RecruitingNAINTERVENTIONAL

PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and/or Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.

The PASCA-MM study is for adults aged 18 to 70 in the UK who have multiple myeloma and are receiving a stem cell transplant. This research explores if a special care program called PASCA can better manage or prevent common health problems that can come up because of multiple myeloma or its treatments. Half of the participants will receive this new PASCA care plan, which involves early check-ups and quick access to specialists based on their individual needs. The other half will receive standard care, where their regular doctors will manage any issues. Everyone will have regular health checks for two years after their stem cell transplant. The aim is to find out if the PASCA program makes a difference in keeping people healthier.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Leon Berard

Enrolment target

204

Start

19 Jan 2024

Estimated completion

14 Sep 2027

Multiple Myeloma Complication

What is this study about?

This study is called the PASCA-MM study, and it's looking into a new way of caring for people with a type of blood cancer called multiple myeloma. Multiple myeloma and its treatments, especially after a stem cell transplant, can sometimes lead to different health problems. This study wants to find out if a specific new program, called PASCA (which stands for 'Path of Health During Cancer' in French), can help to spot and manage these problems earlier on.

About 1 in 20,000 people are diagnosed with multiple myeloma in the UK each year. The PASCA program involves regular health checks and, if any problems are found, quickly connecting patients with the right healthcare professionals. This is different from the usual care, where your specialist might not get all the details as quickly or have the same network to refer you to straight away. The study is comparing the PASCA program with the usual care to see if it improves how well people manage after their stem cell transplant.

To make sure the study is fair, participants will be split into two groups by chance (like flipping a coin). One group will get the PASCA program, and the other will receive the usual care. Both groups will have regular check-ups over two years after their stem cell transplant to monitor their health. This will help doctors understand if the new PASCA approach is better at preventing or dealing with complications and ultimately helping people feel better and stay healthier.

Key takeaways

This study compares a new care program (PASCA) with standard care for multiple myeloma.
It aims to reduce health problems after a stem cell transplant.
Participants will have regular health checks for two years.
You'll be randomly assigned to either the PASCA group or the standard care group.
The study doesn't involve new medications, but a different way of managing your care.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults between 18 and 70 years old who have been diagnosed with multiple myeloma. You would need to be getting a specific type of stem cell transplant (called an autologous hematopoietic stem cell transplant, where you receive your own stem cells). Also, your multiple myeloma needs to be responding well to treatment before the transplant.

There are a few other important things to consider. You should be in good general health, and your physical ability shouldn't be significantly impacted by your illness. You also need to live in certain areas of France (Auvergne-Rhône-Alpes or Saône-et-Loire department) and be able to understand, read, and write French.

However, you wouldn't be able to join if you have another type of cancer (except for a common skin cancer called basal cell cancer). You also can't take part if you are pregnant or breastfeeding, unable to attend all study appointments, or unable to give your informed consent freely.

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 between 18 and 70 years old?
Do you have multiple myeloma and are eligible for a stem cell transplant?
Is your myeloma responding well to treatment before the transplant?
Are you able to attend all study appointments over two years?
Do you live in the Auvergne-Rhône-Alpes region or Saône-et-Loire department in France?
Can you understand, read, and write in French?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be in it for about two years after your stem cell transplant. You'll be randomly put into one of two groups. One group will receive the special PASCA care plan, which means that after your check-ups, a team will quickly look at your results, explain them to you over the phone, and connect you with specialists if needed. The other group will receive standard care, where your regular cancer doctor will get your results and decide on any next steps.

Regardless of which group you are in, you will have four main check-up appointments over the two years after your transplant. These appointments will happen at roughly 1-2 months, 4 months, 14 months, and 24 months after your procedure. These visits will be when the study team checks for 7 main health problems and 13 other potential issues. You won't need to take any new medications just for this study; it's about how your care is managed and guided.

Potential risks and benefits

Taking part in this study may offer some potential benefits, particularly if you are in the PASCA group, as you might receive earlier detection and quicker access to specialist care for any health problems that arise. For all participants, the regular health checks mean you will be closely monitored. There are unlikely to be major risks beyond those associated with your usual medical appointments and treatments for multiple myeloma. You will not be taking any new experimental drugs. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in your bone marrow.

What is a stem cell transplant?

It's a medical treatment that replaces damaged bone marrow with healthy stem cells, often used for certain cancers like multiple myeloma.

What does 'randomised' mean?

It means you'll be put into one of the study groups by chance, like drawing names from a hat, to make the comparison fair.

Will I have to pay to be in the study?

No, you should not incur additional costs for participating in the study.

What if I change my mind about participating?

You are free to leave the study at any time without it affecting your medical care.

How to find out more

Romain BUONO, PharmaD, MPH

romain.buono@lyon.unicancer.fr +33469856358 Official trial record

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