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Proteasome Inhibitor

Carfilzomib + Lenalidomide + Dexamethasone for Multiple Myeloma

Phase 2

Waitlist Available

Led By Mark J Roschewski, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Age greater than or equal to 18 years

Patients must have histologically or cytologically confirmed Smoldering Multiple Myeloma confirmed by the Laboratory of Pathology, national Cancer Institute (NCI) or the Department of Laboratory Medicine, Clinical Center (CC) based on the International Myeloma Working Group Criteria

Must not have

Has refractory gastrointestinal (GI) disease with refractory nausea/vomiting, inflammatory bowel disease, or bowel resection that would prevent absorption

Major surgery within 1 month prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from partial response to disease progression, up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of three drugs as a possible treatment for smoldering multiple myeloma.

Who is the study for?

Adults with Smoldering Multiple Myeloma (SMM) likely to progress to multiple myeloma can join. They must understand and sign consent, agree to use contraception, have no other cancer treatments in the last 4 weeks, and meet health criteria including normal organ function and 'high-risk' SMM status.

What is being tested?

The trial tests a combination of Carfilzomib, Lenalidomide (Revlimid), and Dexamethasone for treating SMM. Participants will undergo eight cycles of treatment with these drugs followed by up to twelve additional cycles with just Lenalidomide if their disease doesn't progress.

What are the potential side effects?

Potential side effects include reactions related to immune system suppression such as increased infection risk, blood disorders, liver issues from Lenalidomide; steroid-related effects like mood swings or blood sugar changes from Dexamethasone; and heart or lung complications from Carfilzomib.

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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My condition is confirmed as Smoldering Multiple Myeloma by a recognized lab.

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I can take care of myself but might not be able to do heavy physical work.

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I have high-risk Smoldering Multiple Myeloma.

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My organ and bone marrow functions are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a GI condition that affects my body's ability to absorb medications.

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I have not had major surgery in the last month.

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My blood pressure or diabetes is not well-managed.

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I have serious heart issues, including recent heart attacks or unstable heart conditions.

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I do not have an active hepatitis B or C infection.

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I am allergic to medications similar to carfilzomib or lenalidomide.

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I am allergic or react badly to certain medications.

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I have been diagnosed with multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from partial response to disease progression, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from partial response to disease progression, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from partial response to disease progression, up to 5 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

Neoplasm, Residual

Secondary study objectives

Biochemical Progression Free Survival

Clinical Progression Free Survival

Duration of Response

+3 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: Group B - Carfilzomib with Revlimid and DexamethasoneExperimental Treatment3 Interventions

Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle)

Group II: Group A - (closed) - Carfilzomib with Revlimid and DexamethasoneExperimental Treatment3 Interventions

Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carfilzomib

2017

Completed Phase 3

~1430

Revlimid

2005

Completed Phase 3

~730