Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

This research study is looking into a new treatment called bb2121 for people with multiple myeloma, a type of blood cancer, where their condition has either returned or isn't getting better with previous standard treatments. It's a large study, involving around 381 participants. Patients will be randomly assigned to receive either the new treatment (bb2121) or one of the usual combinations of medicines. The main goal is to find out if bb2121 is more effective and safer than currently available treatments. This is important for patients who have limited options after multiple rounds of therapy. The study aims to provide valuable information to help improve future care for people with this challenging condition.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Celgene

Enrolment target

381

Start

16 Apr 2019

Estimated completion

08 Apr 2027

Multiple Myeloma

What is this study about?

This study is for people who have multiple myeloma, a type of cancer that affects the plasma cells in your bone marrow. These cells are part of your immune system. The study focuses on people whose multiple myeloma has already been treated at least twice but has either come back or isn't responding to those treatments anymore. This is often called 'relapsed and refractory' multiple myeloma.

The main aim of this study is to compare a new experimental treatment, called bb2121, with some of the standard treatments currently used for this type of multiple myeloma. The researchers want to see if bb2121 works better at controlling the cancer and if it's safe to use. You might receive bb2121 or one of the standard drug combinations, including medicines like Daratumumab, Pomalidomide, Dexamethasone, or others. This is a Phase 3 study, which means it’s one of the final stages of testing before a new treatment can potentially be made widely available.

Finding new and effective treatments is really important for people living with multiple myeloma, especially when their condition has become harder to treat. This study hopes to provide important information that could lead to new and better options for patients in the future.

Key takeaways

Tests a new treatment (bb2121) for multiple myeloma that has come back or isn't responding.
Compares bb2121 to standard treatments currently used.
For adults aged 18 and over with specific prior treatment history.
Involves random assignment to either the new treatment or standard care.
Requires long-term follow-up for those receiving the new treatment.
Aims to find better options for challenging multiple myeloma cases.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a clear diagnosis of multiple myeloma that can be measured. Your cancer must have returned or not responded after at least two, but no more than four, previous treatments. These past treatments must have included specific medicines like Daratumumab, a proteasome inhibitor, and an immunomodulatory drug.

Also, your multiple myeloma must have shown signs of getting worse during, or soon after, your very last treatment. You should have shown some improvement to at least one of your previous treatments. Your general health and ability to perform daily activities should be good, falling into a category of '0' or '1' on a simple health scale. Most side effects from previous treatments (except for hair loss or mild nerve problems) need to have resolved or returned to normal.

For women who could become pregnant, there are specific requirements concerning birth control that you would need to discuss with the study team.

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 a confirmed diagnosis of multiple myeloma that can be measured?
Has your multiple myeloma come back or not responded after at least two, but no more than four, previous treatments?
Did your last treatment stop working, or did your condition get worse within 60 days of finishing it?
Is your general health good, allowing you to carry out daily activities easily (ECOG 0 or 1)?
Are most side effects from your previous treatments gone or back to normal (excluding mild hair loss or nerve issues)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups: one receiving the new treatment (bb2121) or one receiving standard treatments. This means neither you nor the doctors will choose which treatment you get. Before starting, you'll have various tests and check-ups to make sure you're suitable. If you move forward, you'll likely need to have a procedure called 'leukapheresis' to collect some of your blood cells.

The study involves regular visits for blood tests, examinations, and to receive your treatment. For those receiving bb2121, you'll need to agree to follow-up over a much longer period, possibly up to 15 years, to monitor the effects of this type of therapy. The total duration of active treatment and follow-up will depend on which group you are in and how your condition responds.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment (bb2121) that isn't widely available yet, which could potentially be more effective for your multiple myeloma. Alternatively, you would receive established standard treatments. However, like all medical treatments, there are potential risks and side effects involved with both the new and standard therapies, which will be fully explained by the study team. Your health will be closely monitored throughout the study. Remember, joining 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 (60)

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

Local Institution - 109
Verified postcode
Birmingham, United States
Local Institution - 141
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Scottsdale, United States
Local Institution - 145
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Los Angeles, United States
Local Institution - 122
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Los Angeles, United States
Local Institution - 124
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Palo Alto, United States
Local Institution - 142
Verified postcode
Aurora, United States
Local Institution - 108
Verified postcode
Jacksonville, United States
Local Institution - 102
Verified postcode
Tampa, United States
Local Institution - 131
Verified postcode
Atlanta, United States
Local Institution - 140
Verified postcode
Atlanta, United States
Local Institution - 139
Verified postcode
Chicago, United States
Local Institution - 100
Verified postcode
Indianapolis, United States

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in the plasma cells in your bone marrow. These cells are a key part of your immune system.

What does 'relapsed and refractory' mean?

It means your multiple myeloma has either returned after getting better with treatment (relapsed) or hasn't responded to previous treatments (refractory).

What is bb2121?

bb2121 is an experimental new treatment being tested for multiple myeloma in this study. It's not yet a standard approved treatment.

Will I definitely get the new treatment?

No, you will be randomly assigned to either receive bb2121 or one of the standard treatment combinations. It's like flipping a coin for which group you join.

How long will I be involved in the study?

The active treatment and follow-up period will vary. If you receive bb2121, you might be followed for up to 15 years to monitor the long-term effects.