A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
Researchers are conducting a study to see if a medication called daratumumab, given as an injection under the skin, can help people with a condition called 'high-risk smoldering multiple myeloma' (SMM). SMM is a pre-cancerous condition that can sometimes develop into a more serious type of blood cancer called multiple myeloma. This study wants to find out if taking daratumumab early on can prevent or delay the SMM from getting worse, compared to just regular monitoring without active treatment. It's for adults aged 18 and over, and will involve close medical supervision to understand how well the treatment works and if it's safe.
At a glance
Results
Results from this study
Posted December 2025Results have been published for this study.
What is this study about?
You might be reading this because you or someone you know has been diagnosed with smoldering multiple myeloma (SMM). SMM is a condition where certain cells in your bone marrow, called plasma cells, are not normal, but you don't yet have all the signs or symptoms of full-blown multiple myeloma. However, in some people, SMM can eventually progress to multiple myeloma, which needs treatment.
This study is focused on a group of people with 'high-risk' SMM, meaning their condition is more likely to develop into multiple myeloma. The main goal is to see if a new medicine, called daratumumab (given as an injection under the skin), can help prevent or delay this progression. One group of participants will receive this medication, while another group will be closely monitored by their doctors without receiving the study drug, which is a standard approach for SMM. This comparison will help doctors understand if early treatment with daratumumab is beneficial.
The researchers want to find out if daratumumab can prolong the time people live without their SMM getting worse. They will be carefully tracking participants' health over time, looking for any signs of the disease progressing. This type of study is really important for finding new and better ways to manage conditions like SMM and potentially stop them from becoming more serious.
Key takeaways
- This study is for people with 'high-risk smoldering multiple myeloma'.
- It tests a new injectable drug, daratumumab, against regular monitoring.
- The main goal is to see if daratumumab can delay the disease from getting worse.
- Participation involves regular clinic visits and tests.
- You might receive the drug or be in the monitoring group (decided randomly).
- You can always leave the study at any time.
Who may be eligible?
This study is looking for adults aged 18 and older who have been diagnosed with 'high-risk smoldering multiple myeloma' within the last five years. To be considered high-risk, your doctors will have checked specific levels in your blood or urine, like certain proteins or cell counts, which indicate a higher chance of your condition progressing. You also need to be generally well and able to carry out your daily activities without much trouble.
There are also some specific medical requirements. For example, the levels of certain abnormal proteins in your blood or urine must be at a particular level, and the abnormal cells in your bone marrow must make up a certain percentage. Also, some of your normal immune system proteins might be at a lower level.
However, you cannot take part if you already have full multiple myeloma that needs treatment, especially if it has caused bone damage. Also, if you are a woman who could become pregnant, you would need to use effective birth control throughout the study and for some time afterwards, and you'd need a negative pregnancy test before starting.
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 been diagnosed with 'high-risk smoldering multiple myeloma' in the last 5 years?
- Do you feel well enough to carry out your normal daily activities?
- Do you understand that you cannot have bone damage or other signs of full multiple myeloma?
- If you are a woman of childbearing potential, are you able to use effective contraception?
- Do your doctors' recent test results (blood, urine, bone marrow) fit the 'high-risk' profile for this study?
What does participation involve?
If you join this study, you would first go through a screening process to make sure you're a good fit. If you qualify, you would then be randomly assigned to one of two groups: either receiving daratumumab injections or having active monitoring (regular check-ups without the study drug). The daratumumab injections are given under the skin.
Throughout the study, you would attend regular visits at the clinic. These visits would involve medical examinations, blood and urine tests, and possibly other scans or tests to monitor your health and how your condition is progressing. The frequency of these visits would vary, but they would be more frequent initially and then become less often over time. The total duration of your participation would depend on how your condition progresses and how long the study runs, but it could be several years. If you are in the treatment group, you would continue your injections for a set period unless your condition progresses or you experience side effects.
Potential risks and benefits
Locations (163)
- Arizona Oncology Associates, PC - HALVerified postcodePhoenix, United States
- Innovative Clinical Research IncVerified postcodeWhittier, United States
- Miami Cancer InstituteVerified postcodeMiami, United States
- Emory UniversityVerified postcodeAtlanta, United States
- University of Iowa Hospitals and ClinicsVerified postcodeIowa City, United States
- East Jefferson General HospitalVerified postcodeMetairie, United States
- Dana Farber Cancer InstituteVerified postcodeBoston, United States
- University of Michigan Comprehensive Cancer CenterVerified postcodeAnn Arbor, United States
- Mayo ClinicVerified postcodeRochester, United States
- Washington UniversityVerified postcodeSt Louis, United States
- VA Southern Nevada HealthcareVerified postcodeNorth Las Vegas, United States
- New York Oncology HematologyVerified postcodeAlbany, United States
Common questions
What is 'smoldering multiple myeloma'?
It's a condition where abnormal cells are found in your bone marrow, but you don't have symptoms or complications of full multiple myeloma yet. It's like a warning sign that needs careful watching.
What is daratumumab?
Daratumumab is a type of medicine that targets specific cells. In this study, it's being tested to see if it can help control the abnormal cells in smoldering multiple myeloma when given as an injection.
What does 'active monitoring' mean?
Active monitoring means your doctors will regularly check your health and your condition through tests and appointments, but you won't receive any specific medication for your smoldering multiple myeloma unless it gets worse.
Will I definitely get the new treatment?
Not necessarily. Yours will be one of two groups. One group will receive the new treatment, and the other will receive active monitoring. It's decided randomly, like flipping a coin.
How long would I be in the study?
The study could last for several years, with regular check-ups and follow-up. The exact duration would depend on your individual response and the study's overall plan.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.