Study on the Effects of Isatuximab with Bortezomib, Lenalidomide, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

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What is this study about?

This clinical trial is focused on studying the treatment of Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is investigating the effectiveness of a combination of medications, including Isatuximab (also known by its code name SAR650984), Bortezomib (Velcade®), Lenalidomide, and Dexamethasone. These medications are being tested together to see if they can improve the condition of patients who have been newly diagnosed with multiple myeloma and are not eligible for a transplant.

The purpose of the study is to determine if adding Isatuximab to the existing treatment of Bortezomib, Lenalidomide, and Dexamethasone can help prolong the time patients live without their disease getting worse, known as progression-free survival. Participants in the study will receive either the combination of all four medications or just the three medications without Isatuximab. Some participants may receive a placebo instead of Isatuximab. The study will last for a period of up to 115 weeks, during which the effects of the treatment will be closely monitored.

Throughout the study, participants will take the medications orally or through injections, depending on the specific drug. The study aims to gather information on how well the treatment works and any side effects that may occur. The results will help determine the potential benefits of this new combination therapy for patients with multiple myeloma who cannot undergo a transplant.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of multiple myeloma and ensuring the patient is not eligible for transplant due to age or other health conditions.

2 treatment phase

The treatment phase involves administering a combination of medications. These include isatuximab, bortezomib, lenalidomide, and dexamethasone.

Isatuximab is given through an intravenous infusion. Bortezomib is administered via subcutaneous injection. Lenalidomide is taken orally in the form of hard capsules, with varying dosages such as 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Dexamethasone is available as a tablet or an injection solution.

3 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the patient’s response to treatment. This includes tracking progression-free survival and other health indicators.

Patient-reported outcomes are also collected to evaluate quality of life during the trial.

4 completion and evaluation

Upon completion of the treatment phase, a final evaluation is performed to determine the overall response to the therapy.

The study aims to measure the benefit of adding isatuximab to the treatment regimen in terms of prolonging progression-free survival compared to the standard treatment without it.

Who Can Join the Study?

  • The patient must have a type of cancer called multiple myeloma. This is a cancer that affects certain cells in the bone marrow.
  • The patient should have been newly diagnosed with multiple myeloma and not be eligible for a transplant. This could be because they are 65 years or older, or if they are younger than 65, they have other health issues that make a transplant not possible.
  • There must be evidence of measurable disease. This means that doctors can measure the cancer in some way to see how it responds to treatment.
  • The patient must provide written informed consent. This means they agree to participate in the study after being fully informed about what it involves.
  • Both male and female patients can participate.

Who Cannot Join the Study?

  • Patients who have any other type of cancer besides the one being studied.
  • Patients who are eligible for a transplant. A transplant is a medical procedure where an organ or tissue is moved from one body to another or from one part of the body to another.
  • Patients who are not within the specified age range for the study. The age range is the specific ages that are allowed to participate in the study.
  • Patients who are part of a vulnerable population. This means groups of people who might need special protection or care, such as children, pregnant women, or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital General Universitario Morales Meseguer Murcia Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Fakultni Nemocnice Plzen Plzen Czechia
Evangelismos S.A. Athens Greece
Odense University Hospital Odense Denmark
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Alexandra Hospital Athens Greece
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Universita’ Politecnica Delle Marche Ancona Italy
Aalborg University Hospital Aalborg Denmark
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Centre Hospitalier Lyon Sud Pierre Benite France
Universita Degli Studi Di Brescia Brescia Italy
Centre Hospitalier Universitaire De Caen Normandie Caen France
University Hospital Ostrava Ostrava Czechia
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Cuopkg Hvkgntzhcce Ubvsgsxbemqbz Dz Dxrhm Dijon France
Adheyj Uxcytglvxe Hieaadrq Aarhus Denmark
Ayluqgp Ogpwlgibiui Upcvcrsrwjjrz Ccbwhekgbkvd Dshst Saiiiu E Denui Sjbahym Dv Tizuta Turin Italy
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Gpftrh Uqclhckigi Fnzznwvrr Frankfurt Germany
Apgxjen Uwcyz Synsihdty Lwvala Dw Bsnldwl Bologna Italy
Uqftcmpgzwmioq Cvobxkn Kiibunxmw Gdansk Poland
Hjetmlfu Dl Lw Soofw Chga I Sysj Pix Barcelona Spain
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Caifph Hdccgvltha E Uagkiaapavhpn Dv Cglszmq Ebqccn Coimbra Portugal

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
07.12.2017
Denmark Denmark
Not recruiting
07.12.2017
France France
Not recruiting
07.12.2017
Germany Germany
Not recruiting
07.12.2017
Greece Greece
Not recruiting
07.12.2017
Italy Italy
Not recruiting
07.12.2017
Lithuania Lithuania
Not recruiting
07.12.2017
Poland Poland
Not recruiting
07.12.2017
Portugal Portugal
Not recruiting
07.12.2017
Spain Spain
Not recruiting
07.12.2017
Sweden Sweden
Not recruiting
07.12.2017

Trial locations

Isatuximab is a medication being studied for its potential to help treat multiple myeloma, a type of blood cancer. It is used in combination with other medications to see if it can improve the time patients live without their disease getting worse.

Bortezomib is a medication used to treat multiple myeloma. It works by interfering with the growth of cancer cells, which are eventually destroyed. It is part of the standard treatment regimen for this type of cancer.

Lenalidomide is another medication used in the treatment of multiple myeloma. It helps the immune system attack cancer cells and also prevents the growth of new blood vessels that tumors need to grow.

Dexamethasone is a type of steroid that is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma, it helps enhance the effects of other cancer treatments.

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, anemia, kidney dysfunction, and increased susceptibility to infections. The abnormal plasma cells produce a protein known as monoclonal protein or M protein, which can be detected in the blood or urine. Over time, the accumulation of these proteins can lead to organ damage, particularly affecting the kidneys. The progression of multiple myeloma is typically characterized by periods of stability followed by relapses.

Trial ID:
2024-514417-34-00
Protocol code:
EFC12522
Trial Phase:
Therapeutic confirmatory (Phase III)

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