A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
This research study is looking at a new medication called JNJ-79635322. It's for adults with either multiple myeloma (a type of blood cancer) that has come back or hasn't improved after other treatments, or AL amyloidosis (a rare condition where abnormal proteins build up in organs) that has been treated before. The main goals are to find the right dosage of the drug that is safe and tolerable, and to understand any side effects it might have. This is a Phase 1 study, which means it's one of the first times this drug is being tested in people. It will help doctors learn how the drug works and if it could be a helpful new treatment option in the future.
At a glance
What is this study about?
This study is investigating a new medication, JNJ-79635322, for two specific medical conditions: multiple myeloma and AL amyloidosis. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow and currently doesn't have a cure. AL amyloidosis is a rare disease where abnormal proteins, called amyloid, build up in different organs and can stop them from working properly. For both conditions, this study focuses on people whose illness has either returned after treatment or didn't respond well to previous treatments.
The main purpose of this study is to find the safest and most effective dose of JNJ-79635322. This is often called the 'recommended phase 2 dose' (RP2D). Researchers will start with a small group of participants and gradually increase the dose to see how the body reacts and to identify any side effects. Once a safe dose is found, more people will join the study to further understand the drug's safety and how well it is tolerated across different groups of patients.
By taking part in this study, you could help doctors learn more about JNJ-79635322. Understanding its safety and how people react to different doses is a crucial step in developing new treatments. This research aims to contribute to finding new and better ways to manage multiple myeloma and AL amyloidosis for patients in the future.
Key takeaways
- This study is testing a new drug, JNJ-79635322, for multiple myeloma and AL amyloidosis.
- It's for people whose conditions haven't responded well to other treatments.
- The main aim is to find a safe and tolerable dose of the drug.
- It's a Phase 1 study, focusing on early safety and how the drug acts in the body.
- Participation involves regular clinic visits for tests and monitoring.
- You have the right to stop participating at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old. If you have been diagnosed with multiple myeloma, your illness must have come back or not responded to previous treatments. Specifically, you would have already tried a few standard types of treatment, like a proteasome inhibitor, an IMiD agent, and an anti-CD38-based therapy.
For multiple myeloma, your overall health should be good enough for you to manage daily activities without too much difficulty. Doctors will also need to be able to measure your disease, for example, by looking at levels of certain proteins in your blood or urine. If you have AL amyloidosis, you would have already received treatment for it, and your medical team would consider you not suitable for other available treatments with proven benefits.
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?
- Do you have multiple myeloma that has returned or not improved with past treatments?
- Have you already tried certain standard multiple myeloma treatments (PI, IMiD, anti-CD38-based therapy)?
- Do you have AL amyloidosis and your doctor believes you're not a candidate for other established treatments?
- Are you generally able to carry out your daily activities without too much difficulty?
What does participation involve?
If you decide to take part in this study, you will receive the study medication, JNJ-79635322. The study is divided into two parts: an initial dose-finding part (Part 1) and a later part that expands on this to look at more people (Part 2). Regardless of which part you are in, you will have regular visits to the clinic. These visits will involve various assessments, such as blood tests, urine tests, physical examinations, and possibly scans, to check on your health, how the medication is affecting you, and how your condition is responding.
The frequency and duration of these visits will depend on the specific stage of the study and your individual response, but they will likely be quite regular, especially at the beginning. You will also have follow-up appointments after you stop taking the study medication. The total duration of your participation will vary depending on your medical situation and the study's design. The study team will provide you with a detailed schedule of visits and procedures if you are considered for participation.
Potential risks and benefits
Locations (29)
- City of HopeVerified postcodeDuarte, United States· Recruiting
- City of Hope Orange County Lennar Foundation Cancer CenterVerified postcodeIrvine, United States· Recruiting
- University of California San FranciscoVerified postcodeSan Francisco, United States· Recruiting
- Colorado Blood Cancer InstituteVerified postcodeDenver, United States· Recruiting
- Icahn School of Medicine at Mt. SinaiVerified postcodeNew York, United States· Recruiting
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Recruiting
- Levine Cancer InstituteVerified postcodeCharlotte, United States· Recruiting
- University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced MedicineVerified postcodePhiladelphia, United States· Recruiting
- MD Anderson Cancer CenterVerified postcodeHouston, United States· Recruiting
- UZ AntwerpenVerified postcodeEdegem, Belgium· Recruiting
- UZ GentVerified postcodeGhent, Belgium· Recruiting
- CHU de LiegeVerified postcodeLiège, Belgium· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in the bone marrow, affecting the plasma cells which are part of your immune system.
What is AL amyloidosis?
AL amyloidosis is a rare condition where abnormal proteins, called amyloid, build up in your organs and tissues, which can stop them from working properly.
What does 'relapsed or refractory' mean?
This means your condition has either come back after previous treatment, or it hasn't responded well to treatments you've tried before.
What is a 'Phase 1' study?
A Phase 1 study is one of the first times a new drug is tested in people. The main goal is to find a safe dose and see how the body handles the drug.
Will I know if I'm getting the active drug?
In this specific study, it's likely all participants will receive the active study drug, JNJ-79635322, as it's testing different doses.
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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