RecruitingPHASE3INTERVENTIONAL

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

This study is investigating new treatment options for people with multiple myeloma, a type of blood cancer, who have already received other treatments including lenalidomide. Researchers want to see if a new drug called elranatamab, either on its own or combined with another drug called daratumumab, works better and is safer than a common treatment combination (daratumumab, pomalidomide, and dexamethasone). The study will be in different parts: first, testing combined doses of elranatamab and daratumumab; then, comparing different treatment groups to see which is best; and finally, looking at ways to prevent infections. Participants will continue treatment until it stops working, side effects are too much, or they choose to stop.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

944

Start

04 Oct 2021

Estimated completion

31 May 2027

Multiple Myeloma

What is this study about?

This study is about finding better ways to treat multiple myeloma, which is a cancer that affects certain cells in your bone marrow. We know it can be a challenging condition, and sometimes treatments don't work as well as we'd hoped, or they stop working after a while. This is why researchers are always looking for new and more effective medicines.

In this particular study, they are focusing on people whose multiple myeloma has already been treated with other medicines, including one called lenalidomide. The main goal is to compare a new medicine called elranatamab, either by itself or with another drug called daratumumab, against a widely used treatment combination. By doing this, they hope to figure out if these new approaches can help people live longer, feel better, or have fewer side effects.

There are different parts to the study. Initially, they will check the safety and how well different doses of elranatamab work when given with daratumumab. Then, participants will be randomly assigned to receive one of the study treatments. The final part will look at extra ways to protect against infections, which can sometimes be a concern with these types of treatments. Everyone in the study will keep getting their assigned treatment for as long as it's helping and they're comfortable with it.

Key takeaways

This study evaluates new treatments for multiple myeloma.
It focuses on people who have already tried other therapies.
The main drug being tested is called elranatamab.
Different treatment combinations and extra infection protection are being explored.
Participants are closely monitored for safety and effectiveness.

Who may be eligible?

To join this study, people must have been diagnosed with multiple myeloma and have measurable signs of the disease. They also need to have tried other treatments for multiple myeloma before, including lenalidomide.

There are certain health conditions and situations that would prevent someone from joining. For example, if you have certain other types of multiple myeloma (like smoldering multiple myeloma or plasma cell leukemia), or if you've had a stem cell transplant recently, you wouldn't be able to take part. Also, if you have active infections like hepatitis, HIV, or recent COVID-19, or certain other cancers, you might not be eligible. If you've had a specific type of treatment for multiple myeloma before (BCMA-directed therapy), you also cannot join. Women must not be pregnant and agree to use contraception.

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.

I have been diagnosed with multiple myeloma.
My doctors can measure the signs of my multiple myeloma.
I have already received lenalidomide or similar treatments for my multiple myeloma.
I don't have other serious uncontrolled infections or cancers.
I haven't recently had a stem cell transplant or a special 'BCMA-directed' therapy.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through some checks to make sure the study is right for you. If you meet the criteria, you will be assigned to one of the treatment groups: either elranatamab alone, elranatamab with daratumumab, or a combination of daratumumab, pomalidomide, and dexamethasone. You'll receive these medications according to the study plan. The study team will regularly monitor your health through blood tests, scans, and other examinations to see how the treatment is working and to check for any side effects. You will continue to receive the study treatment for as long as your multiple myeloma is not getting worse, if the side effects are manageable, and if you wish to continue. The study will involve regular visits to the clinic for your treatments and check-ups. The exact number of visits and the total length of your participation will depend on how you respond to the treatment, but generally, treatment continues until it is no longer beneficial or you choose to stop.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new and promising treatments before they are widely available. There's a chance that elranatamab, alone or with daratumumab, could work better for you than standard treatments. However, like all medicines, there are potential risks and side effects, which the study team will explain in detail. These new drugs are still being investigated, so not all side effects are fully known. Your safety is a priority, and you'll be closely monitored throughout the study. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (90)

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

Clovis Community Medical Center
Verified postcode
Clovis, United States· Active not recruiting
Community Regional Medical Center
Verified postcode
Fresno, United States· Active not recruiting
UCHealth Poudre Valley Hospital
Verified postcode
Fort Collins, United States· Active not recruiting
UCHealth Greeley Hospital
Verified postcode
Greeley, United States· Active not recruiting
Sylvester Comprehensive Cancer Center - Aventura
Verified postcode
Aventura, United States· Recruiting
Sylvester Comprehensive Cancer Center - Coral Springs
Verified postcode
Coral Springs, United States· Recruiting
University of Miami Hospital and Clinics - Deerfield Beach
Verified postcode
Deerfield Beach, United States· Recruiting
Sylvester Comprehensive Cancer Center - Hollywood
Verified postcode
Hollywood, United States· Recruiting
University of Miami Hospital and Clinics
Verified postcode
Miami, United States· Recruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
Verified postcode
New York, United States· Recruiting
Memorial Sloan Kettering Cancer Center - Main Campus
Verified postcode
New York, United States· Recruiting
Hospital Universitario Austral
Verified postcode
Presidente Derqui, Argentina· Active not recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are white blood cells found in your bone marrow. These cells normally help fight infections. In multiple myeloma, abnormal plasma cells grow too much.

What does 'BCMA-CD3 bispecific antibody' mean?

This refers to the new drug elranatamab. It's a special type of medicine designed to attach to two different targets: BCMA on cancer cells and CD3 on immune cells, helping your own immune system fight the cancer.

Will I know which treatment I am getting?

In some parts of the study, you will be randomly assigned to a treatment group, and you might not know which one you are receiving, which is common in clinical trials to ensure fair comparison. The study team will explain this to you fully.

How long will the study last for me?

You will receive the study treatment for as long as it is working for your multiple myeloma, you are not experiencing severe side effects, or you choose to stop. The total duration can vary for each individual.

What if I experience side effects?

The study team will monitor you closely for any side effects. If you experience any, you should tell the study team immediately. They will provide care and may adjust your treatment if necessary.

How to find out more

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.