All studies
RecruitingPHASE3INTERVENTIONAL

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

This research study is looking at two different medicines, Iberdomide and Lenalidomide, which are given as a 'maintenance' treatment after people with newly diagnosed multiple myeloma have had a stem cell transplant. The main goal is to compare how well each medicine works at preventing the cancer from coming back or getting worse. By taking part, you would help doctors understand which treatment might be more effective in the long term for people like you. This type of study helps improve future care for multiple myeloma patients.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Bristol-Myers Squibb
Enrolment target
1,216
Start
22 Jun 2023
Estimated completion
01 Jan 2036

What is this study about?

This study is designed to help us understand the best way to keep multiple myeloma under control after someone has gone through initial treatment, including a stem cell transplant. Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in the bone marrow. After a stem cell transplant, doctors often give 'maintenance' therapy to help prevent the cancer from returning quickly.

In this study, two different medicines are being compared: Iberdomide and Lenalidomide. Both are used to try and prevent the myeloma from recurring. We want to find out if one of these medicines is better than the other at keeping the cancer stable for a longer time. The medications are given for an extended period after the transplant. By comparing them directly in a large group of people, we can gather important information to guide future treatment choices for patients with newly diagnosed multiple myeloma.

Taking part in a study like this is a chance to contribute to medical knowledge and potentially help improve the care for people with multiple myeloma for years to come. Your involvement would be very valuable in working towards better outcomes for this condition.

Key takeaways

  • Compares two medicines (Iberdomide vs. Lenalidomide) after stem cell transplant for multiple myeloma.
  • Aims to find which treatment best prevents cancer recurrence.
  • For people recently diagnosed with multiple myeloma who have already had specific prior treatments.
  • Involves regular hospital visits for monitoring.
  • Helps improve future treatment for multiple myeloma patients.
  • You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must have been recently diagnosed with multiple myeloma and have already received a specific type of initial treatment. This includes receiving 3 to 6 cycles of induction therapy (which is typically a combination of medicines like proteasome inhibitors and immunomodulatory drugs, sometimes with another drug called a CD38 monoclonal antibody) and then had a stem cell transplant. You also need to have shown a good response to these treatments, meaning your myeloma has improved, and it must be within 12 to 15 months since you started your initial treatment.

You would not be able to join the study if your myeloma has started to get worse after your stem cell transplant, or if it didn't respond well to your primary treatment. Also, certain other conditions would prevent you from taking part, such as if your myeloma has spread to the brain or spinal cord, or if you have had other cancers in the last five years. The study team will check all your medical details carefully to make sure it's safe and appropriate for you to participate.

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 diagnosed with multiple myeloma?
  2. Have you had 3 to 6 cycles of initial chemotherapy (induction therapy)?
  3. Have you received a stem cell transplant?
  4. Has it been less than 12-15 months since you started your initial chemotherapy?
  5. Has your myeloma shown improvement after your transplant?
  6. Has your myeloma not gotten worse since your transplant?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be given either Iberdomide or Lenalidomide as your maintenance treatment after your stem cell transplant. You will likely take the medication regularly, as prescribed by the study doctors. You will have regular hospital visits for check-ups, blood tests, and to assess how you are responding to the treatment and to monitor for any side effects. These visits will continue for a set period and the total duration varies to ensure thorough monitoring and data collection.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from closer monitoring of your condition and access to a medication that could prove to be more effective than standard treatment. However, there are also risks, as both medicines can have side effects, and it's possible the new medicine might not work as well for you. The study team will explain all known side effects in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (285)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Rocky Mountain Cancer Centers
    Verified postcode
    Aurora, United States· Recruiting
  • Mayo Clinic Florida
    Verified postcode
    Jacksonville, United States· Recruiting
  • Tampa General Hospital
    Verified postcode
    Tampa, United States· Recruiting
  • H. Lee Moffitt Cancer Center & Research Institute
    Verified postcode
    Tampa, United States· Recruiting
  • Cleveland Clinic
    Verified postcode
    Weston, United States· Recruiting
  • University Cancer Blood Ctr
    Verified postcode
    Athens, United States· Recruiting
  • The Winship Cancer Institute of Emory University
    Verified postcode
    Atlanta, United States· Recruiting
  • Augusta University - Georgia Cancer Center
    Verified postcode
    Augusta, United States· Recruiting
  • The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
    Verified postcode
    Chicago, United States· Recruiting
  • University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
    Verified postcode
    Westwood, United States· Recruiting
  • Maryland Oncology Hematology, PA- Clinton
    Verified postcode
    Clinton, United States· Recruiting
  • UMass Memorial Medical Center
    Verified postcode
    Worcester, United States· Recruiting

Common questions

What is 'maintenance therapy'?

Maintenance therapy is a treatment given after initial intensive therapy, like a stem cell transplant, to help keep the cancer from coming back or getting worse for as long as possible.

What is a stem cell transplant?

A stem cell transplant (also called an autologous stem cell transplant) is a procedure using your own healthy stem cells to help your body recover after receiving high-dose chemotherapy for multiple myeloma.

What is multiple myeloma?

Multiple myeloma is a cancer of the plasma cells, a type of white blood cell found in the bone marrow. These abnormal cells can build up and cause problems in the bones, kidneys, and immune system.

Are Iberdomide and Lenalidomide new drugs?

Lenalidomide is an established treatment for multiple myeloma. Iberdomide is a newer drug in the same class, and this study aims to see how it compares for maintenance therapy.

Will I know which drug I'm receiving?

In studies like this, patients are often assigned to a treatment group by chance (like flipping a coin), and sometimes you might not know which drug you are receiving. The study team will explain this to you.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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 Compare Iberdomide Maintenance Versus Lenalidomid…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.