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RecruitingPHASE1INTERVENTIONAL

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

This study explores a new treatment combination for adults with multiple myeloma that has either returned after previous treatment (relapsed) or hasn't responded well to other therapies (refractory). The main goal is to understand how safe and tolerable the combination of two medicines, elranatamab and iberdomide, is when given together. There are two main parts: an initial phase to check for safety and side effects, and a second phase to find the best dose. Participants will receive elranatamab as an injection under the skin and take iberdomide tablets by mouth. The medicines are given in cycles, and treatment continues as long as it's helping and side effects are manageable. The study hopes to gather important information about these new medicines.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Pfizer
Enrolment target
87
Start
20 Feb 2024
Estimated completion
09 Mar 2028

What is this study about?

This study, called MagnetisMM-30, is designed to learn more about a new treatment approach for multiple myeloma. Myeloma is a type of cancer that affects white blood cells called plasma cells, which are found in your bone marrow. These cells normally help fight infections. When myeloma is "relapsed," it means the cancer has come back after a period of getting better. If it's "refractory," it means the cancer hasn't responded to earlier treatments.

The study combines two investigational medicines: elranatamab and iberdomide. Both are being tested to see if they can help people with multiple myeloma. Elranatamab will be given as an injection under the skin, and iberdomide will be taken as a tablet by mouth. The treatment will be given in cycles, which means you'll receive the medicine for a set period, then have a break, and then the cycle repeats.

The main aim of the study is to find out how safe these two medicines are when given together and to see if people can tolerate them well. There are two stages to the study: the first part focuses on safety, and the second part will help doctors determine the best dose of this combination. By taking part, you would be helping researchers understand if this new treatment could be a future option for multiple myeloma patients.

Key takeaways

  • This study is testing a new combination of medicines for multiple myeloma.
  • It's for people whose myeloma has come back or not responded to other treatments.
  • The primary aim is to check the safety and how well people tolerate the new treatment.
  • One medicine is an injection, the other is a tablet.
  • You can stop participating in the study at any time.

Who may be eligible?

This study is for adults who have been diagnosed with multiple myeloma. Importantly, your myeloma must have either returned after previous treatments or not responded well to other treatments. You would also need to have certain levels of specific proteins in your blood or urine, which doctors use to measure the activity of the myeloma.

To join, you generally need to have tried a certain number of treatments before – between one and four different lines of therapy, including specific types of medicines. You also need to be well enough to take part, meaning you can carry out most daily activities without too much difficulty, and any side effects from your previous treatments should have mostly cleared up.

There are also some reasons why you wouldn't be able to join. For example, if you have certain other serious health conditions, like severe heart problems or uncontrolled infections. You also can't have certain other types of cancer or have had a stem cell transplant very recently. If you've been treated with specific other medicines for myeloma in the past, or are taking certain drugs that might interfere with the study 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. Has my myeloma either come back or not responded to previous treatments?
  3. Am I generally well enough to manage daily activities?
  4. Have I had certain specific previous treatments for myeloma?
  5. Do I have any significant heart problems or uncontrolled infections?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicines in cycles, with each cycle lasting 28 days. Elranatamab will be given as an injection under your skin. Iberdomide will be a tablet you take by mouth once a day for 21 days within each 28-day cycle. You will continue to receive the study medicines for as long as they are helping you and as long as any side effects are manageable. You can also choose to stop participating at any time.

Throughout the study, you will have regular visits to the clinic for check-ups. These visits will involve blood tests to monitor your health and the activity of your myeloma, as well as checking for any side effects. The study team will carefully monitor your progress and well-being. There is no set total duration for this study, as treatment continues until there is significant disease progression, unacceptable side effects, or you decide to stop.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could help control your multiple myeloma, especially if other treatments haven't worked well. However, because these are experimental medicines, there's no guarantee it will help you. The main risk is that you might experience side effects from the medicines, which could be mild or severe. The study team will monitor you closely for any unwanted effects. You have the right to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (43)

  • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
    Verified postcode
    Coral Gables, United States· Recruiting
  • University of Miami Hospital and Clinics Deerfield Beach
    Verified postcode
    Deerfield Beach, United States· Recruiting
  • Sylvester Comprehensive Cancer Center- Doral
    Verified postcode
    Doral, United States· Recruiting
  • Sylvester Comprehensive Cancer Center
    Verified postcode
    Miami, United States· Recruiting
  • University of Miami Hospital and Clinics
    Verified postcode
    Miami, United States· Recruiting
  • Sylvester Comprehensive Cancer Center Kendall
    Verified postcode
    Miami, United States· Recruiting
  • Sylvester Comprehensive Cancer Center Plantation
    Verified postcode
    Plantation, United States· Recruiting
  • Emory University Hospital Midtown
    Verified postcode
    Atlanta, United States· Recruiting
  • Emory University Hospital
    Verified postcode
    Atlanta, United States· Recruiting
  • Winship Cancer Institute
    Verified postcode
    Atlanta, United States· Recruiting
  • Indiana CTSI Clinical Research Center (ICRC)
    Verified postcode
    Indianapolis, United States· Recruiting
  • Indiana University Health University Hospital
    Verified postcode
    Indianapolis, United States· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in the plasma cells, which are white blood cells found in your bone marrow.

What does 'relapsed or refractory' mean?

Relapsed means your myeloma has come back after treatment. Refractory means it hasn't responded well to previous treatments.

How will the medicines be given?

Elranatamab is an injection under the skin, and iberdomide is a tablet you take by mouth.

How long will I be in the study?

You'll continue treatment as long as it's helping and you're not having serious side effects, or unless you choose to stop.

What is the main goal of this study?

The main goal is to find out how safe and tolerable the combination of elranatamab and iberdomide is for people with multiple myeloma.

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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