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RecruitingPHASE3INTERVENTIONAL

Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma

This research study is looking at a new treatment for a type of blood cancer called multiple myeloma. The new treatment involves a drug called cevostamab, given alongside two other medicines, pomalidomide and dexamethasone. We want to see how well this new combination works and if it's safe, compared to the standard treatments doctors already use. The study is for patients with multiple myeloma who have already tried one to three different treatments, including a specific type of drug called an anti-CD38 antibody, and another drug called lenalidomide. By taking part, you could help doctors learn more about the best ways to treat multiple myeloma.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Enrolment target
380
Start
23 Jun 2026
Estimated completion
31 Jan 2033

What is this study about?

This clinical trial is designed to investigate a new treatment approach for people living with multiple myeloma. Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell found in the bone marrow. The study is particularly interested in patients who have already received some previous treatments for their condition.

The main aim is to compare a new combination of medicines with the standard treatments currently available. The new combination includes a drug called cevostamab, given alongside pomalidomide and dexamethasone. The study will carefully check how effective this new combination is at treating multiple myeloma, and also look closely at its safety profile. By comparing it to standard care, researchers hope to find out if this new approach could offer a better option for patients.

Taking part in a study like this helps researchers understand new ways to fight diseases. The information gathered from participants can lead to new treatments becoming available in the future. It's important to remember that this is a research study, and while the aim is to find better treatments, there are no guarantees about the outcome for individuals.

Key takeaways

  • This study tests a new combination treatment for multiple myeloma.
  • It's for patients who have already had 1 to 3 previous treatments.
  • Compares a new drug (cevostamab) to existing standard treatments.
  • Aims to find out if the new treatment is more effective and safe.
  • Participation involves regular hospital visits and close medical monitoring.

Who may be eligible?

To join this study, you would need to have a confirmed diagnosis of multiple myeloma by an international standard. You should also have tried between one and three different treatments for your multiple myeloma in the past. These previous treatments must have included a specific type of drug (called an anti-CD38 antibody) and another drug called lenalidomide.

Doctors will also check your general health and how well you can carry out daily activities. You would need to be able to move around and do most everyday tasks without much difficulty. There will also be tests to make sure your multiple myeloma can be measured, so doctors can see if the treatment is working.

Some reasons you might not be able to join include having certain other serious health conditions like amyloidosis (another protein disorder), or if your multiple myeloma is affecting your brain or spinal cord. Also, if your cancer involves too many circulating cells in your blood, or if you have certain gut problems that might affect how you absorb medicines, you might not be eligible.

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?
  2. Have I already had 1 to 3 different treatments for my multiple myeloma?
  3. Did my previous treatments include an anti-CD38 drug AND lenalidomide?
  4. Am I generally well enough to do my daily activities (ECOG 0-1, or 2 due to pain)?
  5. Do I have measurable multiple myeloma (can doctors see it on tests)?
  6. Do I have any other serious conditions like amyloidosis or multiple myeloma affecting my brain/spinal cord?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to receive either the new treatment combination (cevostamab with pomalidomide and dexamethasone) or a standard treatment for multiple myeloma. The specific standard treatments used in the study include drugs like Daratumumab, Elotuzumab, or Carfilzomib, often combined with others. You won't get to choose which treatment group you are in; this is decided randomly, like flipping a coin, to ensure a fair comparison.

You will have regular hospital visits for check-ups, blood tests, and to receive your study medications. Some medications will be given by injection or through a drip, while others might be tablets you take at home. The medical team will closely monitor your health and any side effects throughout the study.

The total length of time you will be involved in the study will vary depending on how your multiple myeloma responds to the treatment. Treatment will continue for as long as it is benefiting you and you are tolerating it well. After treatment, you will have follow-up visits to check on your long-term health.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might receive a new treatment that could be more effective than existing ones, and you will be closely monitored by a dedicated medical team. However, the new treatment might not work as expected, or it could have side effects that are not yet fully known. Standard treatments also have their own potential side effects. There is also the chance that the new treatment isn't better than current options. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (93)

  • City of Hope National Medical Center
    Verified postcode
    Duarte, United States· Recruiting
  • City of Hope - Lennar Foundation Cancer Center
    Verified postcode
    Irvine, United States· Recruiting
  • Yale University
    Verified postcode
    New Haven, United States· Recruiting
  • MedStar Washington Hospital Center MedStar Georgetown Cancer Institute
    Verified postcode
    Washington D.C., United States· Recruiting
  • Emory University Hospital Midtown
    Verified postcode
    Atlanta, United States· Recruiting
  • Novant Health Cancer Institute
    Verified postcode
    Charlotte, United States· Recruiting
  • Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists
    Verified postcode
    Winston-Salem, United States· Recruiting
  • TriHealth Cancer and Blood Institute
    Verified postcode
    Cincinnati, United States· Recruiting
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • West Virginia University
    Verified postcode
    Morgantown, United States· Recruiting
  • St Vincent's Hospital Melbourne
    Verified postcode
    Fitzroy, Australia· Recruiting
  • The Alfred Hospital
    Verified postcode
    Melbourne, Australia· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects a specific kind of white blood cell, called plasma cells, found in your bone marrow.

What is 'standard of care'?

Standard of care refers to the best treatments that are currently available and widely accepted by doctors for a particular condition.

Why are previous treatments important for this study?

This study is specifically looking at treatments for patients whose multiple myeloma has come back or not responded fully after trying one to three different types of treatment.

What does 'Phase 3' mean for a clinical trial?

Phase 3 means the treatment has already been tested in smaller groups and is now being compared to existing treatments in a larger group of people to confirm its effectiveness and safety.

Will I know which treatment I'm getting?

In some parts of the study, you might not know if you're getting the new treatment or a standard one. This is to make sure the comparison is fair and unbiased.

How to find out more

Reference Study ID Number: CO46096 https://forpatients.roche.com/ No attachments to email below.

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 "Cevostamab in Combination With Pomalidomide and Dexamethason…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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