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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years from study start

Awards & highlights

EASE Trial 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.Check my eligibility

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.See study design

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.

EASE Trial 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.

EASE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years from study start

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events great than grade 3

Myeloma response outcomes

Number of patients able to self-administer

+4 more

EASE 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

~210

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tom Baker Cancer CentreOTHER

29 Previous Clinical Trials

8,755 Total Patients Enrolled

1 Trials studying Multiple Myeloma

19 Patients Enrolled for Multiple Myeloma

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,112 Total Patients Enrolled

2 Trials studying Multiple Myeloma

1,094 Patients Enrolled for Multiple Myeloma

Jason Tay, MDPrincipal InvestigatorTom Baker Cancer Centre

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

Frequently Asked Questions

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

Has this intervention been officially recognized by the FDA?

"It has been assigned a score of 2, indicating that while there is evidence backing the safety profile of this treatment, its efficacy remains to be tested."

Answered by AI

Are there any open slots available for potential participants in this experiment?

"According to clinicaltrials.gov, this research is actively recruiting participants with the initial post dating back to May 29th 2020 and the last edit occurring on May 4th 2022."

Answered by AI

How many individuals are enrolled as participants in this research?

"Affirmative. Documentation accessible via clinicaltrials.gov shows that this research initiative, which was first advertised on May 29th 2020, is currently seeking applicants. The trial is looking to enrol 100 test subjects from one single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment

2020. "A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04268199.

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