10%

Lymphocyte percentage decreased

Leukocytosis

Influenza

Hypoproteinaemia

Blood albumin decreased

Blood phosphorus increased

Peripheral swelling

Back pain

Hypophosphataemia

Mean cell volume increased

Prealbumin decreased

Bilirubin conjugated increased

Vomiting

Abdominal distension

Cataract

Nasopharyngitis

Gamma-glutamyltransferase increased

Thrombocytopenia

Hyperkalaemia

Hypoglycaemia

Hepatic function abnormal

Respiratory tract infection

Nausea

Vision blurred

Plasma cell myeloma

Acute kidney injury

Bone pain

Localised infection

Cardiac amyloidosis

Hypotension

Obstructive airways disorder

Interstitial lung disease

Pleural effusion

Deep vein thrombosis

Chronic kidney disease

Myelopathy

Organising pneumonia

Myolipoma

Neuralgia

Asthma

Lipoma

Cerebral ischaemia

Nerve compression

Disease progression

Infusion site extravasation

Escherichia sepsis

Otitis media

Periodontitis

Pathological fracture

Pain

Device related infection

Dysuria

Soft tissue infection

Spinal compression fracture

Cardiac failure acute

Supraventricular tachycardia

Bronchiolitis

Pancreatitis acute

100%

80%

60%

40%

20%

Study treatment Arm

Carfilzomib With Dexamethasone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2650

Carfilzomib

2017

Completed Phase 3

~1430