Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Allogeneic stem cell transplantation vs. conventional therapy as salvage therapy for relapsed / progressive patients with multiple myeloma after a first-line therapy

This study is for people in the UK with a blood cancer called multiple myeloma. It focuses on patients whose cancer has returned or gotten worse after their initial treatment. We want to see if a special type of stem cell transplant, where cells come from a donor (allogeneic stem cell transplantation), is more effective than the usual treatments. This trial is in its most advanced stage (Phase III). Researchers will follow participants for five years to compare how long people live and their quality of life. The goal is to find out which treatment helps patients live longer and healthier lives after their first treatment for multiple myeloma hasn't worked as hoped.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

University Medical Center Hamburg-Eppendorf

Enrolment target

400

Start

02 Sep 2024

multiple myeloma

What is this study about?

This study is looking at a type of blood cancer called multiple myeloma. If you have been treated for multiple myeloma once, and the cancer has since come back or started to get worse, this study might be for you. We want to compare a special treatment called an allogeneic stem cell transplant with the standard treatments currently available.

An allogeneic stem cell transplant involves using healthy stem cells from a donor. The aim is to replace your unhealthy cells with these new, healthy ones. The study will look closely at how long people live after receiving either the stem cell transplant or conventional (standard) treatments. We will follow participants for five years to understand the long-term effects of each approach.

In addition to looking at how long people live, we'll also be checking how long they stay free from their cancer worsening, and how their quality of life changes over time. Your quality of life means how you feel on different levels, like your physical health and general well-being. This study is important because it could help us find better ways to treat multiple myeloma when it returns.

Key takeaways

This study compares a special stem cell transplant with standard treatments for multiple myeloma.
It's for people whose multiple myeloma has returned or worsened after their first treatment.
The study will follow participants for five years to assess survival and quality of life.
It aims to find better long-term treatment options for multiple myeloma.
Several different approved medicines may be used as part of the standard treatment.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for adults, aged 18 and over, who have multiple myeloma.

To be considered for this study, your multiple myeloma must have either returned or progressed (gotten worse) after you've already had your first course of treatment for it.

Both men and women can participate in this study. The medical team will check your specific health details to see if this study is a good fit 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?
Do you have multiple myeloma?
Has your multiple myeloma come back or gotten worse after your first treatment?
Are you able to commit to several years of follow-up appointments?
Are you prepared to potentially receive a stem cell transplant from a donor?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to either receive an allogeneic stem cell transplant or continue with standard treatments. The standard treatments include various approved medicines for multiple myeloma, such as Imnovid, Sarclisa, Darzalex, Revlimid, and specific forms of Fortecortin, among others. These will be given as capsules, tablets, or injections/infusions, depending on the specific medication.

Your participation will involve regular check-ups and assessments to monitor your health and the effectiveness of your treatment. These will include blood tests and other examinations. You will be followed closely for at least five years from when you start the study. During this time, your medical team will keep track of how you are doing, including if your cancer progresses, relapses, or if you experience any other health events. The exact number and frequency of visits will be explained by the study team.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. You might benefit from a new treatment approach that could be more effective than current standard care. However, any medical treatment, especially stem cell transplants, can have side effects. The study team will explain all known risks associated with the treatments thoroughly. 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)

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

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Unverified
Germany

Common questions

What is multiple myeloma?

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

What is an allogeneic stem cell transplant?

This is a treatment where you receive healthy stem cells from another person (a donor) to help your body make new blood cells.

What does 'relapsed/progressive' mean?

It means your multiple myeloma has either come back or started to get worse after your initial treatment.

What does a 'Phase III' study mean?

Phase III means this is the final stage of testing for new treatments, comparing them to existing standard treatments to see which is better.

Will I have to pay for the treatments in the study?

Generally, treatments given as part of a clinical trial are covered by the study sponsor. This will be confirmed by the study team.