Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

ISKPD-IFM2018-03-Multicenter Open label Phase 2 study of Isatuximab plus Pomalidomide and Dexamethasone with Carfilzomib in Relapsed or Refractory Multiple Myeloma

This study is looking into a new combination of treatments for adults with multiple myeloma, a type of blood cancer, that has either returned after initial treatment or hasn't improved with other therapies. The main goal is to find out how many people achieve a very low level of cancer cells after taking these combined medicines. Researchers will also be checking for any side effects, how long people respond to the treatment, and how it impacts their overall health. The treatments being tested include Isatuximab (Sarclisa), Pomalidomide (Imnovid), Dexamethasone, and Carfilzomib (Kyprolis). It's an important step to find more effective ways to manage multiple myeloma.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Poitiers

Enrolment target

Start

19 Aug 2024

Multiple Myeloma

What is this study about?

This research study is designed for adults who have multiple myeloma. Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. In multiple myeloma, these plasma cells grow too much and can cause problems in the bones, kidneys, and immune system. The specific people this study is for are those whose multiple myeloma has either come back after being treated before (we call this 'relapsed') or hasn't gotten better with standard treatments (we call this 'refractory'). It's an important area of research because finding new and effective treatments for these situations is crucial.

The study is testing a new combination of several medicines: Isatuximab (which you might hear called Sarclisa), Pomalidomide (also known as Imnovid), Dexamethasone, and Carfilzomib (also known as Kyprolis). All of these drugs are already used to treat multiple myeloma, but this study wants to see how well they work together as a team. The main purpose is to find out if this combination can lead to a very deep response, meaning a very low level of cancer cells in the body. This is a "Phase 2" study, which means it builds on earlier research and aims to confirm the effectiveness and safety of this treatment approach in a larger group of patients.

Researchers are particularly interested in a measure called "MRD 10-5 incidence rate." MRD stands for Minimal Residual Disease, and a 10-5 level means that for every 100,000 cells tested, only one cancer cell could be found. Reaching this extremely low level of cancer cells is a very positive sign. They will also be carefully monitoring for any side effects from the treatment, how many people respond to the medicines, how long that response lasts, and how the quality of life and overall health of participants are affected. This detailed information will help doctors understand if this new combination has the potential to become a standard treatment option for multiple myeloma in the future.

Key takeaways

This study is for adults with multiple myeloma that has returned or hasn't responded to prior treatments.
It tests a new combination of four existing medicines: Sarclisa, Imnovid, Dexamethasone, and Kyprolis.
The main aim is to see if this combination can achieve very low levels of cancer cells.
Researchers will also carefully monitor side effects and how the treatment affects participants' health.
Participation involves regular clinic visits, blood tests, and receiving the study medications.
You can stop participating at any time if you wish.

Who may be eligible?

To be able to join this study, participants must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

Crucially, you must have multiple myeloma that has either returned after you've had previous treatment, or it hasn't responded to the treatments you've received so far. This study specifically targets these challenging situations where current treatments haven't been fully successful or the cancer has come back.

There will also be other specific health requirements that your doctor will discuss with you. These might include certain blood test results and general health conditions to make sure the treatment is 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 multiple myeloma?
Has your multiple myeloma come back after treatment, or not responded to previous treatments?
Are you able to attend regular clinic visits and appointments related to the study?
Are you willing to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a new combination of medicines: Imnovid (Pomalidomide) in capsule form, Dexamethasone, Kyprolis (Carfilzomib) given as an infusion into a vein, and Sarclisa (Isatuximab) also given as an infusion. The specific schedule and dose for each medicine will be decided by the study team.

Throughout the study, you will have regular visits to the clinic. These visits will involve blood tests to check how the treatment is working and to monitor your general health. You will also have physical exams and discussions with the study doctor and nurses to track any side effects or changes in your health. The study team will explain exactly how often these visits will be and what will happen during each one. The overall duration of your participation, including follow-up after the main treatment, will be clearly outlined by the study team.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and potential risks. A potential benefit of this study is that the new combination of medicines might be more effective in controlling your multiple myeloma than existing treatments, especially if your cancer has returned or hasn't responded to previous therapies. However, there's no guarantee the treatment will work for everyone, and it's possible it won't be as effective as hoped. Like all medicines, the drugs in this study can cause side effects. These could range from mild to severe, and the study team will monitor you closely for any issues and help manage them. You will be given detailed information about all known side effects before you decide to join. It is very important to remember that participating 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
France

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 do 'relapsed' or 'refractory' mean?

'Relapsed' means your multiple myeloma has come back after treatment, and 'refractory' means it hasn't responded to previous treatments.

What are the main medicines being tested?

The study is testing a combination of Isatuximab (Sarclisa), Pomalidomide (Imnovid), Dexamethasone, and Carfilzomib (Kyprolis).

What is the main goal of this study?

The main goal is to see how many people achieve a very low level of cancer cells (called MRD 10-5) with this new treatment combination.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.