Active not recruitingPHASE3INTERVENTIONAL

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

This research study is looking at a new treatment called elranatamab for people who have recently been diagnosed with multiple myeloma and have already had a stem cell transplant. The study aims to find out if elranatamab is more effective than lenalidomide, a common treatment, at managing the cancer. Participants will receive either elranatamab as an injection under the skin or lenalidomide as a tablet taken daily at home. The study will involve regular check-ups and assessments over approximately five years. This is a "Phase 3" study, meaning it's one of the final steps to see if the new medicine is safe and works well enough to be widely used.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

854

Start

25 Mar 2022

Estimated completion

31 Oct 2029

Multiple Myeloma

What is this study about?

If you've recently been diagnosed with multiple myeloma and have had a stem cell transplant, you might be interested in this research study. It's designed to compare two different ways of treating your condition: a new medicine called elranatamab and a standard treatment, lenalidomide. Multiple myeloma is a type of cancer that affects plasma cells in your bone marrow.

After a stem cell transplant, the goal is often to keep the cancer from coming back or growing. This study wants to see if elranatamab is better than lenalidomide at doing this. Elranatamab works by helping your own immune system fight the cancer cells, while lenalidomide also helps control the cancer in other ways. Both treatments are given differently: elranatamab as an injection under the skin, and lenalidomide as a pill you take at home.

By taking part, you would be helping doctors understand which treatment works best for people like you. This sort of research is crucial for improving future care for multiple myeloma patients.

Key takeaways

Compares a new medicine (elranatamab) with a standard one (lenalidomide) for multiple myeloma.
For adults newly diagnosed with multiple myeloma who have had a stem cell transplant.
Participation lasts about five years with regular clinic visits.
Aim is to see which treatment best controls the cancer.
You won't choose your treatment; it's assigned randomly.
Helps improve future care for multiple myeloma patients.

Who may be eligible?

This study is looking for adults aged 18 or older who have been newly diagnosed with multiple myeloma. You must have already completed a stem cell transplant for your multiple myeloma. Your doctors will also need to confirm that your cancer responded to previous treatments, even if some cancer cells are still present.

There are also some medical conditions and treatments that would prevent you from joining. For example, if you have other types of plasma cell disorders or certain serious infections, you likely won't be able to take part. If you've had a specific type of treatment for your multiple myeloma before, or are pregnant, you also wouldn't be eligible.

The research team will carry out a thorough check to make sure the study is a safe and suitable option for you. They will ask about your overall health and medical history, and check some specific test results.

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 recently been diagnosed with multiple myeloma?
Have you already had a stem cell transplant for your multiple myeloma?
Are you generally well and able to manage daily activities?
Are you not pregnant and willing to use contraception if needed?
Have you *not* had certain other cancers or specific serious infections recently?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for about five years. You'll be assigned to one of two groups: one receiving elranatamab injections under the skin at the clinic, and the other taking lenalidomide pills by mouth at home every day. You won't get to choose which treatment you receive.

Throughout the five years, you'll have regular visits to the clinic for check-ups, blood tests, and other assessments to see how you're responding to the treatment and to monitor for any side effects. These visits will be more frequent at the beginning of the study and may become less so over time. The study team will provide all the necessary medication and guidance on how to take it or when to come for injections.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could be more effective than standard care, though this isn't guaranteed. You'll also receive close medical attention and monitoring throughout the study. However, there are potential risks, as both new and standard treatments can have side effects. The study team will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (209)

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

Banner Gateway Medical Center
Verified postcode
Gilbert, United States
Banner Gateway Medical Pavilion
Verified postcode
Gilbert, United States
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
Ronald Reagan UCLA Medical Center
Verified postcode
Los Angeles, United States
UCLA Department of Medicine - Hematology/Oncology
Verified postcode
Los Angeles, United States
UCLA Hematology/Oncology
Verified postcode
Los Angeles, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Verified postcode
Santa Monica, United States
UCLA Hematology/Oncology - Santa Monica
Verified postcode
Santa Monica, United States
Georgetown University Medical Center
Verified postcode
Washington D.C., United States
Miami Cancer Institute at Baptist Health, Inc.
Verified postcode
Miami, United States
Winship Cancer Institute, Emory University
Verified postcode
Atlanta, United States
Loyola University Chicago
Verified postcode
Maywood, United States

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects certain white blood cells in the bone marrow called plasma cells.

What is a stem cell transplant?

A stem cell transplant is a treatment that replaces damaged blood-forming cells with healthy new ones, often used after high-dose chemotherapy for multiple myeloma.

What does 'Phase 3' mean for a study?

Phase 3 means the study is in a later stage, comparing a new treatment to standard care to see if it's better and safe enough for wider use.

Will I know which treatment I'm getting?

In this study, you won't get to choose your treatment group. You'll either receive elranatamab or lenalidomide, as decided by the study design.

How long do I need to be involved in the study?

If you join, your participation in this study will last for around five years.

How to find out more

Official trial record

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