A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
This important study is investigating a new medication called linvoseltamab for people with multiple myeloma that has come back or needs further treatment after initial therapies. We know that linvoseltamab has shown promising results in earlier studies for very advanced cases. This current research aims to compare it directly with a common combination of existing drugs – elotuzumab, pomalidomide, and dexamethasone – to see how safe and effective linvoseltamab is for patients who still have standard treatment options available. Half of the participants will receive linvoseltamab, and the other half will get the combination therapy, allowing researchers to understand which approach offers better outcomes, fewer side effects, and improved quality of life.
At a glance
What is this study about?
This study is looking at an experimental drug called linvoseltamab (also known as REGN5458) for treating multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells in your bone marrow. Sometimes, after treatment, the myeloma can return or stop responding to initial therapies; this is called 'relapsed/refractory' multiple myeloma.
Previously, linvoseltamab was tested in people with very advanced multiple myeloma where many other treatments had stopped working and there weren't many good options left. In those early studies, some patients saw their myeloma improve, and in some cases, all signs of the cancer disappeared. This current study is a step forward, comparing linvoseltamab in people whose myeloma has returned after one to four previous treatments with a standard treatment option. The standard treatment in this study is a combination of three drugs: elotuzumab, pomalidomide, and dexamethasone, often called EPd.
The main goal is to find out if linvoseltamab is a better, safer, or equally good option for these patients. Researchers will be carefully observing how long people benefit from each treatment, how much the myeloma improves, any side effects that occur, and overall quality of life, including whether pain is reduced. By comparing these two approaches, the study hopes to offer clearer information about future treatment choices for people with multiple myeloma.
Key takeaways
- This study is for adults with multiple myeloma that has returned or needs new treatment.
- It compares a new experimental drug (linvoseltamab) to a standard three-drug therapy (EPd).
- Participation involves random assignment to one of the treatments.
- Researchers will monitor how well the treatments work and any side effects.
- The aim is to find better treatment options for multiple myeloma.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. You should have been diagnosed with multiple myeloma that has come back or worsened after receiving at least one, but no more than four, previous treatments. These past treatments must have included specific drugs like lenalidomide and a proteasome inhibitor.
In some cases, if you live in the UK or EU, you would also need to have received a CD38 antibody as part of your past treatments. The medical team will check details about your specific myeloma, including whether it can be measured for response, and confirm that your general health, blood counts, and organ functions (like liver, kidney, and heart) are suitable for the study.
However, you would not be able to join if you have certain other conditions, such as plasma cell leukemia or a history of a bone marrow transplant within specific timeframes. Also, if you’ve recently had other cancer treatments or if you already received elotuzumab or pomalidomide, you might not be eligible. The study team will discuss all these points with you to see if the study is a good fit.
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?
- Has your multiple myeloma returned or needs treatment after 1 to 4 previous therapies?
- Did your previous treatments include lenalidomide and a 'proteasome inhibitor'?
- Do you have suitable blood counts and organ function for treatment?
- Have you NOT previously received elotuzumab or pomalidomide?
- Have you been free from a stem cell transplant for at least 3 months (or 6 months for certain transplants)?
What does participation involve?
If you join this study, you will be randomly assigned to receive either the experimental drug linvoseltamab or the standard combination of elotuzumab, pomalidomide, and dexamethasone (EPd). This means you won’t choose which treatment you get. Your treatment will involve regular clinic visits for medication administration, blood tests, and other assessments to monitor your health and how your body is responding to the treatment. The researchers will also be checking for any side effects you might experience. There will be ongoing follow-up to track your health and the progress of your multiple myeloma while you are on the study treatment and even after you stop treatment. The total length of the study's active treatment phase will vary depending on your individual response, but follow-up can continue for an extended period.
Potential risks and benefits
Locations (159)
- University of California Los Angeles (UCLA)Verified postcodeLos Angeles, United States· Active not recruiting
- University of Florida Division of Sponsored ProgramsVerified postcodeGainesville, United States· Withdrawn
- University of Kentucky, Markey Cancer Center Clinical Research OrganizationVerified postcodeLexington, United States· Active not recruiting
- Norton Cancer InstituteVerified postcodeLouisville, United States· Active not recruiting
- Stony Brook UniversityVerified postcodeStony Brook, United States· Active not recruiting
- Levine Cancer CenterVerified postcodeCharlotte, United States· Active not recruiting
- Duke University Medical CenterVerified postcodeDurham, United States· Withdrawn
- Kaiser Permanente NorthwestVerified postcodePortland, United States· Active not recruiting
- MD Anderson Cancer CenterVerified postcodeHouston, United States· Active not recruiting
- University of WashingtonVerified postcodeSeattle, United States· Active not recruiting
- Royal Prince Alfred HospitalVerified postcodeCamperdown, Australia· Active not recruiting
- Royal North Shore HospitalVerified postcodeSt Leonards, Australia· Active not recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow.
What does 'relapsed/refractory' mean?
It means the multiple myeloma has returned after previous treatments or has stopped responding to those treatments, needing a change in approach.
What is the difference between linvoseltamab and EPd?
Linvoseltamab is an experimental new drug being tested, while EPd (elotuzumab, pomalidomide, and dexamethasone) is a combination of three established cancer drugs used in treatment.
Will I know which treatment I'm getting?
No, you will be randomly assigned to receive either linvoseltamab or the EPd combination, meaning you will not choose which one you get.
What if I experience side effects?
The study team will closely monitor you for any side effects and will provide care and guidance. You should report any new or worsening symptoms immediately.
How to find out more
Clinical Trials Administrator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.