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RecruitingPHASE3INTERVENTIONAL

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

This important study is for people recently diagnosed with multiple myeloma, a cancer of the plasma cells in your bone marrow. After you’ve had a stem cell transplant, this study aims to find out if new treatments can help keep the cancer away. We are comparing teclistamab, a new medicine, given either on its own or with another drug called lenalidomide, against just lenalidomide. The goal is to see which treatment is most effective at preventing the multiple myeloma from returning after your initial treatment. This is a Phase 3 study, meaning these treatments have already shown promise in earlier research, and we now want to confirm their benefits on a larger scale.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
European Myeloma Network B.V.
Enrolment target
1,594
Start
08 Sep 2022
Estimated completion
01 Apr 2032

What is this study about?

This study is a Phase 3 clinical trial, which means it's one of the final steps in testing new medications before they can become widely available. It's designed for people who have recently been diagnosed with multiple myeloma and have already undergone initial treatment, including a stem cell transplant. After a transplant, it's common to receive ongoing 'maintenance' treatment to help keep the cancer in check. This study is exploring new options for this maintenance phase.

We are looking at two treatment approaches: teclistamab on its own, and teclistamab combined with lenalidomide. These will be compared against the standard treatment of lenalidomide alone. Teclistamab is a type of drug that helps your own immune system find and fight cancer cells. By comparing these different approaches, doctors hope to find a more effective way to prevent multiple myeloma from returning or worsening after a stem cell transplant.

The main goal of the study is to see which of these treatments best helps people stay free from their cancer for longer. Understanding these benefits will help doctors make better decisions about care for people with multiple myeloma in the future.

Key takeaways

  • This study is for people with recently diagnosed multiple myeloma who have had a stem cell transplant.
  • It compares teclistamab (alone or with lenalidomide) against lenalidomide alone as maintenance therapy.
  • The aim is to find better ways to prevent multiple myeloma from returning after a transplant.
  • Participation involves receiving new treatments and regular health check-ups.
  • You can stop participating at any time if you wish.

Who may be eligible?

To be part of this study, you must have been recently diagnosed with multiple myeloma and have already had initial treatment, including a stem cell transplant. Your cancer must have improved after your first treatment, showing at least a partial response, and not gotten worse since then. You also shouldn't have had any maintenance treatment for multiple myeloma yet.

There are also some health requirements. For example, you need to be generally well enough to take part, as shown by certain health checks. Your blood test results must be within an acceptable range, and you shouldn't have any serious side effects from previous lenalidomide treatment that made you stop taking it.

People who have previously received certain types of cancer treatments or therapies that specifically target a protein called BCMA (which is involved in multiple myeloma) usually cannot join this study. Also, if your multiple myeloma got worse at any point before this study, or if you've recently had a live vaccine, you might not be eligible. The study is open to both men and women, aged 18 and over.

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 I been diagnosed with multiple myeloma recently?
  2. Have I already had a stem cell transplant?
  3. Has my multiple myeloma improved reasonably well after my first treatment?
  4. Have I not yet started any maintenance therapy for my multiple myeloma?
  5. Am I generally well enough to take part in a study?
Answer every question to see your result.

What does participation involve?

The detailed information on what taking part involves is not provided in the summary. However, in a typical Phase 3 study like this, you would be randomly assigned to one of the treatment groups (teclistamab alone, teclistamab plus lenalidomide, or lenalidomide alone). You would receive your assigned treatment for a period determined by the study. This would involve regular visits to the clinic for check-ups, blood tests, and to receive your medication. There would also be follow-up appointments to monitor your health and the effects of the treatment. The total duration of the study, including treatment and follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as receiving new treatments that aren't widely available yet and contributing to medical knowledge. However, there are also potential risks, including side effects from the study drugs – some of which might be unknown. Your doctor will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (212)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Banner University Medical Center Tucson, University of Arizona
    Verified postcode
    Phoenix, United States· Recruiting
  • UCLA Medical Center
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • University of California-Davis Cancer Center
    Verified postcode
    Sacramento, United States· Recruiting
  • University of California, San Diego (UCSD) Medical Center
    Verified postcode
    San Diego, United States· Recruiting
  • University of Colorado Hospital
    Verified postcode
    Aurora, United States· Recruiting
  • Colorado Blood Cancer Institute
    Verified postcode
    Denver, United States· Recruiting
  • Yale New Haven Hospital
    Verified postcode
    New Haven, United States· Recruiting
  • Christiana Care
    Verified postcode
    Newark, United States· Recruiting
  • Sibley Memorial Hospital
    Verified postcode
    Washington D.C., United States· Recruiting
  • AdventHealth/Blood & Marrow Transplant Center, Florida Hospital Medical Group
    Verified postcode
    Orlando, United States· Recruiting
  • Moffitt at Memorial Healthcare System
    Verified postcode
    Tampa, United States· Recruiting
  • Emory University Hospital
    Verified postcode
    Atlanta, United States· Recruiting

Common questions

What is multiple myeloma?

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

What is a stem cell transplant?

A stem cell transplant is a procedure that replaces damaged bone marrow with healthy blood-forming stem cells, often used in treating multiple myeloma.

What does 'maintenance therapy' mean?

Maintenance therapy is ongoing treatment given after the main cancer treatment (like a transplant) to help keep the cancer from coming back or growing.

What is teclistamab?

Teclistamab is a new type of drug that helps your body's own immune system fight multiple myeloma cells.

What does 'Phase 3 study' mean?

A Phase 3 study tests if a new treatment is better than existing ones, and is usually one of the last steps before a treatment can be approved for wider use.

How to find out more

Christine Witty

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

Interested in taking part?

Register your interest

Share your details and the research team for "Phase 3 Study of Teclistamab in Combination With Lenalidomid…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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