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Proteasome Inhibitor

Carfilzomib + Pomalidomide + Dexamethasone for Multiple Myeloma

Phase 2

Waitlist Available

Led By Ajay Nooka, MD, MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide through 90 days after the last dose of study drug

Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1

Must not have

Diagnosed with specific conditions including smoldering multiple myeloma (MM), monoclonal gammopathy of undetermined significance, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis or standard risk myeloma or secondary plasma cell leukemia

Known significant cardiac abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose until documented progression or death, assessed at 18 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 100 Other Conditions

Summary

This trial will study how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma.

Who is the study for?

This trial is for adults with high-risk multiple myeloma who've possibly had a stem cell transplant and responded to treatment. They must be able to follow the study plan, use effective birth control, and not have other serious health issues or recent major surgeries. People with certain heart conditions, infections like HIV or hepatitis B/C, previous cancers (except some skin/cervical), allergies to study drugs, or poor reaction to steroids can't join.

What is being tested?

The trial tests a combination of three drugs: Carfilzomib (blocks enzymes needed for cancer cells growth), Pomalidomide and Dexamethasone (both chemotherapy agents that kill or stop cancer cells from growing). It aims to see if this mix works better for those with aggressive multiple myeloma.

What are the potential side effects?

Possible side effects include fatigue, nausea, risk of infection due to low blood counts, allergic reactions to the medication components, potential heart complications related to Carfilzomib usage, nerve damage symptoms like numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am committed to using two forms of birth control before, during, and after taking pomalidomide.

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I am fully active or can carry out light work.

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I am a woman capable of becoming pregnant.

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I had a stem cell transplant within a year of my diagnosis and my condition has partially improved.

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 a specific blood or bone marrow condition.

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I have known serious heart problems.

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I have had a stroke or brain injury that still affects me.

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I had major surgery less than 4 weeks ago or am still dealing with its side effects.

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I am currently pregnant or breastfeeding.

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I do not have any serious illnesses like uncontrolled diabetes or active infections.

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I cannot take certain blood thinners due to allergies or side effects.

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I am currently undergoing or have previously had treatment for myeloma.

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I have a known brain or spinal cord condition.

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I am at high risk and did not reach partial remission after my stem cell transplant.

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I am allergic or react badly to the study drugs or similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose until documented progression or death, assessed at 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose until documented progression or death, assessed at 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose until documented progression or death, assessed at 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

≥ Complete response (CR) rates

Secondary study objectives

Best response on-study

Duration of response (DOR)

Minimal residual disease (MRD) detection

+3 more

Side effects data

From 2021 Phase 3 trial • 126 Patients • NCT03029234

62%

Anaemia

49%

Platelet count decreased

49%

Upper respiratory tract infection

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%

Diarrhoea

17%

Hyperuricaemia

16%

Neutrophil count increased

16%

Hypocalcaemia

16%

Blood lactate dehydrogenase increased

16%

Hypoalbuminaemia

15%

Blood pressure increased

15%

Blood uric acid increased

15%

Lung infection

14%

White blood cell count increased

14%

Hyperglycaemia

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%

Aspartate aminotransferase increased

10%

Productive cough

10%

Blood potassium decreased

10%

Neuropathy peripheral

10%

Oedema peripheral

10%

Bronchitis

10%

Lymphocyte percentage decreased

Leukocytosis

Influenza

Blood albumin decreased

Hypoproteinaemia

Blood phosphorus increased

Hypophosphataemia

Bilirubin conjugated increased

Vomiting

Back pain

Peripheral swelling

Mean cell volume increased

Prealbumin decreased

Abdominal distension

Cataract

Nasopharyngitis

Hepatic function abnormal

Gamma-glutamyltransferase increased

Hypoglycaemia

Respiratory tract infection

Thrombocytopenia

Hyperkalaemia

Nausea

Vision blurred

Plasma cell myeloma

Acute kidney injury

Bone pain

Localised infection

Cardiac amyloidosis

Hypotension

Chronic kidney disease

Obstructive airways disorder

Pleural effusion

Interstitial lung disease

Deep vein thrombosis

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 100 Other Conditions

This treatment demonstrated efficacy for 100 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Carfilzomib, pomalidomide, dexamethasoneExperimental Treatment3 Interventions

Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

Pomalidomide

FDA approved

Carfilzomib

FDA approved

0 / 15Eligibility criteria met