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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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%

Hyperuricaemia

17%

Diarrhoea

16%

Hypocalcaemia

16%

Neutrophil count increased

16%

Hypoalbuminaemia

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%

Blood potassium decreased

10%

Oedema peripheral

10%

Neuropathy peripheral

10%

Productive cough

10%

Aspartate aminotransferase increased

10%

Lymphocyte percentage decreased

Leukocytosis

Hypoproteinaemia

Influenza

Blood albumin decreased

Blood phosphorus increased

Peripheral swelling

Back pain

Hypophosphataemia

Mean cell volume increased

Prealbumin decreased

Bilirubin conjugated increased

Vomiting

Abdominal distension

Cataract

Nasopharyngitis

Hypoglycaemia

Gamma-glutamyltransferase increased

Thrombocytopenia

Hyperkalaemia

Hepatic function abnormal

Respiratory tract infection

Nausea

Vision blurred

Plasma cell myeloma

Acute kidney injury

Bone pain

Localised infection

Cardiac amyloidosis

Hypotension

Obstructive airways disorder

Interstitial lung disease

Pleural effusion

Deep vein thrombosis

Myelopathy

Chronic kidney disease

Organising pneumonia

Myolipoma

Neuralgia

Asthma

Lipoma

Cerebral ischaemia

Nerve compression

Disease progression

Infusion site extravasation

Escherichia sepsis

Otitis media

Periodontitis

Pathological fracture

Pain

Device related infection

Dysuria

Soft tissue infection

Spinal compression fracture

Cardiac failure acute

Supraventricular tachycardia

Bronchiolitis

Pancreatitis acute

100%

80%

60%

40%

20%

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

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

~1430

Cyclophosphamide

2010

Completed Phase 4

~2310