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Proteasome Inhibitor

Carfilzomib-based Chemotherapy for Multiple Myeloma (CarMob Trial)

Phase 1
Recruiting
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a confirmed diagnosis of multiple myeloma as specified by the International Myeloma Working Group criteria and must have measurable disease as defined by at least one of the following criteria: Serum monoclonal protein ≥ 0.5 g/dL, ≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis, Serum immunoglobulin free light chain: involved FLC ≥ 10 mg/dL (≥ 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Subjects must have completed any 'induction therapy' and have achieved less than a complete response (CR).
Must not have
Subject has received radiation therapy within 3 weeks of enrollment Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trial is testing a new cancer drug, Carfilzomib, given with other drugs, to see what dose is safe for people.

Who is the study for?
This trial is for adults over 18 with multiple myeloma who have had some treatment but not a complete response. They should expect to live more than 12 weeks, be in fairly good health with normal liver function and heart performance, and have an acceptable blood count. Women must test negative for pregnancy and agree to use contraception, as must men.
What is being tested?
The study tests different doses of Carfilzomib (20-70mg/m2) combined with Cyclophosphamide, Dexamethasone, and G-CSF in escalating groups using a '3+3 design' to find the best dose for stem cell transplant preparation in multiple myeloma patients.
What are the potential side effects?
Carfilzomib may cause fatigue, nausea, shortness of breath, fever, and risk of infection. It can also affect blood pressure and heart rhythm. Side effects from Cyclophosphamide include hair loss, mouth sores while Dexamethasone can cause weight gain and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have multiple myeloma with measurable indicators.
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I finished my initial cancer treatment but didn't achieve total remission.
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I am 18 years old or older.
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I can do all or most of my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had radiation therapy in the last 3 weeks.
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I do not have any uncontrolled illnesses like high blood pressure, diabetes, infections, or liver disease.
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I have undergone stem cell transplant or preparation for it.
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I have moderate to severe nerve damage in my hands or feet.
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I do not have any active infections or health issues that would make this treatment too risky for me.
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My high blood pressure is not under control.
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I have high blood pressure in the lungs.
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I do not have severe heart disease or recent heart attacks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

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%
Diarrhoea
17%
Hyperuricaemia
16%
Hypocalcaemia
16%
Hypoalbuminaemia
16%
Neutrophil count increased
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%
Aspartate aminotransferase increased
10%
Productive cough
10%
Blood potassium decreased
10%
Neuropathy peripheral
10%
Oedema peripheral
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Hypoproteinaemia
8%
Influenza
8%
Blood albumin decreased
8%
Blood phosphorus increased
7%
Peripheral swelling
7%
Bilirubin conjugated increased
7%
Hypophosphataemia
7%
Prealbumin decreased
7%
Vomiting
7%
Back pain
7%
Mean cell volume increased
7%
Abdominal distension
7%
Cataract
7%
Nasopharyngitis
6%
Respiratory tract infection
6%
Hypoglycaemia
6%
Thrombocytopenia
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Hepatic function abnormal
6%
Nausea
6%
Vision blurred
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Localised infection
2%
Cardiac amyloidosis
1%
Interstitial lung disease
1%
Pleural effusion
1%
Obstructive airways disorder
1%
Hypotension
1%
Deep vein thrombosis
1%
Chronic kidney disease
1%
Myelopathy
1%
Organising pneumonia
1%
Myolipoma
1%
Neuralgia
1%
Asthma
1%
Lipoma
1%
Cerebral ischaemia
1%
Nerve compression
1%
Disease progression
1%
Infusion site extravasation
1%
Escherichia sepsis
1%
Otitis media
1%
Periodontitis
1%
Pathological fracture
1%
Pain
1%
Device related infection
1%
Dysuria
1%
Soft tissue infection
1%
Spinal compression fracture
1%
Cardiac failure acute
1%
Supraventricular tachycardia
1%
Bronchiolitis
1%
Pancreatitis acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone

Trial Design

6Treatment groups
Experimental Treatment
Group I: Carfilzomib Mobilization - Dose Level 5Experimental Treatment4 Interventions
Carfilzomib at 70mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group II: Carfilzomib Mobilization - Dose Level 4Experimental Treatment4 Interventions
Carfilzomib at 56mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group III: Carfilzomib Mobilization - Dose Level 3Experimental Treatment4 Interventions
Carfilzomib at 45mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group IV: Carfilzomib Mobilization - Dose Level 2Experimental Treatment4 Interventions
Carfilzomib at 36mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group V: Carfilzomib Mobilization - Dose Level 1Experimental Treatment4 Interventions
Carfilzomib at 27mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group VI: Carfilzomib Mobilization - Dose Level 0Experimental Treatment4 Interventions
Carfilzomib at 20mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF. For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1310
Cyclophosphamide
2010
Completed Phase 4
~2320
Dexamethasone
2007
Completed Phase 4
~2640
Granulocyte Colony-Stimulating Factor
2016
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,420 Previous Clinical Trials
1,382,932 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,722 Patients Enrolled for Multiple Myeloma
Hackensack Meridian HealthLead Sponsor
134 Previous Clinical Trials
29,905 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,402 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03909412 — Phase 1
Multiple Myeloma Research Study Groups: Carfilzomib Mobilization - Dose Level 4, Carfilzomib Mobilization - Dose Level 3, Carfilzomib Mobilization - Dose Level 5, Carfilzomib Mobilization - Dose Level 0, Carfilzomib Mobilization - Dose Level 1, Carfilzomib Mobilization - Dose Level 2
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT03909412 — Phase 1
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03909412 — Phase 1
~1 spots leftby Dec 2024
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