RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events

This research study aims to find the best ways to stop or lessen taste changes (like food tasting different or having no taste) that can happen when taking certain cancer medicines, such as talquetamab and ramantamig, for multiple myeloma. The study will look at different treatments given before or at the same time as the cancer medicine to see if they can help. By doing this, we hope to make these important cancer treatments more comfortable for people. The study also wants to understand more about these taste changes and how they affect patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

210

Start

26 Aug 2024

Estimated completion

30 May 2030

Multiple Myeloma

What is this study about?

Imagine finding that your favorite foods suddenly taste different or not at all. This can be a side effect for some people taking new medicines for multiple myeloma, a type of blood cancer. This study is exploring ways to prevent or reduce these taste changes, which doctors call 'dysgeusia'.

The medicines being looked at are called talquetamab and ramantamig. While these medicines are important for treating multiple myeloma, taste changes can make daily life difficult. This study will test different preventative treatments, like 'Prophylaxis A', 'Prophylaxis B', 'Prophylaxis C', and 'Prophylaxis D', to see if they can help stop these taste issues before they start, or make them less severe and shorter when they do happen.

By carefully studying how these preventative treatments work and by understanding more about exactly what these taste changes feel like for patients, the researchers hope to find better ways to support people undergoing treatment for multiple myeloma. The goal is to make sure patients can continue their important cancer treatment with fewer uncomfortable side effects, improving their overall quality of life.

Key takeaways

This study explores ways to prevent taste changes from multiple myeloma medicines.
It aims to make cancer treatment more comfortable for patients.
Different preventative treatments will be tested.
Participation involves taking new treatments and regular health checks.
It focuses on medicines called talquetamab and ramantamig for multiple myeloma.

Who may be eligible?

To join this study, you must have multiple myeloma that has been treated with certain types of medicines before (a PI, an IMiD, and an anti CD38 mAb). Your cancer needs to have shown signs of getting worse after your last treatment.

Your general physical health, as assessed by a doctor, should be good – meaning you can carry out most everyday activities without much trouble. If you normally use a wheelchair due to an older injury, you might still be able to join, as long as it's not because of your multiple myeloma or its treatment.

There are also some reasons why you might not be able to join. For example, if you've had a stroke or heart problems recently, or if you've had major surgery very recently. You also can't have serious taste changes already when the study starts.

Quick self-check

Do I have multiple myeloma?
Have I been treated with specific types of multiple myeloma drugs before?
Has my cancer shown signs of progressing after my last treatment?
Can I mostly carry out my normal daily activities?
Have I had any recent strokes, heart problems, or major surgery?
Do I already have severe taste problems?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The detailed information on what taking part involves is not provided in the brief summary. However, in a typical clinical study like this, you would likely have regular visits to a clinic or hospital for check-ups and to receive the study medications. This would include taking the preventative treatment along with your cancer medicine, talquetamab or ramantamig. You would have taste tests and be asked about any taste changes you notice. Doctors and nurses would also monitor your general health and any side effects. The study would likely last for some time, with follow-up appointments even after you’ve stopped the main treatments.

Potential risks and benefits

Taking part in this study could potentially help reduce or prevent unpleasant taste changes while you are being treated for multiple myeloma, making your cancer journey more comfortable. However, as with any medical study, there's always a chance that the preventative treatments might not work for you, or they could have their own side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (38)

University of California San Francisco
San Francisco, United States· Recruiting
Colorado Blood Cancer Institute
Denver, United States· Recruiting
Yale University School Of Medicine
New Haven, United States· Recruiting
Icahn School of Medicine at Mt. Sinai
New York, United States· Recruiting
University of Rochester Medical Center
Rochester, United States· Recruiting
Duke University Medical Center
Durham, United States· Recruiting
University Hospitals Cleveland Medical Center
Cleveland, United States· Recruiting
Virginia Commonwealth University - Massey Cancer Center
Richmond, United States· Recruiting
University of Washington
Seattle, United States· Recruiting
Hospitais Integrados da Gavea SA DF Star
Brasília, Brazil· Recruiting
Fundacao Universidade de Caxias do Sul
Caxias do Sul, Brazil· Recruiting
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Curitiba, Brazil· Recruiting

+26 more sites — see the official record for the full list.

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects certain cells in your bone marrow.

What are 'taste changes' or 'dysgeusia'?

Taste changes mean that food might taste different than usual, or you might have a strange taste in your mouth, or not be able to taste at all.

Are the medicines talquetamab and ramantamig new?

These are specific medicines used to treat multiple myeloma, and this study aims to make them more manageable by preventing a common side effect.

What does 'prophylaxis' mean?

Prophylaxis means taking measures to prevent something from happening. In this study, it's about trying to prevent taste changes.

What is a 'Phase 2' study?

A Phase 2 study is a stage of clinical research where doctors look into how safe a new treatment is and if it works well for a specific condition.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.