Active not recruitingPHASE1INTERVENTIONAL

A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

This research study is about a new drug called talquetamab, which is being tested in people who have multiple myeloma. Doctors want to see how safe talquetamab is when given along with other common cancer medicines like Carfilzomib, Daratumumab, Lenalidomide, and Pomalidomide. They are also trying to find the best and safest amounts (doses) of these drug combinations to give. This is an early-stage study (Phase 1), which means they are carefully checking for any side effects and how the body handles the new treatment combinations before moving on to larger studies.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Janssen Research & Development, LLC

Enrolment target

166

Start

22 Sep 2021

Estimated completion

13 Oct 2027

Multiple Myeloma

What is this study about?

This study is investigating a new treatment approach for multiple myeloma, a type of blood cancer that affects your bone marrow. The main focus is on a new medicine called talquetamab. Researchers want to understand how safe this new drug is when it's given together with other treatments that are already used for multiple myeloma. They will be looking at different combinations of talquetamab with drugs like Carfilzomib, Daratumumab, Lenalidomide, and Pomalidomide.

The main aim is to find out which doses of these combinations are safe for people to take and to observe any side effects. This is a very important first step in developing new treatments. By finding safe doses, future studies can then focus more on how well these combinations work at fighting the cancer.

Taking part in a study like this helps doctors learn more about new medicines. This knowledge can then be used to help future patients with multiple myeloma. It's an opportunity to contribute to medical science and potentially benefit from new treatments that aren't yet widely available.

Key takeaways

The study is testing a new drug called talquetamab for multiple myeloma.
It's looking at talquetamab combined with other existing cancer treatments.
The main goal is to find safe doses and understand any side effects of these combinations.
This is an early-stage study (Phase 1) focused on safety.
Participants will receive close medical monitoring throughout the study.

Who may be eligible?

To join this study, you must have been diagnosed with multiple myeloma and your doctors need to be able to measure your cancer – for example, through blood or urine tests. You should also generally be well enough to take part in a study, meaning you can perform most of your usual daily activities without too much difficulty.

There are some reasons why you might not be able to join. For example, if you've recently had certain vaccines or have received a high dose of steroid medicines in the past two weeks. Also, if your multiple myeloma is affecting your brain or spinal cord, or if you have certain other serious medical conditions like a history of stroke or seizures within the last six months, you wouldn't be able to participate. Women must also meet specific pregnancy prevention requirements.

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.

Have I been diagnosed with multiple myeloma?
Can my doctors measure my cancer in blood or urine tests?
Am I generally well enough to do most of my normal daily activities?
Have I had any live vaccines within the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive talquetamab along with one of the other mentioned anticancer therapies. You'll have regular appointments at the hospital or clinic where the research team will monitor your health very closely. These appointments will involve physical exams, blood tests, and other checks to see how you are responding to the treatment and to keep an eye on any side effects.

The specific number of visits and tests will vary depending on which treatment combination you receive and how long you are on the study. The study team will explain everything in detail, including how long you are expected to receive treatment and any follow-up appointments after that. The total duration of participation will depend on how you respond to the treatment and the study plan, but detailed information will be provided before you agree to participate.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to new treatments like talquetamab that are not yet widely available. You will also receive careful medical monitoring throughout the study. However, there are also potential risks; new treatments can have side effects that are not yet fully known, and the treatment might not work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (31)

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

University of Alabama Birmingham
Verified postcode
Birmingham, United States
University of California San Francisco
Verified postcode
San Francisco, United States
Colorado Blood Cancer Institute
Verified postcode
Denver, United States
Emory University
Verified postcode
Atlanta, United States
Indiana University
Verified postcode
Indianapolis, United States
Hackensack University Medical Center
Verified postcode
Hackensack, United States
Mt. Sinai School of Medicine
Verified postcode
New York, United States
Weill Cornell Medical College
Verified postcode
New York, United States
Levine Cancer Institute
Verified postcode
Charlotte, United States
University of Pittsburgh Medical Center
Verified postcode
Pittsburgh, United States
Tennessee Oncology
Verified postcode
Nashville, United States
Medical College Of Wisconsin
Verified postcode
Milwaukee, United States

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. These cells are important for fighting infections.

What is talquetamab?

Talquetamab is a new investigational drug being studied for multiple myeloma. It's designed to help your immune system fight the cancer cells.

Why combine talquetamab with other drugs?

Doctors often combine different drugs to treat cancer. Sometimes, drugs work better together than alone, potentially leading to more effective treatment and fewer side effects.

What does 'Phase 1' mean?

Phase 1 is the first stage of human testing for a new drug. The main goal at this stage is to check if the treatment is safe and to find the best dose, rather than how effective it is yet.

Will I get to choose which combination therapy I receive?

In early phase studies like this, the study doctors typically decide which combination you will receive based on the study design and your medical background.