Active not recruitingPHASE2INTERVENTIONAL

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

This research study is about a new medication called teclistamab, designed for individuals living with multiple myeloma. This is a type of blood cancer that affects plasma cells. The study is particularly for those whose multiple myeloma has either returned after previous treatments (relapsed) or hasn't responded well to other therapies (refractory). The main goal is to find out how effective teclistamab is at a specific, recommended dose. By carefully studying its effects, researchers hope to understand if this new treatment could be a valuable option for patients who have limited choices left.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

194

Start

17 Sep 2020

Estimated completion

28 May 2027

Hematological Malignancies

What is this study about?

This study is looking into a new treatment called teclistamab for a type of blood cancer called multiple myeloma. Multiple myeloma affects important cells in your bone marrow. Sometimes, after initial treatments, the cancer can return (this is called relapsed) or it might not get better with the treatments tried so far (this is called refractory).

Teclistamab is designed to target specific cells involved in multiple myeloma. The researchers want to see how well this new medicine works in patients who have already had several other treatments, including specific types of drugs. They've identified a particular dose of teclistamab that they believe might be effective, and this study will help them confirm that.

The information gathered from this study is very important. It will help doctors understand more about teclistamab and whether it could become a new option for patients with multiple myeloma, especially those who have found their cancer hard to treat with existing therapies.

Key takeaways

This study is testing a new medicine, teclistamab, for multiple myeloma.
It's for people whose cancer has returned or didn't respond to other treatments.
The study aims to see how effective teclistamab is at a specific dose.
Participants must have tried several previous treatments for their multiple myeloma.
Careful monitoring of your health will be part of the study.

Who may be eligible?

To join this study, you would need to have a clear diagnosis of multiple myeloma that meets specific medical standards. Your general health and ability to perform daily activities would also be assessed, typically needing to be quite good. The study is for adults aged 18 and older, and it includes both men and women.

Critically, for some parts of the study, you must have already tried at least three different types of multiple myeloma treatments, including certain common medications like PIs, IMiDs, and anti-CD38 monoclonal antibodies. For other parts of the study, you would also need to have tried a treatment that targets something called BCMA.

There are also some reasons you wouldn't be able to join. For example, if you have other serious medical conditions like certain heart problems, lung issues needing oxygen, or certain infections (like HIV or hepatitis B/C). If you've recently had a stroke or seizure, or certain other types of blood cancers, you also wouldn't be able to participate. Also, you shouldn't have had other anti-cancer treatments too close to the start of the 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.

Do you have a clear diagnosis of multiple myeloma?
Are you 18 years old or older?
Have you already had at least three different types of multiple myeloma treatments?
Are you generally in good health otherwise?
Do you not have certain serious heart, lung, or infectious conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, teclistamab. The study will involve regular visits to the clinic so the medical team can monitor your health and how you are responding to the treatment. This will include blood tests, physical examinations, and possibly other scans or checks to see the effect on your multiple myeloma. You would need to follow specific instructions about the medication and any other study rules. The total duration of your participation would depend on how you respond to the treatment and the study's design.

Potential risks and benefits

Taking part in this study could offer the potential benefit of trying a new treatment for your multiple myeloma, especially if other treatments haven't worked well for you. However, as with any new medicine, there might be side effects or risks that are not fully known yet. The study team will carefully monitor you for any such effects. You should always discuss potential risks and benefits with your doctor. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (51)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
City of Hope
Verified postcode
Duarte, United States
University of California San Francisco
Verified postcode
San Francisco, United States
Stanford University Medical Center
Verified postcode
Stanford, United States
Winship Cancer Institute Emory University
Verified postcode
Atlanta, United States
Barbara Ann Karmanos Cancer Institute
Verified postcode
Detroit, United States
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
Verified postcode
New York, United States
Memorial Sloan-Kettering Cancer Center
Verified postcode
New York, United States
Levine Cancer Institute
Verified postcode
Charlotte, United States
University of Pennsylvania
Verified postcode
Philadelphia, United States
Universitair Ziekenhuis Gent - UZ GENT
Verified postcode
Ghent, Belgium
Universitaire Ziekenhuizen Leuven
Verified postcode
Leuven, Belgium

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are important white blood cells found in your bone marrow.

What does 'relapsed or refractory' mean?

It means your cancer has either come back after treatment or hasn't responded well to the treatments you've tried so far.

What is teclistamab?

Teclistamab is the name of the new medicine being tested in this study for treating multiple myeloma.

Is this a new treatment?

Yes, this is a 'Phase 2' study, which means it's still in the stages of being tested to see how well it works.

Will I get regular checks during the study?

Yes, you will have regular medical check-ups and tests to see how you're doing and how the treatment is affecting you.