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Proteasome Inhibitor

Triple Drug Therapy for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Saad Usmani, MD
Research Sponsored by Saad Z. Usmani, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented history of relapsed and/or refractory multiple myeloma with > 2 lines of therapy, including a carfilzomib containing regimen with evidence of relapse or progression within the last 60 days of the carfilzomib containing regimen with a carfilzomib dose of at least 27 mg/m2
Measurable disease as defined by serum monoclonal protein level ≥0.5 g/dL for IgG, IgA, or IgM disease, urinary M-protein excretion of ≥200 mg over a 24-hour period, or involved free light chain level ≥10 mg/dL, along with an abnormal free light chain ratio
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 5 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will assess the safety and efficacy of combining the drugs ruxolitinib, carfilzomib, and dexamethasone to treat multiple myeloma.

Who is the study for?
Adults aged 18-75 with relapsed/refractory multiple myeloma, who've had at least two prior treatments including carfilzomib and shown progression within 60 days. Participants need good liver, heart, kidney function, not be pregnant or breastfeeding, have no severe psychiatric illnesses or other cancers, and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety of different doses of ruxolitinib combined with carfilzomib and dexamethasone (Phase I), followed by assessing how well this combination prevents disease progression over four months in patients with multiple myeloma (Phase II).See study design
What are the potential side effects?
Potential side effects include liver issues due to ruxolitinib; heart problems from carfilzomib; immune system suppression leading to infections; blood clots; fatigue; nausea from dexamethasone. Each drug can also cause unique side effects that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My multiple myeloma has returned or didn't respond to treatment, including one with carfilzomib.
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My blood tests show signs of disease with specific protein levels.
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My blood tests show enough white blood cells and platelets for my level of bone marrow cancer.
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My liver tests are within the required range.
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My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.
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My heart's pumping ability is at least 40%.
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I am between 18 and 75 years old.
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I am able to get out of my bed or chair and move around.
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I agree to use two effective birth control methods during and after the study.
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I have recovered from side effects of my previous treatment, except for hair loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 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
4-Month Progression Free Survival
Dose Limiting Toxicity (DLT)
Secondary outcome measures
Clinical Benefit Rate
Disease Control Rate
Duration of Response
+5 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 uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
Blood bilirubin increased
14%
White blood cell count 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%
Peripheral swelling
7%
Prealbumin decreased
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%
Lipoma
1%
Dysuria
1%
Myelopathy
1%
Hypotension
1%
Asthma
1%
Spinal compression fracture
1%
Chronic kidney disease
1%
Cardiac failure acute
1%
Pathological fracture
1%
Periodontitis
1%
Nerve compression
1%
Deep vein thrombosis
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

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: Phase IIExperimental Treatment3 Interventions
Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen
Group II: Phase IExperimental Treatment3 Interventions
Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Dexamethasone
2007
Completed Phase 4
~2590
Carfilzomib
2017
Completed Phase 3
~1410

Find a Location

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
Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,346 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,293 Patients Enrolled for Multiple Myeloma
Incyte CorporationIndustry Sponsor
357 Previous Clinical Trials
54,926 Total Patients Enrolled
7 Trials studying Multiple Myeloma
447 Patients Enrolled for Multiple Myeloma

Media Library

Multiple Myeloma Research Study Groups: Phase I, Phase II

Frequently Asked Questions

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

Are there still opportunities for enrolment in this clinical experiment?

"According to clinicaltrials.gov, this medical research endeavor is actively seeking participants. Initially posted on March 1st 2019, the most recent modification was made in September 10th 2022."

Answered by AI

What is the ultimate aim of this trial?

"The primary outcome, Dose Limiting Toxicity (DLT), will be monitored for a time period of 4 months. Amgen has also reported that secondary objectives including Objective Response Rate (ORR), Duration of Response and Overall Survival are to be assessed as part of this trial. Specifically, ORR is defined as the best overall response achieved in accordance with International Myeloma Working Group criteria while Duration of Reponse refers to the amount of time between first objective status assessment and documented disease progression or death. Lastly, Overall Survival denotes duration from treatment initiation until patient's mortality due to any cause."

Answered by AI

How many test subjects are currently taking part in this experiment?

"Affirmative. Per the information supplied on clinicaltrials.gov, this medical trial is actively recruiting participants. It was first released to the public on March 1st 2019 and has since been updated as recently as September 10th 2022. As of now, 48 individuals are needed across 2 distinct sites."

Answered by AI

Is enrollment for this research open to individuals of all ages, even those under 30?

"According to the conditions of enrollment, any prospective participant must be at least 18 years old and not exceed 75."

Answered by AI

Has Carfilzomib been researched in any other investigations?

"Currently, 653 clinical trials are actively studying the effects of Carfilzomib with 157 in their third phase. While Joliet, Illinois is home to most of these studies, other cities across 21841 locations are also taking part."

Answered by AI

What maladies is Carfilzomib typically deployed to address?

"Carfilzomib is an efficacious option to combat ophthalmia, sympathetic and other communicable diseases. Additionally, it has been known to help those with branch retinal vein occlusion or macular edema manage their conditions."

Answered by AI

Who is eligible to join this clinical research project?

"This clinical trial is searching for 48 viable candidates aged 18 to 75 with a documented history of relapsed and/or refractory multiple myeloma, serum monoclonal protein level ≥0.5 g/dL, urinary M-protein excretion of ≥200 mg over a 24-hour period, involved free light chain level ≥10 mg/dL plus an abnormal free light chain ratio, ANC ≥1000 cells/mm3 within 1 week prior to the start of treatment, platelet count depending on bone marrow plasmacytosis levels (≥75 ,000 or 50 ,000), total bilirubin ≤"

Answered by AI
~2 spots leftby Feb 2025