Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

KRd consolidation in myeloma patients with a positive PET-CT after standard first line treatment. A phase II study

This study is for people with multiple myeloma, a type of blood cancer, who have already had their first standard treatment. After this initial treatment, doctors use a special scan called a PET-CT. If this scan still shows signs of cancer, patients in this study will receive additional treatment using a combination of medicines called KRd (Kyprolis, Revlimid, and dexamethasone). The main goal is to find out how many patients will have a clear PET-CT scan after taking KRd for four cycles. We will also check if this treatment is safe, how well it works overall, how long people stay well without their cancer getting worse, and how their quality of life is during and after the treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oslo University Hospital HF

Enrolment target

Start

04 Oct 2024

Multiple Myeloma

What is this study about?

This study, called a Phase II study, is investigating a new approach for people with multiple myeloma. Multiple myeloma is a cancer that affects the plasma cells in your bone marrow. When you're first diagnosed, you usually receive standard treatments to try and get rid of as much cancer as possible.

After this initial treatment, doctors use a special type of scan called a PET-CT. This scan helps to see if there are still signs of active cancer in your body. If the PET-CT scan still shows some cancer, this study aims to see if adding extra treatment, called "consolidation," using a combination of medications known as KRd, can help clear up these remaining cancer signs. KRd stands for Kyprolis (carfilzomib), Revlimid (lenalidomide), and dexamethasone.

Researchers will be looking at several important things. Firstly, they want to see how many patients who still have some cancer showing on their PET-CT after standard treatment can then achieve a clear, or "negative," PET-CT scan after four cycles of KRd. They will also be tracking how safe the treatment is, how well patients respond to it, how long they live without the cancer getting worse, and how the quality of their life is affected while on the study and afterwards. This research helps doctors understand if this KRd treatment could be a good next step for patients who still have signs of cancer after their first round of treatment.

Key takeaways

This study is for multiple myeloma patients who still have signs of cancer after their first treatment.
It tests if a treatment called KRd can make these cancer signs disappear from scans.
KRd involves three different medications: Kyprolis, Revlimid, and dexamethasone.
Researchers will check how well KRd works, if it's safe, and its impact on quality of life.
Participation includes receiving KRd for four cycles and regular health check-ups.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You would be considered for this study if you have multiple myeloma and have already completed your first standard course of treatment for your cancer.

Crucially, after your first treatment, a special scan called a PET-CT needs to show that there are still some signs of active cancer. This study is specifically looking at patients who still have some cancer detected by this scan.

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?
Have you already completed your first standard treatment for multiple myeloma?
Did a PET-CT scan after your first treatment still show some signs of active cancer?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will first have a PET-CT scan to confirm that there are still signs of cancer after your initial treatment. If this is the case, you will then receive the KRd treatment combination for four cycles. This involves taking lenalidomide (a pill), receiving Kyprolis (an infusion into your vein), and taking dexamethasone (a pill or injection). You will have regular visits to the clinic for your treatments and to have blood tests and other check-ups to monitor your health and how you are responding to the treatment.

At the end of the four cycles of KRd, you will have another PET-CT scan to see if the treatment has cleared up the signs of cancer. You will also have additional tests, including bone marrow biopsies to check for very small amounts of cancer cells (called MRD). The study will also follow your health over time to see how you are doing, including tracking how long it is before any further treatment is needed and your general well-being. The total duration of active treatment with KRd will be four cycles, but you will be monitored for a longer period afterwards.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a focused treatment aiming to clear up any remaining cancer after your initial therapy, which might lead to better disease control. However, like all medical treatments, KRd can have side effects. These can range from mild to more serious, and the study team will explain these in detail. You will be closely monitored for any side effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Denmark
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Unverified
Norway

Common questions

What is multiple myeloma?

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

What is a PET-CT scan?

A PET-CT scan is a special imaging test that helps doctors find areas of active cancer in your body. 'Positive' means it shows signs of cancer, 'negative' means it doesn't.

What are KRd and what do the letters stand for?

KRd is a combination of three medicines: Kyprolis (carfilzomib), Revlimid (lenalidomide), and dexamethasone. They are used together to treat multiple myeloma.

What does 'consolidation' mean in this study?

Consolidation treatment means giving extra therapy after your first main treatment, aiming to further reduce or eliminate any remaining cancer cells.

How long will I be on the KRd treatment if I join?

If you join, you will receive the KRd treatment for four cycles. Each cycle is a specific period of time with treatment days and rest days.