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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
St. Olavs Hospital HF Trondheim Norway
Alexandra Hospital Athens Greece
Unblrjvyjp Mlihgzn Csstap Houmwbejzxhgargic Hamburg Germany
Hasxxvmh Ukhmqwnumszva Mrewxva Dw Vdrjqauxwe Santander Spain
Epuxntvpbiucylfaqsbzgpxytu Hwqkupij oj Anbmwj Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
15.09.2025
Greece Greece
Not yet recruiting
15.09.2025
Norway Norway
Not yet recruiting
15.09.2025
Spain Spain
Recruiting
15.09.2025

Trial locations

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.

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.

Trial ID:
2025-522090-11-00
Protocol code:
CA057-1040
Trial Phase:
Human Pharmacology (Phase I) – Other

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