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Anti-tumor antibiotic

Home-Based Chemotherapy with Bortezomib for Multiple Myeloma (EASE Trial)

Phase 2
Recruiting
Led By Jason Tay, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients are aged 18 years old or older with a diagnosis of symptomatic myeloma
Previously received more than 4 injections of bortezomib within the hospital and/or cancer centre environment
Must not have
Currently participating in clinical trials that includes the use of bortezomib
History of bleeding attributable to bortezomib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years from study start
Awards & highlights
No Placebo-Only Group

Summary

This trial is to see if bortezomib, typically given as a subcutaneous injection in a medical setting, can be safely self-administered or given by a caregiver at home.

Who is the study for?
This trial is for adults over 18 with symptomatic myeloma who've had at least four bortezomib injections in a medical setting. They must be stable, willing, and able to self-administer the drug or have a caregiver do it. People can't join if they're not likely to follow treatment, have less than six months to live, are hard to reach for care, allergic to bortezomib, in another bortezomib study, or had severe side effects from it before.
What is being tested?
The trial tests if patients with multiple myeloma or plasma cell neoplasms can safely give themselves the chemotherapy drug bortezomib at home. It's checking whether this approach is as safe as when given in a hospital by healthcare professionals.
What are the potential side effects?
Bortezomib may cause side effects like nausea, diarrhea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Some people might experience nerve damage resulting in pain or numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older with diagnosed symptomatic myeloma.
Select...
I have had more than 4 bortezomib injections in a hospital or cancer center.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not in a clinical trial using bortezomib.
Select...
I have had bleeding problems due to bortezomib.
Select...
I have experienced severe side effects from bortezomib.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years from study start
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years from study start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events great than grade 3
Myeloma response outcomes
Number of patients able to self-administer
+4 more

Side effects data

From 2022 Phase 2 trial • 248 Patients • NCT02654990
65%
Diarrhoea
55%
Thrombocytopenia
42%
Anaemia
37%
Nausea
35%
Fatigue
32%
Neutropenia
32%
Asthenia
29%
Oedema Peripheral
27%
Constipation
26%
Upper Respiratory Tract Infection
26%
Neuropathy Peripheral
21%
Peripheral Sensory Neuropathy
21%
Vomiting
18%
Hypokalaemia
17%
Respiratory Tract Infection
17%
Decreased Appetite
17%
Dizziness
15%
Cough
15%
Abdominal Pain Upper
14%
Platelet Count Decreased
14%
Urinary Tract Infection
14%
Dyspnoea
13%
Pyrexia
12%
Dyspepsia
12%
Bronchitis
12%
Blood Creatinine Increased
12%
Back Pain
12%
Pain in Extremity
10%
Pneumonia
10%
Alanine Aminotransferase Increased
9%
Hypocalcaemia
9%
Headache
9%
Insomnia
9%
Hypotension
9%
Hyponatraemia
8%
Cataract
8%
Hypophosphataemia
8%
Hypertension
8%
Weight Decreased
8%
Epistaxis
6%
Abdominal Pain
6%
Leukopenia
6%
Conjunctivitis
6%
Aspartate Aminotransferase Increased
6%
Bone Pain
6%
Muscular Weakness
6%
Alopecia
5%
Non-cardiac Chest Pain
5%
Hyperglycaemia
5%
Flatulence
5%
Respiratory Tract Infection Viral
5%
C-Reactive Protein Increased
5%
Neutrophil Count Decreased
5%
White Blood Cell Count Decreased
5%
Paraesthesia
5%
Depression
5%
Dysphonia
5%
Oropharyngeal Pain
4%
Dehydration
4%
Musculoskeletal Pain
4%
Lower Respiratory Tract Infection
4%
Arthralgia
4%
Polyneuropathy
3%
Musculoskeletal Chest Pain
3%
Gastroenteritis
3%
Nasopharyngitis
3%
Weight Increased
3%
Rash
1%
Transfusion-related Acute Lung Injury
1%
Cerebrovascular Accident
1%
Chronic Obstructive Pulmonary Disease
1%
Pneumonia Aspiration
1%
Drug Withdrawal Syndrome
1%
Forearm Fracture
1%
Subdural Haematoma
1%
Syncope
1%
Obstructive Airways Disorder
1%
Meningitis
1%
Muscle Spasms
1%
Type 2 Diabetes Mellitus
1%
Atrial Fibrillation
1%
Cardiac Failure
1%
Cardiac Failure Congestive
1%
Atrial Flutter
1%
Pneumonia Parainfluenza Viral
1%
Sepsis
1%
Bacterial Pyelonephritis
1%
Infection
1%
Pyelonephritis
1%
Troponin Increased
1%
Diabetes Mellitus
1%
Hypoglycaemia
1%
Gastrointestinal Tract Adenoma
1%
Acute Kidney Injury
1%
Pulmonary Embolism
1%
Pulmonary Haemorrhage
1%
Skin Ulcer
1%
Circulatory Collapse
1%
Peripheral Ischaemia
1%
Influenza
1%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A - Panobinostat (20 mg, TIW)
Arm B - Panobinostat (20 mg, BIW)
Arm C - Panobinostat (10 mg, TIW)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Self Injection of BortezomibExperimental Treatment1 Intervention
Subcutaneous self administration of bortezomib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib Injection
2018
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer CentreUNKNOWN
Tom Baker Cancer CentreOTHER
29 Previous Clinical Trials
8,825 Total Patients Enrolled
1 Trials studying Multiple Myeloma
19 Patients Enrolled for Multiple Myeloma
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
26,731 Total Patients Enrolled
2 Trials studying Multiple Myeloma
1,094 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib Injection (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04268199 — Phase 2
Multiple Myeloma Research Study Groups: Self Injection of Bortezomib
Multiple Myeloma Clinical Trial 2023: Bortezomib Injection Highlights & Side Effects. Trial Name: NCT04268199 — Phase 2
Bortezomib Injection (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04268199 — Phase 2
~8 spots leftby May 2025
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