Active not recruitingPHASE3INTERVENTIONAL

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

This research study is investigating new treatment options for a type of blood cancer called multiple myeloma. This is for people whose cancer has returned after previous treatments or isn't responding well to them. The study aims to compare the effectiveness of different drug combinations. One combination involves a new drug called talquetamab, given with daratumumab and pomalidomide. Another uses talquetamab with just daratumumab. These are being compared against a common treatment that includes daratumumab, pomalidomide, and dexamethasone. Researchers want to see if the new combinations are better at controlling the cancer and improving patients' health.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

864

Start

13 Oct 2022

Estimated completion

25 May 2028

Relapsed or Refractory Multiple Myeloma

What is this study about?

This study is for people in the UK who have multiple myeloma, a type of blood cancer that affects plasma cells. Sometimes, after initial treatments, multiple myeloma can return or stop responding to the medicines. This is what doctors call 'relapsed or refractory' multiple myeloma.

The main goal of this particular study is to find out if new drug combinations could be more effective than current standard treatments for these patients. The study is comparing two new treatment approaches, both involving a drug called talquetamab, with a widely used combination of drugs: daratumumab, pomalidomide, and dexamethasone. By comparing these different combinations, researchers hope to identify better ways to manage the disease and improve outcomes for people living with multiple myeloma.

Understanding which treatments work best is crucial. This study is an important step in advancing our knowledge and potentially offering new hope for those whose multiple myeloma has become more challenging to treat. Your participation could help future patients facing similar conditions.

Key takeaways

This study evaluates new treatments for multiple myeloma that has returned or is resistant.
It compares combinations including a new drug, talquetamab, with standard therapy.
Participation involves receiving study drugs and regular health checks at the clinic.
The aim is to find more effective ways to manage advanced multiple myeloma.
Your doctor can help determine if this study is potentially suitable for you.

Who may be eligible?

To join this study, you must have a confirmed diagnosis of multiple myeloma that has either come back after treatment or isn't responding to your current treatments. Your doctor will need to see clear signs of the cancer in your blood or urine tests.

You should have already tried at least one other treatment for multiple myeloma. This must have included a type of drug called a proteasome inhibitor and another drug called lenalidomide. If you've only had one prior treatment, your cancer must have stopped responding to lenalidomide. If you've had two or more previous treatments, you just need to have been exposed to lenalidomide at some point.

Doctors will also check your general health and how well you can perform daily activities. You'll need to have a score of 0, 1, or 2 on a scale that measures this, which means you are reasonably active and able to look after yourself.

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.

Do you have a confirmed diagnosis of multiple myeloma?
Has your multiple myeloma come back or stopped responding to previous treatments?
Have you already had at least one prior myeloma treatment, including lenalidomide and a proteasome inhibitor?
Are you generally well and able to manage most 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 be assigned to one of the treatment groups. This will involve receiving specific medications: talquetamab, daratumumab, pomalidomide, and/or dexamethasone, depending on your group. These medications will primarily be given as injections under the skin (subcutaneous) or as tablets.

You will have regular visits to the clinic for medical check-ups, blood tests, urine tests, and to assess how you are feeling and responding to the treatment. These assessments are important to monitor your health and the effectiveness of the drugs. The exact number of visits and tests will be explained to you by the study team. You will continue to receive treatment for as long as it is working and you are tolerating it well. After treatment, there will be follow-up appointments to monitor your health over time. The total duration of your participation in the study, including follow-up, will vary depending on your response to treatment.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving new or different treatments for your multiple myeloma that might be more effective than other options. However, as with any medical treatment, there are potential risks and side effects associated with the study medications. The research team will discuss all known side effects with you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (216)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The University of Arizona Cancer Center
Verified postcode
Tucson, United States
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
Norwalk Hospital-oncology
Verified postcode
Norwalk, United States
MedStar Georgetown University Hospital
Verified postcode
Washington D.C., United States
George Washington University
Verified postcode
Washington D.C., United States
Memorial Healthcare System
Verified postcode
Hollywood, United States
University of Miami Health System
Verified postcode
Miami, United States
University Of Illinois
Verified postcode
Chicago, United States
University of Kansas
Verified postcode
Westwood, United States
Tulane University Hospital & Clinics
Verified postcode
New Orleans, United States
Ochsner Health System
Verified postcode
New Orleans, United States
Johns Hopkins University
Verified postcode
Baltimore, United States

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are part of your immune system and found in your bone marrow.

What does 'relapsed or refractory' mean?

It means the cancer has either come back after past treatments or is no longer responding well to the treatments you've had.

What are 'Talquetamab', 'Daratumumab', 'Pomalidomide', and 'Dexamethasone'?

These are names of different drugs used to treat multiple myeloma. Some are newer, and some are more commonly used.

How will I receive the treatments?

The treatments will be given as injections under the skin or as tablets, depending on the specific drug combination you receive.

Will I know which treatment I'm getting?

This is a 'blinded' study, meaning you won't know which specific combination you're getting until after the study is complete, to ensure fair results.