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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

CarMob Trial 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.Check my eligibility
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.See study design
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.

CarMob Trial 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.
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I agree to use two effective birth control methods if I'm sexually active.
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I agree not to donate sperm during and for 3 months after my carfilzomib treatment.

CarMob Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
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%
White blood cell count increased
14%
Blood bilirubin 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 phosphorus increased
8%
Blood albumin decreased
8%
Hypoproteinaemia
8%
Influenza
7%
Prealbumin decreased
7%
Peripheral swelling
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%
Hypotension
1%
Dysuria
1%
Pathological fracture
1%
Myelopathy
1%
Nerve compression
1%
Chronic kidney disease
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Lipoma
1%
Periodontitis
1%
Asthma
1%
Spinal compression fracture
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

CarMob 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
~1440
Cyclophosphamide
1995
Completed Phase 3
~3780
Dexamethasone
2007
Completed Phase 4
~2590
Granulocyte Colony-Stimulating Factor
2016
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,226 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,402 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,362 Previous Clinical Trials
1,385,253 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,728 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 5, Carfilzomib Mobilization - Dose Level 4, Carfilzomib Mobilization - Dose Level 0, Carfilzomib Mobilization - Dose Level 1, Carfilzomib Mobilization - Dose Level 2, Carfilzomib Mobilization - Dose Level 3
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

Frequently Asked Questions

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

Are there any records of prior investigations involving Carfilzomib?

"Currently, 1367 trials for Carfilzomib are in progress with 288 taking place at the advanced Phase 3 level. While most of those studies originate from Philadelphia, Pennsylvania there is a total of 432 locations around the world conducting research on this drug."

Answered by AI

Are new participants able to join this medical trial at this time?

"Details on clinicaltrials.gov demonstrate that this investigation is looking for contributors at present. It was initially published on October 8th 2019 and the most recent update took place August 5th 2022."

Answered by AI

What is the maximum capacity of participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov has information indicating that recruitment for this research project is ongoing, as evidenced by its initial post date of October 8th 2019 and last update on August 5th 2022. 18 participants are being sought from a single location."

Answered by AI

Has Carfilzomib been sanctioned by the FDA?

"Carfilzomib's safety is assessed with a score of 1, as this phase one trial has limited clinical data to support its efficacy and security."

Answered by AI

What health issues does Carfilzomib typically address?

"Carfilzomib is used to mitigate the effects of synovitis, ophthalmia, sympathetic disorders, and lung cancers."

Answered by AI
Recent research and studies
~2 spots leftby Dec 2024