Study of etentamig and iberdomide treatment for patients with relapsed or refractory multiple myeloma

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What is this study about?

This study focuses on treating Multiple Myeloma that has returned or stopped responding to previous treatments, known as Relapsed/Refractory Multiple Myeloma. Multiple Myeloma is a type of blood cancer that affects plasma cells, which are cells in the bone marrow that help fight infections. The study will test a combination of two medications: etentamig and iberdomide (also known as CC-220).

The purpose of this research is to understand how safe and tolerable these medications are when given together, and to find the most appropriate dose combination for patients. During the study, patients will receive etentamig along with iberdomide capsules taken by mouth. Some patients will also receive iberdomide through an eye drop solution, while others will receive it through intravenous administration (given directly into a vein).

The study will monitor how patients respond to the treatment by checking if the cancer improves, stays the same, or gets worse. Doctors will track various aspects of the disease response, including how long the treatment works and whether any cancer cells remain in the body. Throughout the study, patients will have regular check-ups to monitor their health and any side effects from the treatment.

1 Initial evaluation

Your diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) will be confirmed through laboratory tests

Your physical condition will be assessed using the ECOG performance scale (a measure of your ability to perform daily activities)

Laboratory tests will be conducted to measure your disease levels

2 Treatment administration

You will receive two medications during the study:

Etentamig administered through intravenous infusion (through a vein)

Iberdomide taken as oral capsules

The doses of both medications will be determined during the study

3 Monitoring phase

Regular assessments will track your response to treatment through:

Blood tests to measure disease levels

Evaluation of any side effects

Measurement of remaining disease levels in your body

Assessment of how long the treatment remains effective

4 Response evaluation

Your response to treatment will be classified as one of the following:

Partial Response (PR): some improvement in disease levels

Very Good Partial Response (VGPR): significant improvement in disease levels

Complete Response (CR): no detectable disease using standard tests

Stringent Complete Response (sCR): most thorough level of disease elimination

5 Long-term follow-up

Monitoring will continue to track:

How long the treatment effects last

Time until the disease shows signs of returning

Your overall health status

The study may continue until March 2036

Who Can Join the Study?

Age requirement: Adults aged 18-64 years old and elderly people aged 65 and above can participate
Must have a confirmed diagnosis of Multiple Myeloma that has returned or not responded to previous treatment
Must have a good level of physical fitness and ability to perform daily activities, scoring either:
- 0 (fully active, able to perform all activities without restriction) or
- 1 (restricted in physically strenuous activity but able to walk and do light work) on the ECOG scale
Must have measurable disease that can be evaluated through laboratory tests
Both men and women can participate in the study

Who Cannot Join the Study?

Prior history of plasma cell leukemia (a condition where abnormal plasma cells are found in the blood)
Active central nervous system involvement (cancer spread to brain or spinal cord)
Previous treatment with iberdomide
Known allergic reactions to similar medications
Pregnant or breastfeeding women
Significant heart problems or uncontrolled high blood pressure
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Major surgery within 4 weeks before starting the study
Participation in other clinical trials within 28 days before this study
Severe kidney or liver problems
Any other medical condition that could make participation unsafe
Unable to take blood-thinning medications
History of other cancers within the past 3 years (except for successfully treated skin cancer or early-stage cancer)
Mental conditions that could affect ability to follow study requirements

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Oslo Universitetssykehus HF	Oslo	Norway
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Centre Hospitalier Universitaire De Nice	Nice	France
Agvghexfv Uaq	Amsterdam	The Netherlands
Adwuleuldy Pkxabkgh Haewjbtl Dh Mjqifrkui	Marseille	France
Eedsblt Ufojaxkcexei Mvxkxan Cymnbff Rrurayexq (afbrigy Mex	Rotterdam	The Netherlands
Ctrvaj Hnbjfflqatb Rmbkekcw Ulwmvtqkqvdsv Dn Tdbkc	Tours	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	30.06.2025
Norway	Recruiting	30.06.2025
The Netherlands	Recruiting	30.06.2025

Trial locations

Investigated drugs:

Iberdomide

Etentamig is an investigational medication being studied for the treatment of multiple myeloma that has returned or stopped responding to previous treatments. It is being tested as part of a combination therapy approach for patients with relapsed or refractory multiple myeloma.

Iberdomide is a CELMoD (Cereblon E3 Ligase Modulation) agent that works by affecting the immune system to fight multiple myeloma cells. It belongs to a newer class of drugs that help modify the body’s immune response to fight cancer cells.

These medications are being studied together to determine how well they work in combination and to find the safest and most effective doses for treating patients whose multiple myeloma has returned or become resistant to other treatments.

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancer cells produce large amounts of abnormal proteins instead of useful antibodies. The disease typically affects the bones of the spine, skull, pelvis, rib cage, and the areas around the shoulders and hips. As the disease progresses, it can interfere with the production of normal blood cells in the bone marrow and can weaken the bones.

Trial ID:

2024-512146-41-00

Protocol code:

M24-555

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of etentamig and iberdomide treatment for patients with relapsed or refractory multiple myeloma

What is this study about?

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