Study Summary
This trial will assess the safety and efficacy of combining the drugs ruxolitinib, carfilzomib, and dexamethasone to treat multiple myeloma.
Eligible Conditions
- Multiple Myeloma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: approx. 5 years
28 days
Dose Limiting Toxicity (DLT)
4 months
4-Month Progression Free Survival
Day 30
Clinical Benefit Rate
Objective Response Rate (ORR)
Time to Best Response
approx. 5 years
Duration of Response
Overall Survival
Progression-free survival (PFS)
Time to Progression
Week 8
Disease Control Rate
Trial Safety
Safety Progress
Side Effects for
Carfilzomib With Dexamethasone
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%Hyperuricaemia
17%Diarrhoea
16%Blood lactate dehydrogenase increased
16%Hypoalbuminaemia
16%Hypocalcaemia
16%Neutrophil count increased
15%Blood uric acid increased
15%Blood pressure increased
15%Lung infection
14%White blood cell count increased
14%Blood bilirubin increased
14%Hyperglycaemia
14%Blood glucose increased
14%Constipation
12%Blood urea increased
12%Neutrophil percentage increased
11%Hyponatraemia
11%Alanine aminotransferase increased
11%Hypercalcaemia
10%Blood potassium decreased
10%Productive cough
10%Lymphocyte percentage decreased
10%Oedema peripheral
10%Bronchitis
10%Neuropathy peripheral
10%Aspartate aminotransferase increased
9%Leukocytosis
8%Hypoproteinaemia
8%Blood phosphorus increased
8%Blood albumin decreased
8%Influenza
7%Mean cell volume increased
7%Cataract
7%Hypophosphataemia
7%Back pain
7%Bilirubin conjugated increased
7%Prealbumin decreased
7%Vomiting
7%Peripheral swelling
7%Nasopharyngitis
7%Abdominal distension
6%Nausea
6%Hypoglycaemia
6%Thrombocytopenia
6%Respiratory tract infection
6%Vision blurred
6%Hyperkalaemia
6%Gamma-glutamyltransferase increased
6%Hepatic function abnormal
3%Acute kidney injury
3%Plasma cell myeloma
2%Cardiac amyloidosis
2%Bone pain
2%Localised infection
1%Spinal compression fracture
1%Pleural effusion
1%Otitis media
1%Cerebral ischaemia
1%Periodontitis
1%Dysuria
1%Soft tissue infection
1%Interstitial lung disease
1%Pancreatitis acute
1%Infusion site extravasation
1%Obstructive airways disorder
1%Lipoma
1%Organising pneumonia
1%Pathological fracture
1%Pain
1%Device related infection
1%Disease progression
1%Asthma
1%Nerve compression
1%Myolipoma
1%Escherichia sepsis
1%Deep vein thrombosis
1%Myelopathy
1%Cardiac failure acute
1%Bronchiolitis
1%Supraventricular tachycardia
1%Chronic kidney disease
1%Neuralgia
1%Hypotension
Trial Design
1 Treatment Group
Phase I
1 of 1
Experimental Treatment
12 Total Participants · 1 Treatment Group
Primary Treatment: Carfilzomib · No Placebo Group · Phase 1 & 2
Phase IExperimental Group · 3 Interventions: Ruxolitinib, Dexamethasone, Carfilzomib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved
Dexamethasone
FDA approved
Carfilzomib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approx. 5 years
Who is running the clinical trial?
Saad Z. Usmani, MDLead Sponsor
4 Previous Clinical Trials
54 Total Patients Enrolled
4 Trials studying Multiple Myeloma
54 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,296 Previous Clinical Trials
1,328,806 Total Patients Enrolled
95 Trials studying Multiple Myeloma
20,617 Patients Enrolled for Multiple Myeloma
Shebli AtrashLead Sponsor
2 Previous Clinical Trials
70 Total Patients Enrolled
2 Trials studying Multiple Myeloma
70 Patients Enrolled for Multiple Myeloma
Incyte CorporationIndustry Sponsor
313 Previous Clinical Trials
46,434 Total Patients Enrolled
5 Trials studying Multiple Myeloma
443 Patients Enrolled for Multiple Myeloma
Multiple Myeloma Research ConsortiumNETWORK
18 Previous Clinical Trials
1,134 Total Patients Enrolled
17 Trials studying Multiple Myeloma
1,081 Patients Enrolled for Multiple Myeloma
Wake Forest University Health SciencesLead Sponsor
1,121 Previous Clinical Trials
1,127,002 Total Patients Enrolled
18 Trials studying Multiple Myeloma
3,682 Patients Enrolled for Multiple Myeloma
Saad Usmani, MDPrincipal InvestigatorAtrium Health
6 Previous Clinical Trials
375 Total Patients Enrolled
6 Trials studying Multiple Myeloma
375 Patients Enrolled for Multiple Myeloma
Shebli Atrash, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
1 Trials studying Multiple Myeloma
Eligibility Criteria
Age 18 - 75 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The patient has a serum monoclonal protein level of 0.
You have urinary M-protein excretion of ≥200 mg over a 24-hour period.
You have a serum free light chain level of 10 mg/dL or higher, along with an abnormal free light chain ratio.
ANC >1000 cells/mm3 within 1 week of the initiation of treatment.
You have a platelet count of ≥75,000 cells/mm3 or a platelet count of ≥50,000 cells/mm3 for subjects who have bone marrow plasmacytosis of <50% or ≥50% respectively.
You have adequate cardiac function.
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Conditions
Cancer Related
Treatments