Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
This research trial is investigating whether a new medication called isatuximab, when added to two existing treatments (lenalidomide and dexamethasone), can help people with high-risk smoldering multiple myeloma. Smoldering multiple myeloma is a condition where abnormal cells are present, but it hasn't yet caused serious symptoms of multiple myeloma. The 'high-risk' part means there's a higher chance it could develop into full multiple myeloma. The main goal is to find out if the new combination can delay the disease from getting worse. Researchers will also look at how safe the new combination is, how well it works, and how long its effects last, compared to taking only lenalidomide and dexamethasone.
At a glance
What is this study about?
This study is about a condition called 'smoldering multiple myeloma,' which is a stage where abnormal white blood cells, called plasma cells, build up in your bone marrow. These cells can cause problems, but in smoldering multiple myeloma, they haven't yet caused serious symptoms like kidney problems, high calcium levels, anaemia, or bone damage. However, 'high-risk' smoldering multiple myeloma means there's a greater chance your condition could develop into full multiple myeloma.
The main purpose of this study is to test a new combination of medicines. The new drug called isatuximab will be given alongside two existing treatments, lenalidomide and dexamethasone. These are already used for multiple myeloma. The researchers want to see if adding isatuximab can stop or at least slow down the smoldering multiple myeloma from turning into active multiple myeloma, compared to just using lenalidomide and dexamethasone by themselves.
Throughout the study, the research team will carefully monitor participants to see how safe the new combination is and how well it's tolerated. They will also measure how effective the treatment is at controlling the disease, how long any beneficial effects last, and the overall quality of life for those taking part. This research is important because it could potentially offer a new way to help people with high-risk smoldering multiple myeloma, aiming to keep them healthier for longer.
Key takeaways
- This study evaluates a new combination treatment for high-risk smoldering multiple myeloma.
- The new therapy includes isatuximab plus lenalidomide and dexamethasone.
- The primary aim is to delay the progression of the disease to active multiple myeloma.
- The study involves a treatment period of up to 3 years and a long-term follow-up.
- Careful monitoring for safety and effectiveness will occur throughout.
- Participation requires meeting specific health and disease criteria.
Who may be eligible?
To be able to join this study, doctors will first check if you meet certain requirements. You must have been diagnosed with high-risk smoldering multiple myeloma within the last five years. Importantly, you shouldn't have any of the serious symptoms usually linked with active multiple myeloma, such as kidney damage, very high calcium levels, severe anaemia (low red blood cells), or bone lesions.
There are also some general health requirements. For example, your blood counts, like your white blood cells and platelets, need to be at a certain level. Your liver and kidney function, as shown by specific blood tests, also need to be within a healthy range. You'll also need to be able to move around and do daily activities mostly on your own, with little to no difficulty.
If you have certain other conditions, you might not be able to participate. This includes if you have active multiple myeloma, another type of blood condition called MGUS, or certain infections. The medical team will review all your detailed health information to determine if this study is suitable for you.
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 'high-risk smoldering multiple myeloma' within the last 5 years.
- I do NOT have active multiple myeloma symptoms like bone damage, kidney problems, or severe anaemia.
- My blood tests (like white blood cells, platelets, liver, and kidney function) are generally healthy.
- I am able to carry out my daily activities mostly independently (ECOG Performance Status 0-2).
- I am at least 18 years old.
What does participation involve?
If you decide to take part in this study, it's expected to involve a number of steps over a long period. First, there's a screening period of about 42 days where doctors will perform tests to confirm you're suitable. After that, you would receive treatment for up to 3 years (36 months). During this treatment phase, you would take the study medications and have regular check-ups, blood tests, and scans to see how you're responding and to monitor for any side effects.
Following the treatment period, there will be a follow-up phase which could last for around 9 years. During this time, you would have occasional visits or contact with the study team to check on your long-term health. The total duration of your involvement in the study, from screening to the end of follow-up, could be up to 12 years. You might also receive other supportive medications during the study, like montelukast, acetaminophen, diphenhydramine, or methylprednisolone, to help manage potential side effects of the main treatments.
Potential risks and benefits
Locations (105)
- UCLA Site Number : 8400010Verified postcodeLos Angeles, United States
- Colorado Blood Cancer Institute Site Number : 8400007Verified postcodeDenver, United States
- Cancer Specialist of North Florida Site Number : 8400011Verified postcodeJacksonville, United States
- University of Miami Site Number : 8400012Verified postcodeMiami, United States
- Dana Farber Cancer Institute Site Number : 8400001Verified postcodeBoston, United States
- Presbyterian Hospital Site Number : 8400015Verified postcodeCharlotte, United States
- Novant Health Forsyth Medical Center Site Number : 8401015Verified postcodeWinston-Salem, United States
- Tennessee Oncology Site Number : 8400006Verified postcodeNashville, United States
- ~University of Texas - MD Anderson Cancer Center Site Number : 8400002Verified postcodeHouston, United States
- Investigational Site Number :0360008Verified postcodeLiverpool, Australia
- Investigational Site Number :0360005Verified postcodeWaratah, Australia
- Investigational Site Number :0360001Verified postcodeWollongong, Australia
Common questions
What is 'smoldering multiple myeloma'?
It's a condition where you have abnormal plasma cells in your bone marrow, but you don't yet have the symptoms of active multiple myeloma like bone problems or kidney damage. 'High-risk' means it's more likely to progress.
What are the treatments being tested?
The study is looking at a new drug, isatuximab, in combination with two existing treatments, lenalidomide and dexamethasone, compared to just lenalidomide and dexamethasone alone.
How long will the study last if I join?
The total study could last up to 12 years, including a screening period, up to 3 years of treatment, and about 9 years of follow-up.
What are the main goals of the study?
The main goal is to see if the new drug combination can delay the disease from getting worse (progressing) compared to standard treatment alone. Researchers will also look at safety.
Will I know which treatment I'm getting?
This is a 'randomized' study, meaning a computer will decide which treatment group you are in, and you might not know which specific treatment you are receiving until the study is over. This helps keep the study fair.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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