Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A PHASE 2, MULTI-COHORT, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BB2121 IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA AND IN SUBJECTS WITH CLINICAL HIGH-RISK MULTIPLE MYELOMA

This study, called a Phase 2 trial, is looking at a treatment named idecabtagene vicleucel (also known as BB2121) for multiple myeloma. It's for people whose myeloma has returned after previous treatments or hasn't responded well (this is called 'relapsed and refractory multiple myeloma'). It also includes some people with high-risk multiple myeloma. The main aims are to find out how many people respond to the treatment and to check for any side effects. This type of study helps doctors understand if new treatments are promising enough to move on to larger trials and eventually become available to more patients, offering new hope for those living with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Celgene Corp.

Enrolment target

Start

12 Feb 2024

Relapsed and refractory multiple myeloma (RRMM)

What is this study about?

This study is looking into a new treatment called idecabtagene vicleucel, sometimes shortened to 'ide-cel' or known as BB2121. It's for patients with multiple myeloma, a type of blood cancer. Specifically, it's for those whose myeloma has either come back after past treatments (relapsed) or hasn't responded well to treatment (refractory). It also includes some patients who are considered to have 'high-risk' multiple myeloma, such as those whose cancer got worse quickly after their first treatment or didn't respond well to a stem cell transplant.

The main goal of this study is to see how many patients respond to idecabtagene vicleucel. This means they are looking at whether the treatment shrinks the cancer or makes it disappear. They also want to understand the safety of the treatment and what side effects people might experience. By gathering this information, researchers can decide if ide-cel is an effective and safe option that could help more people with multiple myeloma.

Studies like this are an important step in developing new medicines. They help doctors find better ways to treat illnesses and improve the lives of patients. If this treatment proves to be safe and effective, it could offer a new hope for people living with multiple myeloma, especially for those who have limited treatment options left.

Key takeaways

This study evaluates a new treatment, idecabtagene vicleucel, for multiple myeloma.
It's for people whose myeloma has returned or not responded to previous treatments, and some high-risk cases.
The main goals are to check how well the treatment works and if it's safe.
Participation involves regular hospital visits for monitoring and assessments.
This is a Phase 2 study, an important step in developing new medicines.
Your health and safety will be closely monitored throughout the study.

Who may be eligible?

To join this study, people need to meet certain conditions. It's for adults aged 18 and over, with no upper age limit. Both men and women can take part.

Crucially, participants must have multiple myeloma that has either returned after previous treatments or hasn't responded to them. Some people with a high-risk form of newly diagnosed multiple myeloma might also be considered if their condition got worse quickly after their initial treatment or if they didn't respond well to a stem cell transplant.

There will be other specific health requirements that the study doctors will check to make sure the trial is safe and appropriate for you. Your doctor can help determine if this study might be a good fit for your individual situation.

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?
If newly diagnosed, did your multiple myeloma get worse quickly after initial treatment or not respond well to a stem cell transplant?
Are you able to attend regular hospital visits for check-ups and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the new treatment, idecabtagene vicleucel. This study is described as 'open-label', which means both you and your doctors will know you are receiving this specific treatment. You will have regular visits to the hospital or clinic, where the study team will carry out various tests and assessments. These will help them monitor your health, check how well the treatment is working, and look for any side effects.

These assessments typically include blood tests, physical examinations, and possibly imaging scans. The doctors will also routinely ask about your well-being and any symptoms you might be experiencing. The overall duration of your participation, including follow-up, will depend on how you respond to the treatment and what the study protocol dictates, but these types of studies usually involve several months of active treatment and follow-up, possibly extending for longer to monitor long-term effects.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and contributing to medical knowledge that could help others. However, there are also potential risks; new treatments can have side effects, some of which may be serious or unexpected. The study team will explain all known and potential risks in detail, and your health will be closely monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
France
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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 the bone marrow.

What does 'relapsed and refractory' mean?

It means the cancer has come back after treatment (relapsed) and has not responded well to previous treatments (refractory).

What is idecabtagene vicleucel?

It's a new type of treatment being investigated for multiple myeloma. It's sometimes called a 'cell therapy' or 'BB2121'.

Will I know if I'm getting the treatment?

Yes, this is an 'open-label' study, which means both you and your doctors will know you are receiving idecabtagene vicleucel.

What is a Phase 2 study?

Phase 2 studies are done after a treatment has been shown to be safe in a small group of people (Phase 1). They involve more people and aim to see how well the treatment works and further assess its safety.