RecruitingRare disease

Study of mezigdomide and elranatamab combination treatment for patients with relapsed or refractory multiple myeloma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Relapsed or Refractory Multiple Myeloma, a type of blood cancer that has either returned after treatment or did not respond well to previous treatments. The study will test a combination of two medications: mezigdomide (also known as CC-92480) given as oral capsules, and elranatamab given through an intravenous infusion. Dexamethasone, a commonly used steroid medication, will also be part of the treatment.

The main purpose of this research is to determine the safest and most effective dose of mezigdomide when used together with elranatamab, and to understand how well this combination works in treating the disease. The study will look at how participants respond to the treatment and monitor any side effects that may occur.

During the study, participants will receive the combination treatment and undergo regular medical check-ups. Doctors will track how well the treatment is working by measuring the amount of cancer in the body and monitoring the participants' overall health. They will also look at how long the treatment keeps working and how it affects participants' survival.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive a combination of medications: mezigdomide in capsule form taken by mouth, and elranatamab given through an intravenous infusion (through a vein).
A third medication, dexamethasone, will be taken orally as part of your treatment regimen.
The initial phase requires hospitalization to monitor your response to the treatment.
Step 2
Monitoring and evaluation
Your disease status will be regularly measured through blood tests to assess the treatment's effectiveness.
You will need to undergo bone marrow examinations at specific times during the treatment.
Your overall health status will be monitored throughout the treatment period.
Step 3
Response assessment
Your response to the treatment will be evaluated through regular medical examinations.
The medical team will assess if the treatment is working by measuring the amount of cancer cells in your body.
Laboratory tests will be conducted to check for any remaining disease using sensitive detection methods.
Step 4
Ongoing treatment
Treatment will continue as long as you are responding positively and not experiencing significant side effects.
Regular evaluations will determine if the treatment should be adjusted or continued.
The study will monitor how long the treatment remains effective and your overall health status.
Step 5
End of treatment evaluation
A final bone marrow examination will be performed to assess your disease status.
Complete medical evaluation will be conducted to document your response to the treatment.
Long-term follow-up may be required to monitor your health status after completing the treatment.

Who can join the trial?

8 criteria

Must sign a written informed consent form to participate in the study
Must have Relapsed or Refractory Multiple Myeloma (RRMM) and have received between 2 to 4 previous treatments for myeloma
Must have measurable disease that can be monitored through laboratory tests
Must agree to required hospital stays during the study
Must consent to bone marrow tests (samples taken from inside the bone) during screening, treatment, and at the end of treatment
Must have an ECOG Performance Status of 0 or 1 (able to carry out all normal activities or restricted in physically strenuous activities but able to walk and do light work)
Must be an adult (18 years or older)
Can be either male or female

Who cannot join the trial?

15 criteria

Age below 18 years
Previous participation in clinical trials with Mezigdomide or Elranatamab treatments
Known allergic reactions to similar medications
Pregnant or breastfeeding women
Active or untreated infections
Major surgery within 4 weeks before starting the study
Serious heart conditions or uncontrolled high blood pressure
Significant liver problems (liver disease)
Significant kidney problems (kidney disease)
Active other types of cancer
History of bleeding disorders
Mental conditions that could interfere with following study procedures
Use of any other experimental drugs within 30 days before starting the study
Unable to swallow oral medications
Any condition that study doctors believe would make participation unsafe

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Alexandra Hospital
Athens, Greece
Verified
EVAGGELISMOS"General Hospital of Athens
Athens, Greece
Verified
Hospital Universitario De Salamanca
Salamanca, Spain

Trial locations

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Investigated drugs

Mezigdomide
is a medication being studied for the treatment of multiple myeloma, a type of blood cancer. It belongs to a class of drugs that help modify the immune system's response to cancer cells. This medication is being tested as part of a combination therapy for patients whose multiple myeloma has either returned after previous treatment or hasn't responded well to other treatments.
Elranatamab
is a targeted therapy medication that works by helping the body's immune system fight multiple myeloma cells. It is designed to recognize and attach to specific proteins found on cancer cells, potentially helping to destroy them. This medication is being studied in combination with Mezigdomide to potentially improve outcomes for patients with resistant or recurring multiple myeloma.

What is already known about the treatment

Mezigdomide
An investigational oral medication being studied for the treatment of relapsed or refractory multiple myeloma (RRMM). This drug is currently in Phase 1b/2a clinical trials, being tested in combination with Elranatamab to determine its optimal dosing and safety profile. The medication belongs to a new class of therapeutic agents targeting multiple myeloma, with ongoing research to establish its effectiveness and proper dosing schedule.
Elranatamab
An investigational biologic medication administered through injection for treating relapsed or refractory multiple myeloma (RRMM). This drug is being evaluated in clinical trials in combination with Mezigdomide to assess its safety and effectiveness in patients who have not responded to or have relapsed after previous treatments. The medication is designed to target specific proteins involved in multiple myeloma progression, representing a novel approach to treating this form of blood cancer.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infection. In this condition, cancerous plasma cells accumulate in the bone marrow, crowding out healthy blood cells and producing abnormal proteins. The disease typically affects multiple areas of the body, particularly the bones, leading to their weakening. As it progresses, it can cause various complications including anemia, frequent infections, and bone problems. The disease can enter periods of remission and relapse, where symptoms may improve or worsen over time.