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RecruitingPHASE3INTERVENTIONAL

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

This research study is for people who have recently been diagnosed with multiple myeloma, a cancer of the blood, and are not suitable for a stem cell transplant. We are comparing two new combinations of medicines: one with Teclistamab and standard drugs (Daratumumab and Lenalidomide), and another with Talquetamab and the same standard drugs. These combinations are being compared to the existing standard treatment which uses Daratumumab, Lenalidomide, and Dexamethasone. The main goal is to find out if these new combinations are more effective than the current standard treatment in fighting multiple myeloma. Participants will be closely monitored, and all treatments are given under careful medical supervision.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Enrolment target
1,590
Start
25 Oct 2022
Estimated completion
28 Oct 2033

What is this study about?

When someone is diagnosed with multiple myeloma, which is a cancer affecting certain white blood cells, doctors work out the best treatment plan. For some people, a stem cell transplant might be an option, but for others, it's not suitable due to age or other health conditions. This study focuses on these individuals who are unable to have a stem cell transplant right away.

The study is testing two new approaches. Both new approaches combine a relatively new drug (either Teclistamab or Talquetamab) with two drugs that are already commonly used for multiple myeloma: Daratumumab and Lenalidomide. These two new combinations are being compared to the existing standard treatment, which uses Daratumumab, Lenalidomide, and a steroid called Dexamethasone. The aim is to see if these newer combinations can work better than what's currently available.

By comparing these different treatment plans, doctors hope to find more effective ways to manage multiple myeloma for patients who cannot have a stem cell transplant. This could lead to better outcomes and quality of life for people living with this condition.

Key takeaways

  • The study is for people with newly diagnosed multiple myeloma not suitable for an initial stem cell transplant.
  • It compares two new drug combinations with a standard treatment.
  • The goal is to find more effective ways to treat multiple myeloma.
  • Participation involves regular clinic visits for treatment and monitoring.
  • You'll receive close medical attention throughout the study.

Who may be eligible?

To join this study, you must have recently been diagnosed with multiple myeloma. It's important that your doctor has decided that a high-dose chemotherapy treatment with a stem cell transplant isn't the right first step for you, either because of your age or other health issues, or if you're choosing to delay that treatment.

You also need to be generally well enough to take part. This means your daily activities shouldn't be too limited by your health. Both men and women aged 18 and over can participate. If you're a woman, you must not be pregnant, breastfeeding, or planning to become pregnant during the study and for six months afterwards. If you're a man, you must not plan to father a child during the study and for 100 days after your last treatment dose.

There are also some reasons why you might not be able to join. For example, if you've already had treatment for multiple myeloma (other than a very short course of steroids), or if you've had certain medical events like a stroke recently. Also, if you have known allergies to any of the study medications, or certain severe health conditions, you wouldn't be able to take part.

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 recently been diagnosed with multiple myeloma?
  2. Has my doctor said a stem cell transplant isn't suitable for me right now?
  3. Am I aged 18 or over?
  4. Am I generally well enough to participate in daily activities?
  5. Am I willing to use contraception (if applicable) during and after the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of three treatment groups. This decision is made randomly, like flipping a coin. You will receive either Teclistamab with Daratumumab and Lenalidomide, Talquetamab with Daratumumab and Lenalidomide, or Daratumumab, Lenalidomide, and Dexamethasone. You will receive regular doses of these medications, which will involve visits to the clinic for treatments and check-ups.

Throughout the study, you will have regular medical appointments, blood tests, and other examinations to monitor your health, how the treatment is working, and to check for any side effects. This will help the doctors understand the effects of the treatments. The total length of the study for each participant will vary, but it involves ongoing treatment cycles followed by a follow-up period to monitor your long-term health. You will be given a detailed schedule by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and close medical monitoring. However, there are also potential risks, including side effects from the medications, which can vary from mild to serious and may be new or unexpected. Your health will be carefully watched, and the medical team will be there to support you. It's important to remember that joining a study is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (265)

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· Recruiting
  • University of Arizona Cancer Center
    Verified postcode
    Tucson, United States· Recruiting
  • UCSF Fresno
    Verified postcode
    Clovis, United States· Recruiting
  • City of Hope Duarte
    Verified postcode
    Duarte, United States· Recruiting
  • City of Hope Orange County Lennar Foundation Cancer Center
    Verified postcode
    Irvine, United States· Recruiting
  • Cancer and Blood Specialty Clinic
    Verified postcode
    Los Alamitos, United States· Recruiting
  • Valkyrie Clinical Trials
    Verified postcode
    Los Angeles, United States· Recruiting
  • University of Connecticut
    Verified postcode
    Farmington, United States· Recruiting
  • Yale New Haven Hospital
    Verified postcode
    New Haven, United States· Recruiting
  • ChristianaCare Helen F Graham Cancer Center and Research Institute
    Verified postcode
    Newark, United States· Recruiting
  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando
    Verified postcode
    Orlando, United States· Recruiting
  • Cleveland Clinic Florida
    Verified postcode
    Weston, United States· Recruiting

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 normally help fight infections.

What does 'newly diagnosed' mean in this study?

It means you have recently been told you have multiple myeloma and haven't had any previous treatment for it, except for a very short course of steroid medicines if needed.

What is a 'stem cell transplant' and why might I not be suitable for it?

A stem cell transplant is an intensive treatment that can be used for multiple myeloma. Some people might not be suitable if they are older, have other ongoing health problems, or choose to delay this particular treatment.

Will I know which treatment I am receiving?

No, this study is 'blinded,' meaning neither you nor your study doctor will know which specific treatment combination you are getting until the study is over, or in certain medical situations.

How long will I be on the treatment?

The length of treatment varies for each person and will be discussed with you by the study team, but it involves multiple cycles of medication and follow-up.

How to find out more

Study Contact

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 "A Study of Teclistamab in Combination With Daratumumab and L…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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