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RecruitingPHASE3INTERVENTIONAL

A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant

This study is for adults newly diagnosed with multiple myeloma who are not suitable for a stem cell transplant. Doctors are comparing two different drug combinations to see which works best. One combination includes a new medicine called Elranatamab, alongside Daratumumab and Lenalidomide. The other combination, which is more common, uses Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone. The main goal is to find out if the Elranatamab combination is more effective at stopping the cancer from growing and improving overall health. The study also looks at the safety of the new combination and how well patients tolerate it. It's hoped that the new treatment could offer a better option for people with this type of blood cancer.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Pfizer
Enrolment target
1,116
Start
10 Nov 2022
Estimated completion
03 Oct 2033

What is this study about?

This research study is looking into new ways to treat multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. Specifically, it's for people who have recently been diagnosed and are not able to have a stem cell transplant, often due to their age or other health conditions.

The study compares two different treatment approaches. One approach uses a combination of drugs called Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone – this is a well-known treatment option. The other approach introduces a newer drug called Elranatamab, combined with Daratumumab and Lenalidomide. Elranatamab works by helping your body's immune system target and kill the myeloma cells.

The main purpose of this study is to see if the new combination (involving Elranatamab) can provide a better outcome for patients compared to the standard treatment. The researchers want to understand if it's more effective at reducing or getting rid of the cancer cells, preventing the cancer from returning, and how well people tolerate the treatment. This research could potentially lead to improved treatment options for people with multiple myeloma.

Key takeaways

  • This study compares two treatments for newly diagnosed multiple myeloma.
  • It's for people who cannot have a stem cell transplant.
  • One treatment includes a new drug called Elranatamab.
  • The study aims to find out if the new treatment is more effective.
  • Participants will have regular check-ups and monitoring.
  • You can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have been recently diagnosed with multiple myeloma. A key requirement is that you are not suitable for a stem cell transplant, either because of your age (usually 65 or older) or other health problems that make a transplant too risky. You would also need to have clear signs of multiple myeloma that can be measured by your doctor.

There are certain reasons why you might not be able to join. For example, if you have other types of blood conditions like smoldering multiple myeloma or Waldenström's Macroglobulinemia. Additionally, if you have an active, uncontrolled infection (like a serious bacterial, fungal, or viral infection, including HIV or serious COVID-19), or another active cancer that isn't completely cured, you wouldn't be able to participate. If you've previously had a specific type of treatment that targets BCMA this might also stop you from joining.

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 newly diagnosed with multiple myeloma?
  2. Has your doctor said you are not suitable for a stem cell transplant?
  3. Are you 18 years old or over?
  4. Do you have measurable signs of multiple myeloma (e.g., in blood or urine tests)?
  5. Do you have an OK general health status (ECOG performance status of 0, 1 or 2)?
  6. Do you currently have any serious, uncontrolled infections or another active cancer?
Answer every question to see your result.

What does participation involve?

If you join this study, the doctors will first make sure the new drug combination is safe. Then, you will be given either the new combination treatment or the standard treatment. Both treatments involve taking several different medications, some of which may be given as injections or infusions, and others as tablets. You would have regular appointments at the hospital for check-ups, blood tests, and to receive your medication. The doctors will closely monitor how you're responding to the treatment and for any side effects. The exact number of visits and the total length of time you'd be involved can vary, but studies like this usually involve follow-up for several years to track your long-term health and the cancer's progress.

Potential risks and benefits

Taking part in this study might offer the benefit of receiving a potentially more effective treatment for your multiple myeloma. However, there's no guarantee the new treatment will work better than existing options. There are also potential risks involved, as all medications can have side effects. Doctors will monitor you closely for any reactions, which could range from mild to serious. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (121)

  • Jupiter Medical Center/Anderson Family Cancer Institute
    Verified postcode
    Jupiter, United States· Not yet recruiting
  • MSK Basking Ridge
    Verified postcode
    Basking Ridge, United States· Recruiting
  • MSK Monmouth
    Verified postcode
    Middletown, United States· Recruiting
  • MSK Bergen
    Verified postcode
    Montvale, United States· Recruiting
  • MSK Commack
    Verified postcode
    Commack, United States· Recruiting
  • MSK Westchester
    Verified postcode
    Harrison, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
    Verified postcode
    New York, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center - Main Campus
    Verified postcode
    New York, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center-Main Campus
    Verified postcode
    New York, United States· Recruiting
  • MSK Nassau
    Verified postcode
    Uniondale, United States· Recruiting
  • The University of Texas MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • Pindara Private Hospital
    Verified postcode
    Benowa, Australia· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in the bone marrow, affecting specialized white blood cells called plasma cells.

What is a stem cell transplant?

A high-dose stem cell transplant is an intensive treatment that aims to get rid of cancer cells by replacing your bone marrow with healthy stem cells. It's not suitable for everyone.

What does 'newly diagnosed' mean?

This means you have only recently been told you have multiple myeloma and have not yet received extensive treatment for it.

What is Elranatamab?

Elranatamab is a new type of drug being tested that helps your immune system find and kill the myeloma cancer cells.

Will I know which treatment I'm getting?

In some parts of the study, you might not know which treatment you are receiving, as this helps researchers compare the treatments fairly. However, your doctors will always provide the best care for you.

How to find out more

Pfizer CT.gov Call Center

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 to Learn About the Effects of the Combination of Elr…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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