RecruitingPHASE2INTERVENTIONAL

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

This study is for people with multiple myeloma, a type of blood cancer. It aims to find out if the usual bortezomib chemotherapy injection, currently given in hospital, can be safely self-administered by patients or their carers in their own homes. All tests and checks done during the study are the same as those you would normally have as part of your regular care, so there are no extra medical procedures. The main goal is to see if treating myeloma at home can be just as safe and effective, potentially making life a bit easier for patients and reducing the need for hospital trips. This approach could offer more flexibility and convenience for those receiving long-term treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AHS Cancer Control Alberta

Enrolment target

100

Start

29 May 2020

Estimated completion

01 Dec 2026

Myeloma Myeloma Multiple

What is this study about?

Currently, most chemotherapy treatments for cancers like myeloma are given in hospitals or special cancer centres. While this provides a safe environment, it can also mean a lot of travel, waiting, and time away from home for patients and their families. This study wants to explore a new way of doing things, especially for modern chemotherapy drugs that often have fewer side effects than older ones.

We already know that some similar medications for other long-term conditions, like certain types of arthritis, are safely given at home. So, we're asking: could this also be true for bortezomib, a common chemotherapy drug for myeloma? Giving treatment at home could significantly improve someone's quality of life, giving them more control over their schedule and reducing the burden of frequent hospital visits.

This study will carefully check if patients or their caregivers can be taught to safely give these injections at home. By doing this, we hope to make treatment more convenient and better suited to people's daily lives, while always making sure it's as safe and effective as receiving it in hospital.

Key takeaways

Looks at giving myeloma chemotherapy (bortezomib) at home.
Aims to make treatment more convenient for patients.
Focuses on self-administration or caregiver administration.
Only for people already familiar with bortezomib injections.
All medical checks are part of standard care, no extra tests.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or over with a diagnosis of symptomatic myeloma. It's important that your overall health is stable, as decided by your doctor. You (or a caregiver who supports you) must also be willing and able to learn how to give the bortezomib injections yourself, after being taught.

You should have already received at least four bortezomib injections in a hospital or cancer centre, so you're familiar with the treatment. Finally, you'll need to sign a consent form, showing you understand what the study involves and agree to take part.

There are also a few reasons why you might not be able to join. For example, if you're already in another clinical trial using bortezomib, or if you've had a bad allergic reaction or serious bleeding because of bortezomib in the past. Also, if your doctor thinks you might have trouble sticking to the treatment plan or if your life expectancy is thought to be less than six months, you wouldn't be able to participate. Living somewhere too far from the hospital for necessary check-ups would also exclude you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of symptomatic myeloma?
Are you (or your caregiver) willing and able to learn to give injections?
Have you already had at least 4 bortezomib injections in hospital?
Have you not had severe allergic reactions or major bleeding from bortezomib?
Is your estimated life expectancy more than 6 months?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the main change would be learning to give your bortezomib injections at home, or having a caregiver do it for you, after receiving clear training. All the medical tests and check-ups you'd have are the same as those you'd normally receive as part of your standard myeloma care. This means there are no extra medical procedures scheduled specifically for the study.

You would still have regular appointments, but some of the treatment steps would move from the hospital to your home. The total duration of your participation would depend on your individual treatment plan for myeloma, as this study integrates into your ongoing care.

Potential risks and benefits

A potential benefit of taking part is the convenience and flexibility of receiving your chemotherapy injections at home, saving you time and travel to the hospital. All tests and assessments will follow your standard care, aimed at ensuring your safety. Potential risks include the usual side effects associated with bortezomib, which your medical team will discuss with you. There's also the new aspect of learning to self-administer the injection, which comes with training and support. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Arthur J.E. Child Comprehensive Cancer Centre
Verified postcode
Calgary, Canada· Recruiting
Cross Cancer Institute
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is bortezomib?

Bortezomib is a medication used as chemotherapy to treat certain blood cancers, including myeloma.

Will I have to pay to be part of this study?

No, you will not have to pay to participate in this study. It's about finding better ways to deliver treatment within normal care.

What if I can't inject myself?

If you are not able to, or prefer not to inject yourself, a caregiver can be trained to give you the injections at home instead.

Are there extra tests because it's a study?

No, all tests and check-ups are the same ones you would normally have as part of your regular myeloma care.

Can I stop being in the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your usual medical care or treatment.

How to find out more

Jason Tay, MD

jason.tay@ahs.ca 587-231-5437 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.