Study of ixazomib, iberdomide and dexamethasone combination in elderly patients with first relapse of multiple myeloma

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What is this study about?

This study focuses on patients with Multiple Myeloma, a type of blood cancer affecting plasma cells in the bone marrow. The research evaluates a combination treatment using three medications: Iberdomide, Ixazomib, and Dexamethasone. These medications are taken orally in the form of tablets or capsules. The study specifically looks at elderly patients whose disease has returned after their first treatment.

The treatment combines different doses of Iberdomide (ranging from 0.75 mg to 1.6 mg daily), Ixazomib (up to 3 mg daily), and Dexamethasone (up to 20 mg daily). The purpose of this research is to determine how well patients respond to this combination of medications, particularly in achieving a very good partial response or better to the treatment.

The study will monitor how the medications work together, how well patients tolerate them, and track any side effects that may occur. Patients will be followed for several years to assess both the short-term and long-term effects of the treatment. The study will also look at how long the treatment remains effective and how it affects patients’ quality of life.

1 Initial treatment phase

You will receive a combination of three medications: Iberdomide, Ixazomib, and Dexamethasone. All medications are taken by mouth.

The medications come in the following forms:

– Iberdomide: capsules (available in 0.75mg, 1mg, 1.3mg, or 1.6mg doses)

– Ixazomib: capsules

– Dexamethasone: tablets

2 Response monitoring at 3 months

Your response to treatment will be evaluated after 3 months of therapy

The evaluation includes checking how well the multiple myeloma is responding to the treatment

3 Response monitoring at 6 months

Another evaluation of your response to treatment will be performed after 6 months of therapy

This assessment will determine how the disease is responding to the medication combination

4 Ongoing assessments

Regular monitoring of side effects throughout the treatment period

Quality of life assessments using specific questionnaires

Blood tests to monitor your condition

The treatment will continue until either the disease progresses or you experience unacceptable side effects

5 Follow-up period

After completing or stopping treatment, you will be monitored to track your progress

The total study duration is planned until June 2028

Who Can Join the Study?

  • Must be 70 years of age or older
  • Must have a general health status score (ECOG) of 2 or less, which means being able to care for yourself and be up and about more than 50% of waking hours
  • Must have a life expectancy of more than 6 months
  • Must provide written informed consent to participate in the study
  • Must have symptomatic multiple myeloma that has returned after first treatment (first relapse)
  • Must have received at least 3 cycles of one previous treatment
  • Must have measurable disease levels shown by at least one of these tests:
    • Blood protein level of 0.5 g/dL or higher
    • Urine protein level of 200 mg or more in 24 hours
    • Free light chain level of 10 mg/dL or higher with abnormal ratio
  • Must meet specific blood test requirements:
    • Adequate white blood cell count (neutrophils)
    • Adequate platelet count
    • Acceptable liver function tests
    • Adequate kidney function
  • Must follow the study’s pregnancy prevention plan
  • For women: must be post-menopausal for at least 24 months or surgically unable to have children
  • For men: must agree to practice complete abstinence or use condoms during treatment and for 90 days after the last dose

Who Cannot Join the Study?

  • Previous severe allergic reactions to any of the study medications (Iberdomide, Ixazomib, or Dexamethasone)
  • Active or uncontrolled infections that require treatment
  • Pregnancy or breastfeeding
  • Major surgery within 14 days before starting the study
  • Participation in another clinical trial within 28 days before starting this study
  • Serious heart conditions, including:
    • Heart attack within the last 6 months
    • Unstable heart rhythm problems
    • Heart failure with symptoms
  • Severe liver problems
  • Severe kidney problems requiring dialysis (a process to filter blood when kidneys don’t work properly)
  • Other types of cancer that require treatment (except for certain skin cancers)
  • Mental health conditions that could interfere with following study procedures
  • Any condition that, in the doctor’s opinion, would make participation unsafe
  • Unable to take oral medications
  • Known HIV, active hepatitis B, or active hepatitis C infection

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Caujar Hpcvctscnav Ufzklhcnfklsm Dx Dtjlz Dijon France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
14.12.2021

Trial locations

Iberdomide is a medication that works by helping to regulate the immune system and fight cancer cells. It belongs to a class of drugs called immunomodulators, which are commonly used in the treatment of multiple myeloma.

Ixazomib is an oral medication that belongs to a group of drugs called proteasome inhibitors. It works by blocking certain proteins in cancer cells, which helps to slow or stop the growth of these cells. It is specifically designed to treat multiple myeloma.

Dexamethasone is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In cancer treatment, it is often used in combination with other medications to enhance their effectiveness and manage certain side effects of treatment.

Multiple myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. These abnormal plasma cells accumulate in the bone marrow, where they interfere with the production of normal blood cells. The disease typically affects multiple areas of the body, particularly the bones, leading to the formation of tumors within the bone marrow. As the condition progresses, it can cause bone pain, weakness, fatigue, and make bones more susceptible to fractures. Multiple myeloma also often leads to decreased kidney function and a reduction in healthy blood cells.

Trial ID:
2024-516257-44-00
Protocol code:
RC21_0169 IFM2021-03
NCT ID:
NCT04998786
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

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  • A study testing etentamig alone or with drug combinations in adult patients with multiple myeloma to assess safety and changes in disease activity

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