Carfilzomib for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Loyola University Medical Center, Maywood, ILMultiple MyelomaCarfilzomib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a combination of drugs is an effective preparative regimen for people with multiple myeloma who are candidates for autologous stem cell transplantation. The combination being tested is busulfan and melphalan with carfilzomib. They will compare the results to historical controls of people treated with melphalan, busulfan and bortezomib.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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BEM vs BEM + Ruzasvir n=16

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: 3 years

100 days
36 participants evaluated by oral exam to assess mucositis events and grading levels by using CTCAE v4.0.
36 participants evaluated by the liver to assess Veno-occlusive disease and grading levels by using CTCAE v4.0.
36 participants evaluated for absolute neutrophil count by testing white blood cells levels.
36 participants evaluated for platelet engraftment by testing platelet count in blood cells.
36 participants evaluated for response to treatment by testing blood for multiple myeloma levels.
36 participants evaluated for response to treatment by testing urine for multiple myeloma levels.
3 years
36 participants evaluated by a physical exam to assess peripheral neuropathy and grading by using CTCAE v4.0.
36 participants evaluated for overall survival by clinical visit or contact by phone.
36 participants evaluated for progression by testing blood for multiple myeloma levels.
Multiple Myeloma
36 participants evaluated for safety with treatment-related adverse events and grading by using CTCAE v4.0.
36 participants evaluated for tolerability with treatment-related adverse events and grading by using CTCAE v4.0.

Trial Safety

Safety Progress

1 of 3

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1
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1
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1
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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%Diarrhoea
17%Hyperuricaemia
16%Blood lactate dehydrogenase increased
16%Hypoalbuminaemia
16%Hypocalcaemia
16%Neutrophil count increased
15%Blood uric acid increased
15%Lung infection
15%Blood pressure increased
14%Blood glucose increased
14%White blood cell count increased
14%Blood bilirubin increased
14%Hyperglycaemia
14%Constipation
12%Neutrophil percentage increased
12%Blood urea increased
11%Hyponatraemia
11%Alanine aminotransferase increased
11%Hypercalcaemia
10%Lymphocyte percentage decreased
10%Bronchitis
10%Neuropathy peripheral
10%Oedema peripheral
10%Productive cough
10%Blood potassium decreased
10%Aspartate aminotransferase increased
9%Leukocytosis
8%Blood phosphorus increased
8%Hypoproteinaemia
8%Blood albumin decreased
8%Influenza
7%Prealbumin decreased
7%Hypophosphataemia
7%Bilirubin conjugated increased
7%Mean cell volume increased
7%Cataract
7%Back pain
7%Vomiting
7%Peripheral swelling
7%Nasopharyngitis
7%Abdominal distension
6%Thrombocytopenia
6%Respiratory tract infection
6%Hypoglycaemia
6%Vision blurred
6%Nausea
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%Cerebral ischaemia
1%Disease progression
1%Pain
1%Soft tissue infection
1%Spinal compression fracture
1%Interstitial lung disease
1%Device related infection
1%Periodontitis
1%Pleural effusion
1%Lipoma
1%Dysuria
1%Otitis media
1%Organising pneumonia
1%Obstructive airways disorder
1%Infusion site extravasation
1%Asthma
1%Pathological fracture
1%Nerve compression
1%Pancreatitis acute
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
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03029234) in the Carfilzomib With Dexamethasone ARM group. Side effects include: Anaemia with 62%, Platelet count decreased with 49%, Upper respiratory tract infection with 49%, White blood cell count decreased with 39%, Hypertension with 38%.

Trial Design

5 Treatment Groups

Carfilzomib IV at dose: 56 mg/m2
1 of 5
Carfilzomib IV at dose: 45 mg/m2
1 of 5
Carfilzomib IV at dose: 20 mg/m2
1 of 5
Carfilzomib IV at dose: 27 mg/m2
1 of 5
Carfilzomib IV at dose: 36 mg/m2
1 of 5

Experimental Treatment

36 Total Participants · 5 Treatment Groups

Primary Treatment: Carfilzomib · No Placebo Group · Phase 1 & 2

Carfilzomib IV at dose: 56 mg/m2Experimental Group · 3 Interventions: Carfilzomib, Busulfan IV, Melphalan IV · Intervention Types: Drug, Drug, Drug
Carfilzomib IV at dose: 45 mg/m2Experimental Group · 3 Interventions: Carfilzomib, Busulfan IV, Melphalan IV · Intervention Types: Drug, Drug, Drug
Carfilzomib IV at dose: 20 mg/m2Experimental Group · 3 Interventions: Carfilzomib, Busulfan IV, Melphalan IV · Intervention Types: Drug, Drug, Drug
Carfilzomib IV at dose: 27 mg/m2Experimental Group · 3 Interventions: Carfilzomib, Busulfan IV, Melphalan IV · Intervention Types: Drug, Drug, Drug
Carfilzomib IV at dose: 36 mg/m2Experimental Group · 3 Interventions: Carfilzomib, Busulfan IV, Melphalan IV · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Loyola UniversityLead Sponsor
148 Previous Clinical Trials
30,322 Total Patients Enrolled
1 Trials studying Multiple Myeloma
3 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,301 Previous Clinical Trials
1,330,141 Total Patients Enrolled
95 Trials studying Multiple Myeloma
20,593 Patients Enrolled for Multiple Myeloma
Patrick Stiff, MDPrincipal Investigator - Loyola University
Loyola University Medical Center, St. Joseph Regional Medical Center
Loyola University Of Chicago Stritch School Of Medicine (Medical School)
Cleveland Clinic Fndn (Residency)
8 Previous Clinical Trials
415 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What medical conditions can be addressed through the use of Carfilzomib?

"Carfilzomib is widely used for allogeneic hematopoietic stem cell transplant and chronic myelogenous leukemia. Additionally, it may be prescribed to aid those suffering from amyloidosis, thrombocythemia, essential, refractory multiple myeloma." - Anonymous Online Contributor

Unverified Answer

To what extent is participation being sought for this medical investigation?

"Indeed, clinicaltrials.gov verifies that this trial is actively seeking volunteers for participation. With its initial launch on May 22nd 2019 and latest update on April 23rd 2021, the study currently needs 36 individuals to sign up from a single site." - Anonymous Online Contributor

Unverified Answer

Are there any openings available for potential participants in this scientific trial?

"Clinicaltrials.gov confirms that this medical trial is engaging participants, having been first posted on May 22nd 2019 and most recently edited on April 23rd 2021." - Anonymous Online Contributor

Unverified Answer

What are the objectives of this research endeavor?

"Amgen, the study sponsor for this trial, has reported that their primary outcome of interest will be assessed over a three-year period. This involves measuring 36 participants' tolerability and any adverse reactions through CTCAE v4.0. Additionally, secondary outcomes including Veno-occlusive disease grading levels by using CTCAE v4.0., urine tests to determine response rates in complete/very good partial/partial no stable disease patients, and blood tests assessing Progression Free Survival are also being monitored during the study's duration." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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