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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

No Placebo-Only Group

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 below

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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.

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I am registered and can follow the POMALYST REMS program.

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My multiple myeloma has returned and needs treatment.

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I have tried at least one treatment for my multiple myeloma, including lenalidomide.

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I am able to care for myself and perform daily activities.

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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:

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I have been diagnosed with POEMS syndrome.

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I have been diagnosed with plasma cell leukemia.

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I have Waldenström's macroglobulinemia or IgM myeloma.

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I have not had major surgery in the last 3 weeks.

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I had a stem cell transplant less than 12 weeks ago.

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I haven't had any cancer treatment in the last 21 days, except for thyroid hormones or estrogen replacement.

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I haven't had a heart attack in the last 6 months and don't have severe heart issues.

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I haven't taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.

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I am HIV positive.

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My condition did not improve with proteasome inhibitors, except for bortezomib or carfilzomib.

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I cannot undergo the required hydration treatment due to existing lung, heart, or kidney issues.

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I need procedures to remove excess fluid from my chest or abdomen.

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I have or might have amyloidosis in an organ.

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I am not planning to have a stem cell transplant in the next 6 months.

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I haven't been in a drug study within the last 3 weeks or 5 half-lives of the drug.

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I have been treated with daratumumab before.

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My blood pressure or diabetes is not well-managed.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 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%

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%

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%

Blood potassium decreased

10%

Oedema peripheral

10%

Neuropathy peripheral

10%

Productive cough

10%

Aspartate aminotransferase increased

10%

Lymphocyte percentage decreased

Leukocytosis

Hypoproteinaemia

Influenza

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

Hypoglycaemia

Gamma-glutamyltransferase increased

Thrombocytopenia

Hyperkalaemia

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

Myelopathy

Chronic kidney disease

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

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