A Study of Daratumumab
This study is designed for people with multiple myeloma or smouldering multiple myeloma who have previously taken part in other Janssen research studies involving a medication called daratumumab. Its main goal is to allow these patients to continue receiving the beneficial treatments. This ensures that those who are doing well on daratumumab (either alone or with other drugs like carfilzomib, dexamethasone, lenalidomide, or pomalidomide) can keep getting them. The study will also continue to collect important information about the long-term safety of these treatments. This helps researchers understand the full picture of how these medicines affect people over time.
At a glance
What is this study about?
This study is about a type of blood cancer called multiple myeloma, and also a related condition called smouldering multiple myeloma. If you're reading this, you might have one of these conditions or know someone who does. This particular study isn't about testing a new drug from scratch. Instead, it's designed for people who have already taken part in other clinical trials run by a company called Janssen. Specifically, it's for those who were taking a medication called daratumumab during those earlier trials and found it helpful.
The main aim of this study is to make sure that people who are benefiting from daratumumab (either by itself or combined with other treatments like carfilzomib, dexamethasone, lenalidomide, or pomalidomide) can keep receiving it. This is really important because sometimes when a trial finishes, patients might no longer have access to a treatment that was working well for them. This study aims to bridge that gap.
Another important aspect of this study is to continue gathering information about the long-term safety of daratumumab. By observing patients who continue to receive the treatment, researchers can build a more complete picture of any potential side effects or health changes that might occur over a longer period. This helps everyone understand the treatment better and use it more safely and effectively in the future.
Key takeaways
- This study offers continued treatment access for previous trial participants.
- It's for people with multiple myeloma or smouldering multiple myeloma.
- The main drug involved is daratumumab, often with other medications.
- It aims to allow continued benefit from treatment and collect long-term safety data.
- Participation requires you to have already benefited from daratumumab in a prior Janssen study.
- Your doctor must also agree that continued treatment is in your best interest.
Who may be eligible?
To be considered for this study, you must have previously participated in specific Janssen research studies for multiple myeloma or smouldering multiple myeloma. During that earlier study, you must have been actively receiving daratumumab (either alone or with other treatments) or another treatment within a daratumumab study, and it must have been working well for you without your condition getting worse.
You also need to have received your last dose of the study treatment within the last three months, and your doctor must believe that continuing the treatment will be more helpful than harmful for you. There are also standard requirements such as women of childbearing potential needing negative pregnancy tests and agreeing to further tests during the study, and men agreeing not to donate sperm for a period.
You cannot join if you've taken any disallowed medicines between your previous study finishing and the start of this one. Also, if your doctor thinks that taking part would not be in your best interest or could complicate the study, you would not be able to participate. Finally, if you're allergic or sensitive to any of the study medications, you wouldn't be able to join.
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.
- Have I taken part in a Janssen study for multiple myeloma or smouldering multiple myeloma before?
- Did I receive daratumumab (or another study treatment in a daratumumab study) in that previous trial, and was it working for me?
- Was my last dose of study treatment within the last 3 months?
- Am I willing to have regular check-ups and follow the study instructions?
- Do I have any allergies to the study medications?
What does participation involve?
If you are eligible and agree to take part, you will continue to receive the study treatment (which includes daratumumab, possibly with other medications like carfilzomib, dexamethasone, lenalidomide, or pomalidomide) that you were receiving in your previous Janssen study. The specific schedule for your medication and any clinic visits or tests will be explained to you in detail by the study team.
Throughout the study, the team will continue to monitor your health closely. This will involve regular check-ups, blood tests, and other assessments to ensure the treatment is still working for you and to check for any side effects. The study will also collect information about your long-term safety. You will need to adhere to specific lifestyle advice during the study. The total duration of your participation will depend on how long you continue to benefit from the treatment and remain part of the study.
Potential risks and benefits
Locations (91)
- University of Miami Sylvester Cancer CenterVerified postcodeMiami, United States· Active not recruiting
- Emory UniversityVerified postcodeAtlanta, United States· Active not recruiting
- University of Michigan Comprehensive Cancer CenterVerified postcodeAnn Arbor, United States· Active not recruiting
- Barnes-jewish HospitalVerified postcodeSt Louis, United States· Active not recruiting
- Icahn School of Medicine at Mount Sinai - The Derald H. RuttenbergVerified postcodeNew York, United States· Completed
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Completed
- Baylor University Medical CenterVerified postcodeDallas, United States· Completed
- ZAS CadixVerified postcodeAntwerp, Belgium· Active not recruiting
- UNICAMPVerified postcodeCampinas, Brazil· Active not recruiting
- Liga Norte Riograndense Contra O CancerVerified postcodeNatal, Brazil· Active not recruiting
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRSVerified postcodePorto Alegre, Brazil· Active not recruiting
- Ministerio da Saude Instituto Nacional do CancerVerified postcodeRio de Janeiro, Brazil· Active not recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in your bone marrow.
What is smouldering multiple myeloma?
Smouldering multiple myeloma is an early, slow-growing stage of multiple myeloma that doesn't usually cause symptoms, but can turn into active myeloma.
What is daratumumab?
Daratumumab is a type of targeted drug treatment, often called a monoclonal antibody, used to treat multiple myeloma.
Will I have to pay for the treatment?
Clinical trials typically provide study-related medications and care free of charge to participants, but you should confirm this with the study team.
What does a 'Phase 3' study mean?
A Phase 3 study usually means the treatment has already been shown to be effective in smaller studies, and now it's being compared to existing treatments or further evaluated in a larger group of people to confirm its benefits and monitor side effects.
How to find out more
Study Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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