All studies
Active not recruitingPHASE1INTERVENTIONAL

A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

This research is focused on a medicine called Teclistamab, used for people in the UK with multiple myeloma, a type of blood cancer, that has come back or not responded to other treatments. The company that makes Teclistamab has created a new way to produce it. This study aims to compare how the original Teclistamab (pre-change) and the newly made Teclistamab (post-change) behave in the body. This includes how much of the medicine gets into your system, how it moves around, and how it eventually leaves. The goal is to make sure the new manufacturing process doesn't change how the medicine works, so it remains just as safe and effective for patients.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Janssen Research & Development, LLC
Enrolment target
108
Start
07 Jun 2024
Estimated completion
03 Mar 2027

What is this study about?

This study is about a medicine called Teclistamab. It's used to treat a type of blood cancer called multiple myeloma, specifically when the cancer has returned or hasn't responded to previous treatments. Think of it like this: Teclistamab is designed to fight cancer cells, and it's an important treatment option for many.

The company that makes Teclistamab has started using a new method to produce the medicine. It's really important to make sure that even with a new making process, the medicine still works exactly the same way in a person's body. This study will carefully compare the original version of Teclistamab (made the 'old' way) with the new version (made the 'new' way).

Researchers will observe how the medicine is absorbed into your body, how it travels around, and how it's eventually removed. This is like understanding the medicine's journey from when you take it until it leaves your system. By doing this, we can be confident that the newly manufactured Teclistamab is just as safe and effective as the original, ensuring patients continue to receive the best possible care.

Key takeaways

  • The study is about a new way of making Teclistamab, a multiple myeloma medicine.
  • It aims to check if the 'new' Teclistamab works the same as the 'old' one in your body.
  • Participants must have relapsed or refractory multiple myeloma and have had specific prior treatments.
  • Close medical monitoring and regular tests will be part of the study.
  • You can withdraw from the study at any point.
  • This research helps ensure the continued safety and effectiveness of this important medicine.

Who may be eligible?

To join this study, you must have been diagnosed with multiple myeloma and it needs to be what doctors call 'measurable.' This means we can see evidence of the cancer through blood or urine tests. You should have already tried between one and three different treatments for your myeloma, including certain types of medicines like a 'proteasome inhibitor,' 'lenalidomide,' and an 'anti-CD38 antibody.' These previous treatments also need to have not worked for your cancer, or your cancer might have gotten worse after them.

There are also some things that would mean you couldn't take part. For example, if you've already had certain types of advanced cell therapies (like bispecific antibodies or CAR-T cell therapy), or if you have severe allergies to the study medicine. You also can't have had a live vaccine recently, and the cancer shouldn't have spread to your brain or spinal cord.

Women who could become pregnant would need to have specific pregnancy tests and agree to continue them during the study. Generally, participants must be at least 18 years old and be well enough to take part in a study, as assessed by a doctor.

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. Have you been diagnosed with multiple myeloma that is currently 'measurable'?
  2. Have you already tried between one and three different treatments for your myeloma, including specific ones like a proteasome inhibitor, lenalidomide, and an anti-CD38 antibody?
  3. Did your myeloma get worse or not respond to your last treatment?
  4. Are you generally well enough to take part in a study, as judged by your doctor?
  5. Have you NOT had certain advanced cell therapies (like CAR-T) before?
  6. Do you NOT have serious allergies to any drugs or recent live vaccinations?
Answer every question to see your result.

What does participation involve?

If you join this study, it involves taking the medicine Teclistamab. You'll have regular hospital visits for assessments, which will include blood and urine tests to monitor your health and how the medicine is working. These tests will also help us understand how the new version of Teclistamab behaves in your body compared to the old one. There will likely be physical exams and other checks to make sure you're tolerating the treatment well. The total duration of your participation will depend on how you respond to the treatment and the study's requirements for follow-up.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new version of an effective cancer treatment under close medical supervision. However, there's always a chance of side effects from the medication, and the new manufacturing process might, though unlikely, lead to unexpected differences. The good news is that you'll be carefully monitored by a healthcare team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (53)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Banner MD Anderson Cancer Center
    Verified postcode
    Gilbert, United States
  • Colorado Blood Cancer Institute
    Verified postcode
    Denver, United States
  • Cleveland Clinic Florida
    Verified postcode
    Weston, United States
  • Augusta University- Georgia Cancer Center
    Verified postcode
    Augusta, United States
  • St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health
    Verified postcode
    Indianapolis, United States
  • Cleveland Clinic
    Verified postcode
    Cleveland, United States
  • Baylor University Medical Center
    Verified postcode
    Dallas, United States
  • Flinders Medical Centre
    Verified postcode
    Bedford Park, Australia
  • Box Hill Hospital
    Verified postcode
    Box Hill, Australia
  • Royal Prince Alfred Hospital
    Verified postcode
    Camperdown, Australia
  • Epworth Healthcare
    Verified postcode
    Richmond, Australia
  • Cross Cancer Institute
    Verified postcode
    Edmonton, Canada

Common questions

What is multiple myeloma?

It's a type of blood cancer that affects plasma cells in your bone marrow.

What is Teclistamab?

It's a specific medicine used to treat multiple myeloma, especially when other treatments haven't worked or the cancer has returned.

Why is the company making a new version of Teclistamab?

Companies sometimes update their manufacturing processes for various reasons, but they need to ensure the medicine remains the same in terms of how it works.

Will I know if I'm getting the 'old' or 'new' version?

The study is designed to compare both versions, and the study team will have details on how this is managed ethically and scientifically.

Can I stop taking part if I change my mind?

Yes, you can leave the study at any time, and it won't impact your ongoing medical care.

How to find out more

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

Discussion

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