Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM

This UK-based study, called ALUMMINATE RRMM, is investigating a new medication named Alnuctamab for adults with multiple myeloma. This is for people whose cancer has either returned after previous treatment or isn't responding to it anymore. The main goal is to see if Alnuctamab can stop the cancer from getting worse for a longer time compared to standard treatments currently available. Researchers will also be checking how long people live overall, how well their cancer responds to the new drug, and what side effects they might experience. This is a Phase 3 study, meaning it's a key step to confirm if Alnuctamab is truly effective and safe before it could potentially become a widely available treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Celgene International II S.a.r.l.

Enrolment target

177

Start

16 Apr 2024

Relapsed and/or Refractory Multiple Myeloma

What is this study about?

This study is looking at a new medicine called Alnuctamab. It's designed for people in the UK who have multiple myeloma, a type of blood cancer. Specifically, it's for those whose cancer has returned after treatment, or hasn't responded well to the treatments they've already had. The study wants to find out if Alnuctamab is better at controlling the cancer and is safe to use, compared to the medicines doctors usually prescribe in these situations.

The main thing the researchers want to measure is how long people live without their cancer getting worse. They call this "progression-free survival." This means they'll track the time from when a patient starts taking the study medicine until their cancer shows signs of growing again, or if they pass away for any reason. If Alnuctamab can extend this period, it would be a very positive outcome.

Besides how long the cancer is kept under control, the study will also look at other important things. This includes how long people live overall, how well the cancer shrinks or stops growing with the new medicine, and any side effects people might have. They will also look at how the treatment affects a person's general well-being and quality of life. All of this information helps doctors understand if Alnuctamab could be a valuable new treatment option for multiple myeloma.

Key takeaways

This study is testing a new medicine, Alnuctamab, for multiple myeloma.
It's for people whose cancer has come back or isn't responding to current treatments.
The main goal is to see if Alnuctamab stops cancer growth for longer than usual treatments.
Researchers will also track overall survival and side effects.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. Both men and women can take part.

The study is specifically for people whose multiple myeloma has either come back after they've had previous treatments, or if their cancer hasn't responded to the treatments they've already received. Doctors will check your medical history and current health carefully to make sure the study is a good fit for you.

There might be other health requirements or previous treatments you've had that would make you suitable or unsuitable for this study. Your doctor will discuss all of these details with you to see if you meet the specific criteria set by the researchers.

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 multiple myeloma?
Has your multiple myeloma come back after treatment, or is it not responding?
Are you prepared to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new medicine, Alnuctamab, or one of the standard treatments currently used for multiple myeloma. This will be decided randomly, like flipping a coin. You will have regular visits to your clinic or hospital for check-ups and to receive your medication. These visits will involve blood tests, physical examinations, and other assessments to see how you're responding to the treatment and to monitor for any side effects.

The length of your participation will depend on how well you respond to the treatment and if you experience any side effects. You will continue with the study treatment for as long as it is helping you and is safe. Even after you stop the study treatment, there will be follow-up visits or phone calls to monitor your long-term health. Your doctor will explain the full schedule of visits and what each will involve, as well as the total expected duration of your participation.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new investigative treatment (Alnuctamab) that could potentially control your multiple myeloma for longer or be more effective than current standard options. However, like all medications, the study treatments, including Alnuctamab, can have side effects, some of which may be serious or unexpected. Your medical team will monitor you closely for any reactions and will do their best to manage them. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

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

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Unverified
Germany
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Unverified
Italy
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Unverified
Sweden
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Unverified
Romania
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Unverified
Ireland
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Unverified
Czechia
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Unverified
Spain
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Unverified
France
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Unverified
Hungary
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Unverified
Portugal
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Unverified
Belgium
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Unverified
Austria

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in plasma cells, which are a kind of white blood cell found in your bone marrow. These cells are important for your immune system.

What does 'relapsed or refractory' mean?

This means your multiple myeloma has either come back (relapsed) after you've had treatment, or it hasn't responded to treatments you've tried (refractory).

What is Alnuctamab?

Alnuctamab is the name of the new medicine being tested in this study. Researchers are hoping it can help treat multiple myeloma.

What is a 'Phase 3' study?

Phase 3 is an important stage in testing new medicines. It means the medicine has already shown some promise in earlier studies, and now researchers want to confirm its effectiveness and safety in a larger group of people.

Will I definitely get the new medicine?

Not necessarily. In this type of study, participants are usually randomly assigned to receive either the new medicine or one of the standard treatments. Your doctor will explain how this works.