Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase 2, open label, multicenter, single-stage study to evaluate the efficacy of Isatuximab plus Pomalidomide and Dexamethasone (IPd), in patients with AL amyloidosis not in VGPR or better after any previous therapy

This research is a Phase 2 study looking at a new combination of three medicines for people diagnosed with AL amyloidosis. This condition causes abnormal proteins to build up in organs. The study is particularly for patients whose amyloidosis hasn't improved much with their previous treatments. Researchers want to see if this new combination, called IPd, can reduce the amount of these abnormal proteins in the blood. They'll also be checking how patients feel and how the treatment affects their organs over time. This type of study helps doctors understand if new treatments are safe and effective before they can be used more widely.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Intergroupe Francophone Du Myelome

Enrolment target

Start

18 Nov 2024

AL Amyloidosis

What is this study about?

This study is about a health condition called AL amyloidosis. This is quite a rare condition where abnormal proteins, called amyloid, build up in different organs of the body, like the heart, kidneys, or liver. This build-up can stop these organs from working properly.

The study is testing a new treatment which is a combination of three medicines: Sarclisa, Pomalidomide (also known as Imnovid), and Dexamethasone (also known as Dectancyl or Neofordex). This combination is called IPd. It's an 'open-label' study, which means everyone involved, including the patients and doctors, will know which treatment is being given. It's also 'multicenter', meaning it's happening in several different hospitals or clinics.

The main aim of this study is to see how well this new IPd treatment works for people with AL amyloidosis, especially those who haven't fully responded to other treatments they've had before. The doctors will be looking closely at how much the abnormal proteins in the blood decrease, as this is a key sign the treatment is working. They will also look at how the treatment impacts peoples' general health, organ function, and quality of life over several months.

Key takeaways

This study tests a new combination of medicines for AL amyloidosis.
It's for people whose amyloidosis hasn't fully responded to previous treatments.
The treatment involves a drip and tablets.
Doctors will monitor blood markers, organ function, and your general well-being.
It's a Phase 2 study, aimed at understanding a treatment's effectiveness and safety.
You can discuss any concerns or questions with the study team.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with AL amyloidosis.

Crucially, you would be considered for this study if your AL amyloidosis hasn't shown a really good response to any treatments you've had in the past.

Both men and women can take part in this study. There might be other specific health checks that the study doctors will need to carry out to make sure the treatment is suitable and safe for 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?
Have you been diagnosed with AL amyloidosis?
Has your AL amyloidosis not shown a very good response to your previous treatments?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the combination of Sarclisa, Pomalidomide, and Dexamethasone. Sarclisa is given through a drip (infusion), while Pomalidomide and Dexamethasone are taken as tablets. You would generally receive this treatment and have check-ups in cycles, typically lasting for at least 6 cycles, with each cycle being a set period of time.

Throughout the study, you'll have regular visits to the hospital or clinic. These visits will involve blood tests to track the abnormal proteins and other health markers, as well as scans or tests to check how your organs are responding. Doctors will also want to know how you're feeling and whether you're experiencing any side effects from the medication. The study will continue for a set period, checking your progress at different stages, including after 6 cycles and potentially for up to a year or more, to see the long-term effects of the treatment.

Potential risks and benefits

Like all medical treatments, there may be potential benefits and potential risks to taking part in this study. The potential benefit is that this new combination of medicines might help reduce the abnormal proteins in your body and improve your AL amyloidosis, especially if previous treatments haven't worked well for you. However, there's no guarantee it will work, and you might experience side effects from the medicines, which the study team will monitor closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is AL amyloidosis?

AL amyloidosis is a rare condition where abnormal proteins, called amyloid, build up in different body organs, which can stop them from working properly.

What are the main medicines in this study?

The study uses a combination of three medicines: Sarclisa (given by drip), Pomalidomide (tablets), and Dexamethasone (tablets).

Why are they doing this study?

They want to see if this new combination of medicines can help people with AL amyloidosis, especially if their condition hasn't improved much with past treatments.

What does a 'Phase 2' study mean?

A Phase 2 study is a stage of research that looks at whether a new treatment is safe and effective in a larger group of patients, after initial safety tests.

How long will I be in the study?

If you join, you'll receive treatment and have check-ups in cycles for at least 6 cycles, with follow-ups possibly continuing for up to a year or more.