Comparison of Elranatamab and Lenalidomide Versus Daratumumab and Lenalidomide as Post-transplant Maintenance Therapy in Patients With Newly Diagnosed Myeloma (ElMMA)
This study, called ELMMA, is looking at two different medicine combinations for people with a type of blood cancer called multiple myeloma. These medicines are given after a stem cell transplant, which is a common treatment for this cancer. One combination is Elranatamab with Lenalidomide, and the other is Daratumumab with Lenalidomide. Both medicines are already used for multiple myeloma in various situations. The main goal is to see which combination is better at keeping the cancer under control by checking for very small amounts of cancer cells in the body after one year. The study will also look at how long people stay healthy, their quality of life, and if the treatments have any side effects. It’s for adults who have recently been diagnosed with multiple myeloma and have had a stem cell transplant.
At a glance
What is this study about?
If you've recently been diagnosed with multiple myeloma and have had a stem cell transplant, doctors often recommend ongoing medication to help keep the cancer from coming back. This is called 'maintenance therapy'. Currently, a drug called lenalidomide is a standard treatment for this, and evidence suggests that adding another drug called daratumumab can make it even more effective in preventing the cancer from returning for longer.
Researchers are now exploring a newer type of drug called elranatamab, which has shown promising results in people whose multiple myeloma has returned or not responded to other treatments. This study wants to compare elranatamab, when given with lenalidomide, against the current standard of daratumumab with lenalidomide after a stem cell transplant. The aim is to find out if this newer combination works even better to prevent the cancer from returning and if it's safe.
The main thing doctors want to find out is how well each treatment reduces the amount of cancer cells in the body after one year. They'll also be looking at how long people stay free from their cancer progressing, their overall health and well-being, and how the treatments might affect their daily lives, including getting back to work. This study is important because it could lead to better long-term treatment options for people with multiple myeloma.
Key takeaways
- This study compares two treatments for recently diagnosed multiple myeloma after a stem cell transplant.
- It aims to find out if a newer drug (Elranatamab) combined with Lenalidomide works better than an existing combination (Daratumumab with Lenalidomide).
- The main goal is to reduce tiny amounts of cancer cells in the body.
- It will also look at how treatments affect your health, quality of life, and safety.
- Participation involves taking medication for two years and regular hospital visits.
Who may be eligible?
To be considered for this study, you need to be an adult (18 years or older) who has been recently diagnosed with multiple myeloma. Crucially, you must have already gone through a specific course of initial treatments, including a 'quadruplet-based therapy' (meaning four different drugs) and then had a high-dose chemotherapy followed by an autologous stem cell transplant. Your transplant should have happened within the last six months.
Another important point is that your cancer must have responded well to the initial treatments, meaning it's either fully or partially under control. Doctors will also check your general health, including your blood test results, kidney function, and liver function, to make sure you're well enough to take part and that the treatments would be safe for you. You should also be able to carry out most of your usual daily activities without too much difficulty.
Finally, you'll need to be willing to provide your written consent to join the study and understand that you can leave the study at any time without affecting your future medical care. Researchers will also need to be able to test for any remaining cancer cells in your body using samples taken at diagnosis.
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 had initial treatment and an autologous stem cell transplant within the last six months?
- Has your myeloma responded well to initial treatments?
- Are you generally able to do most of your daily activities?
What does participation involve?
If you decide to participate in this study, you would be randomly assigned to receive one of two treatment combinations: either Elranatamab plus Lenalidomide, or Daratumumab plus Lenalidomide. Both treatments will be given for two years. This will involve regular visits to the hospital for your medication and various check-ups. During these visits, doctors will perform physical examinations, take blood samples, and ask you questions about how you are feeling and any side effects you might be experiencing. They will also look at your quality of life. After the two years of treatment, there will be follow-up appointments to monitor your health and the status of your multiple myeloma.
Potential risks and benefits
Locations (36)
- CHU AngersVerified postcodeAngers, France
- CH Côte BasqueVerified postcodeBayonne, France
- CHU BesançonVerified postcodeBesançon, France
- CHU CaenVerified postcodeCaen, France
- Hôpital d'Instruction des Armées PercyVerified postcodeClamart, France
- CHU Clermont- Ferrand - Hôpital ESTAINGVerified postcodeClermont-Ferrand, France
- Hôpital Henri MondorVerified postcodeCréteil, France
- CHRU DijonVerified postcodeDijon, France
- Institut de cancérologie de BourgogneVerified postcodeDijon, France
- Hôpital Annecy GenevoisVerified postcodeÉpagny, France
- CHD VendéeVerified postcodeLa Roche-sur-Yon, France
- CH Le Mans - Centre de cancérologie de la SartheVerified postcodeLe Mans, France
Common questions
What is 'maintenance therapy'?
Maintenance therapy is ongoing treatment given after initial intensive treatment to help keep a cancer like multiple myeloma from coming back or progressing.
What is a 'stem cell transplant'?
A stem cell transplant (specifically, an 'autologous' one in this context) replaces unhealthy blood-forming cells with healthy ones taken from your own body beforehand.
What is 'minimal residual disease (MRD)'?
MRD refers to tiny amounts of cancer cells that remain in the body after treatment, too few to show up on standard tests but detectable with very sensitive methods.
Are the study drugs new?
Lenalidomide and Daratumumab are established treatments for multiple myeloma. Elranatamab is newer and currently approved for relapsed myeloma, with ongoing research for earlier use.
Will I know which treatment I'm getting?
Because this is a 'randomized' study, you will be assigned by chance to one of the two treatment groups. Sometimes studies are 'blinded' meaning you might not know which specific treatment you are receiving.
How to find out more
Cyrille TOUZEAU
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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