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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from partial response to disease progression, up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 agree to use birth control during the study.
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I have high-risk Smoldering Multiple Myeloma.
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My organ and bone marrow functions are normal.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neoplasm, Residual
Secondary outcome measures
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%
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%
Blood creatinine increased
19%
Insomnia
18%
Pyrexia
17%
Diarrhoea
17%
Hyperuricaemia
16%
Blood lactate dehydrogenase increased
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Hypoalbuminaemia
15%
Blood pressure increased
15%
Blood uric acid increased
15%
Lung infection
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
14%
Hyperglycaemia
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Hyponatraemia
11%
Alanine aminotransferase increased
11%
Hypercalcaemia
10%
Blood potassium decreased
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Bronchitis
10%
Aspartate aminotransferase increased
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood albumin decreased
8%
Blood phosphorus increased
8%
Hypoproteinaemia
8%
Influenza
7%
Prealbumin decreased
7%
Peripheral swelling
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Nasopharyngitis
7%
Bilirubin conjugated increased
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Thrombocytopenia
6%
Vision blurred
6%
Nausea
6%
Hepatic function abnormal
6%
Respiratory tract infection
6%
Hyperkalaemia
6%
Hypoglycaemia
3%
Acute kidney injury
3%
Plasma cell myeloma
2%
Bone pain
2%
Localised infection
2%
Cardiac amyloidosis
1%
Pathological fracture
1%
Dysuria
1%
Hypotension
1%
Cardiac failure acute
1%
Spinal compression fracture
1%
Lipoma
1%
Periodontitis
1%
Asthma
1%
Deep vein thrombosis
1%
Myelopathy
1%
Chronic kidney disease
1%
Nerve compression
1%
Otitis media
1%
Soft tissue infection
1%
Cerebral ischaemia
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Pleural effusion
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
1%
Pain
1%
Bronchiolitis
1%
Device related infection
1%
Pancreatitis acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone

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
~1440
Revlimid
2005
Completed Phase 3
~730
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,591 Total Patients Enrolled
572 Trials studying Multiple Myeloma
187,930 Patients Enrolled for Multiple Myeloma
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,117 Total Patients Enrolled
5 Trials studying Multiple Myeloma
959 Patients Enrolled for Multiple Myeloma
Elizabeth Hill, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01572480 — Phase 2
Multiple Myeloma Research Study Groups: Group A - (closed) - Carfilzomib with Revlimid and Dexamethasone, Group B - Carfilzomib with Revlimid and Dexamethasone
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT01572480 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01572480 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Carfilzomib been granted regulatory approval by the Food and Drug Administration?

"Carfilzomib has not yet been verified to be efficacious, but there is some evidence of its safety and so it was assigned a rating of 2."

Answered by AI

How many participants are enrolled in this medical research experiment?

"Alas, no longer is this clinical trial recruiting participants. Initially posted on May 29th 2012 and last updated on August 17th 2022, the study has since ceased its search for volunteers. However, there are 808 trials searching for individuals with multiple myeloma and 704 studies looking to recruit people taking Carfilzomib."

Answered by AI

Have any other experiments been carried out regarding the use of Carfilzomib?

"Presently, 704 medical trials are researching the effects of Carfilzomib. Of those studies, 167 have entered Phase 3 testing. While Mishawaka, Indiana is a hub for research on this medication, there are over 25 thousand other sites running tests all across the world."

Answered by AI

What clinical indications is Carfilzomib most regularly employed to address?

"Carfilzomib is typically used to manage ophthalmia and sympathetic conditions, but can also be a viable intervention for other diseases such as branch retinal vein occlusion and macular edema in patients that have already received two systemic chemotherapies."

Answered by AI

Is this clinical investigation currently accepting participants?

"Recruitment for this medical trial has concluded; its initial posting occured on May 29th 2012, with the latest edit taking place on August 17th 2022. For those exploring other studies, there are 808 active clinical trials looking for individuals with multiple myeloma and 704 featuring Carfilzomib as their intervention of choice."

Answered by AI

To what end is this clinical trial striving?

"This 8-month long clinical trial aims to measure Response Rate as its primary outcome, with other secondary objectives being the assessment of adverse events via CTCAE v4.0, MRDnegative Complete Responses persisting for a minimum of 1 year and Clinical Progression Free Survival from enrolment until development of overt multiple myeloma or death."

Answered by AI
Recent research and studies
~4 spots leftby Mar 2025