Study on Dexamethasone for Patients with Advanced Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying Multiple Myeloma, a type of cancer that affects certain cells in the bone marrow. The study is investigating the use of Dexamethasone, a medication that can be taken as an oral solution, tablet, or through injection, as an initial treatment for patients with advanced stages of this disease. The purpose of the study is to determine how well patients respond to this treatment after several cycles.

Participants in the study will receive Dexamethasone in one of its available forms, and their progress will be monitored over a period of time. The study aims to see if the treatment can help achieve a significant response in patients, which means either a complete or partial reduction of the disease symptoms. The study is designed to compare the effectiveness of Dexamethasone with other treatment options available for Multiple Myeloma.

The trial will involve several cycles of treatment, and the response of the patients will be assessed using specific criteria set by experts in the field. This study is important for understanding how Dexamethasone can be used effectively in treating Multiple Myeloma and may provide valuable insights into improving treatment strategies for this condition.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient must provide signed informed consent to participate.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying a diagnosis of multiple myeloma in relapse and ensuring the patient has received between 1 to 3 prior therapies for multiple myeloma.

3 treatment regimen

The patient will receive a free regimen of dexamethasone as initial therapy. Dexamethasone can be administered orally, intramuscularly, or intravenously, depending on the specific treatment plan.

4 treatment cycles

The treatment consists of six cycles of salvage therapy. The patient’s response to the treatment will be assessed using the International Myeloma Working Group criteria.

5 response evaluation

The primary goal is to determine the overall response rate after six cycles. This includes evaluating the proportion of patients who achieve a complete or partial response.

6 completion of trial

The trial is estimated to end by June 30, 2028. The patient’s participation will conclude after the final assessment of their response to the treatment.

Who Can Join the Study?

  • Must be an adult, which means you need to be at least 18 years old.
  • Must have a confirmed diagnosis of Multiple Myeloma that has come back after treatment. Multiple Myeloma is a type of cancer that affects certain blood cells in the bone marrow.
  • Must have received between 1 to 3 previous treatments for Multiple Myeloma. A treatment counts if it included at least 2 cycles of therapy.
  • Must be eligible for one of the following approved treatment combinations:
    • ICARIA schema: includes the drugs isatuximab, pomalidomide, and dexamethasone.
    • IKEMA schema: includes the drugs isatuximab, carfilzomib, and dexamethasone.
  • Must have shown improvement (at least a partial response) to the last treatment received.
  • Must have an ECOG Performance Status score of 0, 1, or 2. This score is a way to measure how well you can perform daily activities. A score of 0 means fully active, 1 means some symptoms but still able to do light work, and 2 means unable to work but can take care of yourself.
  • If you had side effects from previous treatments, they must be resolved or stable. This includes issues like peripheral neuropathy, which is a condition that causes numbness or tingling in the hands and feet.
  • Must provide a signed informed consent, which means you agree to participate in the study after being informed about all the details.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Multiple Myeloma. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

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 Lille Lille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hopital Saint Antoine Paris France
Centre Hospitalier Blois Simone Veil Blois France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Les Hopitaux De Chartres Le Coudray France
Centre Hospitalier William Morey Chalon Sur Saone France
Chorale Du Centre Hospitalier De Lens Lens France
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Aix En Provence France
Centre Hospitalier De Niort Niort France
Centre Hospitalier D Avignon Avignon France
Centre Henri Becquerel Rouen France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier De Perigueux Perigueux France
Groupe Hospitalier Bretagne Sud Lorient France
Centre Hospitalier Intercommunal Compiegne Noyon Compiegne France
Centre Hospitalier De Saint-Quentin Saint Quentin France
Centre Hospitalier Bretagne Atlantique Vannes France
Institut De Cancerologie De Bourgogne Dijon France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
L’Hopital Prive Du Confluent Nantes France
L’Hopital Alexandra Lepeve Dunkirk France
Direction Centrale Du Service De Sante Des Armees Toulon France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Centre Hospital Region Metz Thionville Metz 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
Recruiting
11.12.2024

Trial locations

Investigated drugs:

Dexamethasone is a medication used in this trial as an initial therapy for patients with advanced relapsed or refractory multiple myeloma. It is a type of corticosteroid that helps reduce inflammation and suppresses the immune system, which can be beneficial in treating certain types of cancer, including multiple myeloma. In this study, it is being used to evaluate its effectiveness in improving the overall response rate in patients undergoing salvage therapy.

Investigated diseases:

Multiple Myeloma – Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, and anemia due to the disruption of normal blood cell production. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses slowly, but it can become more aggressive over time.

Trial ID:
2024-510981-18-00
Protocol code:
APHP231089
NCT ID:
NCT06561854
Trial Phase:
Therapeutic confirmatory (Phase III)

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