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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 belowSelect...
I am 18 years old or older.
Select...
My condition is confirmed as Smoldering Multiple Myeloma by a recognized lab.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have high-risk Smoldering Multiple Myeloma.
Select...
My organ and bone marrow functions are normal.
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
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 moreSide effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
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%
Hypoalbuminaemia
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Blood lactate dehydrogenase increased
15%
Blood uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
Hyperglycaemia
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Alanine aminotransferase increased
11%
Hyponatraemia
11%
Hypercalcaemia
10%
Aspartate aminotransferase increased
10%
Blood potassium decreased
10%
Bronchitis
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood phosphorus increased
8%
Influenza
8%
Blood albumin decreased
8%
Hypoproteinaemia
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Peripheral swelling
7%
Nasopharyngitis
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Thrombocytopenia
6%
Vision blurred
6%
Respiratory tract infection
6%
Hepatic function abnormal
6%
Nausea
6%
Hypoglycaemia
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Cardiac amyloidosis
2%
Localised infection
1%
Pain
1%
Periodontitis
1%
Myelopathy
1%
Device related infection
1%
Dysuria
1%
Pleural effusion
1%
Otitis media
1%
Pancreatitis acute
1%
Spinal compression fracture
1%
Lipoma
1%
Cerebral ischaemia
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Soft tissue infection
1%
Nerve compression
1%
Chronic kidney disease
1%
Hypotension
1%
Asthma
1%
Bronchiolitis
1%
Pathological fracture
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
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
~1400
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
13,717 Previous Clinical Trials
40,953,309 Total Patients Enrolled
588 Trials studying Multiple Myeloma
189,370 Patients Enrolled for Multiple Myeloma
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,109 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a GI condition that affects my body's ability to absorb medications.I do not have severe nerve pain or damage.You are currently taking any other experimental medications.You had another type of cancer in the past, but it has been 2 years since you had treatment and you are not currently having any symptoms.I have not had major surgery in the last month.My condition is confirmed as Smoldering Multiple Myeloma by a recognized lab.My blood pressure or diabetes is not well-managed.I have serious heart issues, including recent heart attacks or unstable heart conditions.I do not have an active hepatitis B or C infection.I can take care of myself but might not be able to do heavy physical work.I agree to use birth control during the study.I am allergic to medications similar to carfilzomib or lenalidomide.I have high-risk Smoldering Multiple Myeloma.I have not had any treatments for SMM in the last 4 weeks.You have a measurable disease according to specific guidelines within the past 4 weeks.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.I am allergic or react badly to certain medications.I have been diagnosed with multiple myeloma.My organ and bone marrow functions are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Group A - (closed) - Carfilzomib with Revlimid and Dexamethasone
- Group 2: Group B - Carfilzomib with Revlimid and Dexamethasone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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