A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma
This research study is looking into a new medicine called JNJ-87562761 for people with a type of blood cancer called multiple myeloma. This is for patients whose cancer has either returned after previous treatments (relapsed) or hasn't responded well to those treatments (refractory). The study has two main parts. First, researchers will carefully test different doses of the new medicine to find the safest and most effective amount. Once that dose is found, the second part of the study will involve more people taking that dose to get a clearer picture of how safe it is and what side effects might occur. The overall aim is to improve treatment options for multiple myeloma.
At a glance
What is this study about?
You've likely found this information because you or someone you know is living with multiple myeloma, a type of cancer that affects plasma cells in your bone marrow. Sometimes, despite receiving treatments, the cancer can return, or it might not respond as well as hoped to existing medications. When this happens, doctors call it 'relapsed' or 'refractory' multiple myeloma.
This particular study is focusing on a new medicine named JNJ-87562761. The main idea behind this research is to see if this new drug can be a helpful treatment option for people whose multiple myeloma has come back or hasn't improved with other treatments. It's an early-stage study, meaning it's one of the first times this medicine is being given to people, and the researchers are being very careful and thorough.
The study has two main steps. In the first step, a small group of participants will be given different amounts of JNJ-87562761 to find the best and safest dose. This is called 'dose escalation'. Once that best dose is identified, a larger group of people will receive it in the second step. This will help the doctors understand more about how safe the medicine is, what side effects it might cause, and how well people tolerate it. The ultimate goal is to find new and better ways to treat multiple myeloma.
Key takeaways
- This study is for people with multiple myeloma that has returned or not responded to previous treatments.
- It tests a new medicine called JNJ-87562761 to find a safe and effective dose.
- Your general health and previous treatments determine if you can join.
- Participation involves regular clinic visits for monitoring and receiving the study medicine.
- There are potential benefits and risks; discussion with your doctor is key.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you would need to meet certain health requirements. Your multiple myeloma must have come back after treatment or not have responded well to previous treatments. Your doctors would need to see clear signs of the cancer in your blood or urine tests. You must also have tried certain standard treatments already, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 therapy.
Your general health is also important. Doctors will check that you are reasonably active and capable of most daily activities. Your kidneys also need to be working well, which will be checked with a blood test. If you are a woman who could become pregnant, you must not be pregnant or breastfeeding and must use effective contraception during the study and for six months afterwards. Men in the study will also need to use contraception for six months after their last dose.
There are also some reasons why you might not be able to join. For example, if you have certain other specific blood conditions, or if your multiple myeloma has spread to your brain or spinal cord, you would not be eligible. If you've had a certain type of stem cell transplant within the last year, or have recently received a 'live' vaccine, you also couldn't take part. The study also cannot accept you if you have ongoing severe side effects from previous treatments that haven't gotten better.
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.
- Has my multiple myeloma come back or not responded to past treatments?
- Have I already tried a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 therapy?
- Am I generally active and able to perform most daily tasks?
- Do I have any other serious health conditions that might prevent me from joining?
- If I am a woman who could get pregnant, am I able to use effective contraception?
- If I am a man, am I able to use effective contraception?
What does participation involve?
If you decide to take part in this study, you would receive the new study medicine, JNJ-87562761. The exact details of how often you would receive the medicine and for how long would depend on which part of the study you are in and your individual treatment plan. You would have regular visits to the clinic for check-ups, blood tests, and other assessments to monitor your health and see how you are responding to the medicine. These visits would also be used to check for any side effects. You would be carefully followed up by the study team throughout your participation. The total duration of your involvement, including both treatment and follow-up, would be explained in detail by the study team.
Potential risks and benefits
Locations (15)
- Princess Margaret HospitalVerified postcodeToronto, Canada
- Jewish General HospitalVerified postcodeMontreal, Canada
- Seoul National University HospitalVerified postcodeSeoul, South Korea
- Asan Medical CenterVerified postcodeSeoul, South Korea
- Samsung Medical CenterVerified postcodeSeoul, South Korea
- The Catholic University of Korea Seoul St Marys HospitalVerified postcodeSeoul, South Korea
- Hosp. Univ. Germans Trias I PujolVerified postcodeBadalona, Spain
- Hosp Clinic de BarcelonaVerified postcodeBarcelona, Spain
- Hosp Univ Fund Jimenez DiazVerified postcodeMadrid, Spain
- Clinica Univ. de NavarraVerified postcodePamplona, Spain
- Hosp Clinico Univ de SalamancaVerified postcodeSalamanca, Spain
- Kaohsiung Chang Gung Memorial HospitalVerified postcodeKaohsiung City, Taiwan
Common questions
What is JNJ-87562761?
It's a new medicine being tested in this study for people with multiple myeloma that hasn't responded to other treatments or has come back.
What does 'relapsed or refractory' mean?
It means your multiple myeloma has either returned after you've had treatment, or it hasn't responded well to the treatments you've received.
Is this a new treatment?
Yes, this is an early-stage study (Phase 1), meaning it's one of the first times this particular medicine is being given to people to check its safety and find the right dose.
Will I definitely get the new medicine?
Yes, in this study, everyone who takes part will receive the new medicine, JNJ-87562761.
What if I decide I don't want to be in the study anymore?
You are free to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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