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RecruitingPHASE3INTERVENTIONAL

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

This research study is for people with multiple myeloma, a type of blood cancer, whose treatment hasn't worked or whose cancer has returned. The study aims to find out if new combinations of drugs are more effective than standard treatments. Specifically, it compares two new combinations, talquetamab plus pomalidomide, or talquetamab plus teclistamab, with existing treatments like elotuzumab, pomalidomide, and dexamethasone, or pomalidomide, bortezomib, and dexamethasone. Participants will have already received certain types of myeloma drugs before joining this trial. The goal is to discover better treatment options for people with this challenging form of myeloma.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Enrolment target
795
Start
22 Jan 2024
Estimated completion
31 Dec 2028

What is this study about?

This study is particularly for people who have multiple myeloma, a cancer that affects plasma cells in the bone marrow. It focuses on cases where the cancer has either not responded well to previous treatments (this is called 'refractory') or has returned after a period of improvement (this is called 'relapsed'). If you've been in this situation and have already received certain common myeloma drugs, this study might be relevant to you.

The main idea behind this research is to see if new combinations of medicines can work better than some of the current standard treatments. Specifically, the study is looking at a drug called talquetamab, which is being tested in combination with either pomalidomide or teclistamab. These new combinations are then compared against two established treatment combinations that include drugs like elotuzumab, pomalidomide, dexamethasone, and bortezomib.

By comparing these different drug combinations, researchers hope to identify more effective ways to treat multiple myeloma that is difficult to control. The aim is to improve outcomes for patients who have limited treatment options left.

Key takeaways

  • This study is for people with multiple myeloma that is difficult to treat.
  • It compares new drug combinations involving talquetamab with existing treatments.
  • You must have already received specific prior myeloma treatments to be eligible.
  • Participation involves regular hospital visits for treatments and monitoring.
  • The goal is to find more effective treatments for challenging myeloma cases.
  • You can discuss with your doctor if this study is suitable for you.

Who may be eligible?

To join this study, you must have multiple myeloma that has either come back or isn't responding to your current treatment. Your doctor needs to be able to measure your cancer, for example, through certain protein levels in your blood or urine. You must also have already received specific antibody treatments for your myeloma, including an anti-CD38 antibody and lenalidomide.

Your general health and ability to carry out daily activities will be checked, and you'll need to be in reasonably good health to participate. For example, your doctor will look at your overall fitness level using a common scale, aiming for a score of 0, 1, or 2, which means you're fairly active.

You cannot join if you have certain health conditions like a recent stroke or seizure within the last six months, or if you've had major surgery recently. Also, if you are pregnant, breastfeeding, or planning to become pregnant, you won't be able to take part in this study.

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. Do I have multiple myeloma that has come back or isn't responding to treatment?
  2. Has my doctor been able to measure my cancer markers?
  3. Have I already received an anti-CD38 antibody drug and lenalidomide?
  4. Am I generally active and able to perform daily tasks?
  5. Am I pregnant or breastfeeding, or planning to be?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to receive one of the treatment combinations being tested. This will involve regular visits to the hospital or clinic for blood tests, physical examinations, and to receive your study medication. The specific drugs and how they are given (e.g., orally or by injection) will depend on which treatment group you are in. Your health will be closely monitored throughout the study to track how the treatment is working and to watch for any side effects.

The total length of time you will be involved in the study can vary. You will receive treatment for as long as it is helping you and you are tolerating it well. After you stop taking the study medication, you will have follow-up appointments to continue monitoring your health and the long-term effects of the treatment. The number and frequency of visits will be explained in detail by the study team, but it will involve a commitment over an extended period.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. The potential benefit of joining this study is that you might receive a new treatment or combination of treatments that could be more effective for your myeloma than other available options, especially if your current treatments are not working. However, there is no guarantee that the treatment will help you. Like all medicines, the drugs used in this study can cause side effects. These could range from mild to serious, and the study team will monitor you closely for any issues and discuss them with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (242)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UCSF Fresno
    Verified postcode
    Clovis, United States· Active not recruiting
  • UCLA
    Verified postcode
    Santa Monica, United States· Active not recruiting
  • Yale University School Of Medicine
    Verified postcode
    New Haven, United States· Active not recruiting
  • Medical Oncology Hematology Consultants, PA
    Verified postcode
    Newark, United States· Recruiting
  • Memorial Healthcare System
    Verified postcode
    Hollywood, United States· Active not recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Active not recruiting
  • Winship Cancer Institute Emory University
    Verified postcode
    Atlanta, United States· Active not recruiting
  • City of Hope Cancer Center
    Verified postcode
    Newnan, United States· Recruiting
  • Kootenai Health
    Verified postcode
    Coeur d'Alene, United States· Completed
  • Loyola University Medical Center
    Verified postcode
    Maywood, United States· Active not recruiting
  • University of Iowa Health Care
    Verified postcode
    Waukee, United States· Active not recruiting
  • Norton Cancer Institute
    Verified postcode
    Louisville, United States· Active not recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in plasma cells, which are a type of white blood cell found in the bone marrow.

What does 'relapsed or refractory' mean?

Relapsed means the cancer has come back after treatment, and refractory means the cancer didn't respond or stopped responding to previous treatments.

Will I know which treatment I'm getting?

In some studies, you might not know which specific treatment combination you are receiving, but the study team will explain how treatments are assigned.

What is a 'Phase 3' study?

Phase 3 studies are large trials that compare a new treatment to existing standard treatments to see if it's better or has fewer side effects.

How long will I be in the study?

The length of time varies, but typically you remain on treatment as long as it's helping, followed by a period of monitoring and follow-up after the treatment stops.

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 Comparing Talquetamab Plus Pomalidomide, Talquetamab…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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