All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

This research is investigating a new medication called teclistamab for people in the UK living with multiple myeloma. This is a type of blood cancer that affects plasma cells in the bone marrow. The study is comparing teclistamab against standard treatments (Pomalidomide, Bortezomib, Dexamethasone, or Carfilzomib, Dexamethasone) in individuals whose myeloma has either returned (relapsed) or hasn't improved with prior therapies (refractory). The main goals are to understand how effective teclistamab is at controlling the cancer and to monitor any side effects, ensuring the best possible care for patients.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Enrolment target
614
Start
29 Mar 2023
Estimated completion
31 Aug 2031

What is this study about?

This clinical trial is designed to help us learn more about a new medicine called teclistamab. It's being tested for people who have multiple myeloma, a type of blood cancer, that has come back after treatment or isn't responding to their current therapies. This can be a challenging situation, so finding new and effective treatments is very important.

Researchers want to see how teclistamab compares to some treatments that are already in use, specifically combinations of Pomalidomide, Bortezomib, and Dexamethasone (often called PVd) or Carfilzomib and Dexamethasone (Kd). By comparing these treatments, the study aims to understand if teclistamab offers a better way to manage the disease, looking at how well it works to reduce the cancer and what side effects people might experience.

The study has two main parts. The first part will directly compare teclistamab with the existing treatments, while the second part will take a closer look at teclistamab, including trying out different ways to give the medication to see if it makes treatment safer and more effective. This careful approach helps ensure that any new treatments are thoroughly tested and safe for patients.

Key takeaways

  • This study is for people with multiple myeloma that has come back or isn't responding to current treatments.
  • It's comparing a new drug, teclistamab, with standard treatments already in use.
  • The main goals are to see how well the new drug works and if it's safe.
  • You would need to have received 1 to 3 prior treatments for your myeloma.
  • Participation involves regular hospital visits for assessments and treatment.
  • You can stop participating in the study at any time.

Who may be eligible?

To join this study, you would need to have been diagnosed with multiple myeloma and it needs to be measurable, meaning doctors can track its progress through blood or urine tests. You should have already received between one and three different anti-cancer treatments for your myeloma, and these must have included a specific type of antibody treatment (anti-CD38 monoclonal antibody) and another medication called lenalidomide, each for at least two cycles. Importantly, your myeloma must have either progressed, meaning it's getting worse, or not responded well to your last treatment.

There are also some health checks you'd need to meet. Your general health and ability to perform daily activities would be assessed using a standard scale (ECOG performance status score of 0 to 2), indicating you're well enough to participate. If you are female, you must not be pregnant, breastfeeding, or planning to become pregnant during the study and for six months afterwards. You must also be able to follow the study's requirements and attend appointments.

However, some things would mean you couldn't join. For example, if you've already received any treatment specifically targeting something called BCMA, you wouldn't be eligible. Also, if you've previously taken pomalidomide, or have certain nerve issues (peripheral neuropathy), or specific allergies to the drugs used in the comparison treatment (PVd), you might not be able to participate. The study team will review all your medical information carefully to see if it's the right fit for you.

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. Is my multiple myeloma measurable by blood or urine tests?
  2. Have I had 1 to 3 previous treatments for my myeloma, including specific antibody therapy and lenalidomide?
  3. Has my myeloma worsened or not responded to my last treatment?
  4. Am I generally well enough to participate in a study (ECOG 0-2)?
  5. Have I ever received treatment specifically targeting 'BCMA'?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the new treatment, teclistamab, or one of the existing standard treatments (PVd or Kd). The treatment will be given according to a set schedule. You will have regular visits to the hospital for assessments such as blood tests, urine tests, and other health checks to monitor your progress and check for any side effects. These visits are important for the research team to understand how the treatment is working for you. You will also have ongoing contact with the study team to discuss your health and any concerns you might have. The total duration of your participation, including follow-up after the main treatment period, will depend on your individual response and the study protocol, but the team will explain this clearly before you start.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and potential risks. You might benefit by receiving a new treatment that could be more effective for your multiple myeloma than existing therapies, and you'll receive close medical monitoring throughout the study. However, there's no guarantee that the treatment will work for you, and all medications carry a risk of side effects, which the study team will monitor closely. You will be fully informed about all known potential risks before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (211)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Alaska Oncology and Hematology LLC
    Verified postcode
    Anchorage, United States
  • Banner MD Anderson Cancer Center
    Verified postcode
    Gilbert, United States
  • Alta Bates Comprehensive Cancer Center
    Verified postcode
    Berkeley, United States
  • MemorialCare Long Beach Medical Center
    Verified postcode
    Long Beach, United States
  • University of California Irvine
    Verified postcode
    Orange, United States
  • PIH Health Hospital
    Verified postcode
    Whittier, United States
  • Rocky Mountain Cancer Centers
    Verified postcode
    Aurora, United States
  • University of Connecticut
    Verified postcode
    Farmington, United States
  • University of Miami Sylvester Cancer Center
    Verified postcode
    Miami, United States
  • Orlando Health Cancer Institute
    Verified postcode
    Orlando, United States
  • Cleveland Clinic Florida
    Verified postcode
    Weston, United States
  • Mission Cancer Blood
    Verified postcode
    Waukee, United States

Common questions

What is multiple myeloma?

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

What does relapsed or refractory mean?

Relapsed means the cancer has returned after treatment, and refractory means the cancer has not responded to previous treatments.

What is teclistamab?

Teclistamab is an investigational new drug being tested to treat multiple myeloma.

Will I receive the new drug or standard treatment?

Participants will be assigned by chance to either receive teclistamab or one of the standard treatment combinations (PVd or Kd).

Can I leave the study at any time?

Yes, your participation is voluntary, and you can withdraw from the study at any point without impacting your usual 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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