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RecruitingPHASE1INTERVENTIONAL

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

Status
Recruiting
Phase
PHASE1
Sponsor
Janssen Research & Development, LLC
Enrolment target
180
Start
22 Nov 2022
Estimated completion
28 Aug 2028

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.

  1. Are you 18 years old or older?
  2. Do you have multiple myeloma that has returned or not improved with past treatments?
  3. Have you already tried certain standard multiple myeloma treatments (PI, IMiD, anti-CD38-based therapy)?
  4. Do you have AL amyloidosis and your doctor believes you're not a candidate for other established treatments?
  5. Are you generally able to carry out your daily activities without too much difficulty?
Answer every question to see your result.

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

Taking part in any clinical trial has potential benefits and risks. You might not directly benefit from receiving JNJ-79635322, as it is a new drug and its full effects are not yet known. However, you would be helping researchers learn more about your condition and contribute to developing potential new treatments for others in the future. Potential risks include experiencing side effects from the study medication, which the doctors will monitor very closely. There might also be side effects from the tests and procedures involved in the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (29)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • City of Hope
    Verified postcode
    Duarte, United States· Recruiting
  • City of Hope Orange County Lennar Foundation Cancer Center
    Verified postcode
    Irvine, United States· Recruiting
  • University of California San Francisco
    Verified postcode
    San Francisco, United States· Recruiting
  • Colorado Blood Cancer Institute
    Verified postcode
    Denver, United States· Recruiting
  • Icahn School of Medicine at Mt. Sinai
    Verified postcode
    New York, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • Levine Cancer Institute
    Verified postcode
    Charlotte, United States· Recruiting
  • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
    Verified postcode
    Philadelphia, United States· Recruiting
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • UZ Antwerpen
    Verified postcode
    Edegem, Belgium· Recruiting
  • UZ Gent
    Verified postcode
    Ghent, Belgium· Recruiting
  • CHU de Liege
    Verified postcode
    Liège, 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?

Register your interest

Share your details and the research team for "A Study of JNJ-79635322 in Participants With Relapsed or Ref…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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