Study on the Long-Term Safety of Isatuximab for Adults with Multiple Myeloma Benefiting from Isatuximab Therapy

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment called isatuximab for patients with multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is designed for patients who have previously participated in earlier phases of research involving isatuximab and have experienced benefits from the treatment. The main goal is to continue monitoring the safety of isatuximab when used alone or in combination with other treatments.

Participants in this study will continue to receive isatuximab as they did in their previous study. The treatment will be administered either as a single therapy or alongside other medications, depending on what was used in the earlier study. The study will track any new side effects or health issues that arise during the treatment period. This will help researchers understand the long-term effects of isatuximab and ensure it remains safe for patients who continue to benefit from it.

The study will last for several years, allowing researchers to gather comprehensive data on the safety of isatuximab over an extended period. This information is crucial for determining the best ways to use isatuximab in treating multiple myeloma and ensuring that patients receive the most effective and safe care possible. Participants will be closely monitored by their healthcare providers throughout the study to ensure their well-being and to address any concerns that may arise during the treatment.

1 joining the study

Upon joining the study, the participant must be at least 18 years old and have completed a previous study involving isatuximab.

The participant should still be receiving isatuximab and benefiting from it, as determined by the treating physician.

2 treatment administration

The study involves the administration of isatuximab, either alone or in combination with other medications.

The medication isatuximab is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

3 monitoring and safety assessment

Throughout the study, the safety of isatuximab will be monitored closely.

Participants will be observed for any adverse effects that may arise from the treatment.

4 completion of the study

The study is expected to continue until January 21, 2027.

Participants will remain in the study as long as they continue to benefit from the treatment and meet the necessary criteria.

Who Can Join the Study?

  • The participant must be at least 18 years old, or the legal age of consent in the area where the study is happening, when they sign the consent form.
  • The participant must have been part of a previous Phase 1, 2, or 3 study that tested isatuximab alone or with other treatments, and all the study goals must have been completed.
  • The participant must still be receiving isatuximab when the previous study ends, and they must be benefiting from it, either alone or with other treatments, as decided by their doctor. They must also meet the requirements to start another round of treatment as described in the previous study. If they are not receiving isatuximab at the end of the previous study and cannot get the treatment locally, they may still be included.
  • Participants must use two methods of birth control if they are male or female. Female participants must not be pregnant or breastfeeding. Male participants must not donate sperm.
  • The participant must be able to give signed consent, meaning they understand and agree to take part in the study.

Who Cannot Join the Study?

  • Patients who have not been previously treated with isatuximab. Isatuximab is a type of medication used in cancer treatment.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients with certain medical conditions that might interfere with the study or make participation unsafe.
  • Patients who are pregnant or breastfeeding, as the study may involve risks to the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients with severe health issues that could affect their ability to participate safely.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Region Norrbotten Lulea Sweden
Evangelismos S.A. Athens Greece
Virgen del Rocío University Hospital Sevilla Spain
Alexandra Hospital Athens Greece
Fakultni Nemocnice Brno Brno Czechia
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Ostrava Ostrava Czechia
Hozxzegg Unoccawylkbxx Mwtyeve Dg Vugwrreipo Santander Spain
Hlvlnphb Uqpfmqkfus Cgtnhzd Hmpkvldc Helsinki Finland
Ajyjpdm Ovcgueiuwrr Urfzweatzupuq Clyuzxnqwwtl Dphyg Ssldmm E Dluja Sjivpmm Dy Tgmfro Turin Italy
Iyzcpnce Cstucx Dgvphrkqsihxndktv L'hospitalet De Llobregat Spain

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
05.04.2023
Finland Finland
Not recruiting
05.04.2023
France France
Not recruiting
05.04.2023
Greece Greece
Not recruiting
05.04.2023
Italy Italy
Not recruiting
05.04.2023
Spain Spain
Not recruiting
05.04.2023
Sweden Sweden
Not recruiting
05.04.2023

Trial locations

Isatuximab is a medication used in the treatment of multiple myeloma, a type of blood cancer. It works by targeting and binding to a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. In this clinical trial, isatuximab is being studied to evaluate its long-term safety when used alone or in combination with other treatments for patients who have previously benefited from it in earlier studies.

Investigated diseases:

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. These cells can invade nearby tissues and form tumors, which may disrupt normal bodily functions. As cancer progresses, it can metastasize, meaning it spreads to other parts of the body through the blood or lymphatic system. The progression of cancer varies depending on the type and location of the cancer, as well as individual factors. Some cancers grow slowly and may not cause symptoms for a long time, while others can be aggressive and rapidly affect health. Understanding the specific type of cancer is crucial for determining its behavior and potential impact on the body.

Trial ID:
2023-507180-19-00
Protocol code:
LTS17704
Trial Phase:
Therapeutic exploratory (Phase II)

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