Study Comparing Isatuximab with Carfilzomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Eligible for Stem Cell Transplant

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What is this study about?

This clinical trial is focused on studying a blood cancer called multiple myeloma, which affects plasma cells in the bone marrow. The study is comparing two treatment combinations for patients who have been newly diagnosed with multiple myeloma and are eligible for a procedure called autologous stem cell transplantation. The first treatment combination includes four medications: Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone. The second combination includes Carfilzomib, Lenalidomide, and Dexamethasone without Isatuximab. The purpose of the study is to see which combination is more effective in treating the disease.

Participants in the study will receive one of the two treatment combinations. The study will last for a period of up to 24 months. During this time, participants will have regular check-ups and tests to monitor their health and the effectiveness of the treatment. The study aims to find out how well the treatments work in reducing the amount of cancer cells in the body, which is known as achieving minimal residual disease negativity. This means that the number of cancer cells is so low that they cannot be detected using standard tests.

The study will also look at other important factors, such as the overall survival of participants, the time it takes for the disease to progress, and the quality of life of the participants. By comparing these two treatment combinations, researchers hope to find the best approach for treating newly diagnosed multiple myeloma in patients who are eligible for stem cell transplantation. The study is expected to continue until April 2030.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. Written consent is required before any study-specific activities begin.

2 induction phase

During this phase, the patient will receive a combination of medications to treat multiple myeloma. The medications include isatuximab (administered intravenously), carfilzomib (administered intravenously), lenalidomide (administered orally in capsule form), and dexamethasone (administered orally as a solution).

The specific dosages and frequency of administration will be determined by the healthcare provider based on the patient’s condition and response to treatment.

3 autologous stem cell transplantation (ASCT)

Following the induction phase, the patient will undergo an autologous stem cell transplantation. This procedure involves collecting the patient’s own stem cells, which are then reintroduced into the body after high-dose chemotherapy.

4 post-ASCT consolidation treatment

After the transplantation, the patient will receive consolidation treatment to eliminate any remaining cancer cells. This phase includes the same combination of medications as the induction phase: isatuximab, carfilzomib, lenalidomide, and dexamethasone.

5 light consolidation phase

In this phase, the patient continues to receive treatment with the goal of maintaining remission. The medications used are similar to those in previous phases, with adjustments made as necessary based on the patient’s response.

6 monitoring and follow-up

Throughout the trial, the patient’s health and response to treatment will be closely monitored. Regular assessments will be conducted to evaluate the effectiveness of the treatment and to check for any side effects.

Who Can Join the Study?

The patient must have been newly diagnosed with multiple myeloma, a type of blood cancer.
The patient should be eligible for autologous stem cell transplantation (ASCT), a procedure where a patient’s own stem cells are used to replace damaged or diseased bone marrow.
The patient must be between 18 and 70 years old.
The patient should have monoclonal plasma cells in the bone marrow that are 10% or more, or have a biopsy-proven plasmacytoma (a type of tumor) and meet certain criteria related to calcium, kidney function, anemia, or bone damage.
The patient must have a measurable disease, which means certain levels of specific proteins in the blood or urine that can be tracked.
The patient should have a life expectancy of at least 3 months.
The patient must have an ECOG status of 2 or less, which is a scale used to assess how a disease affects a patient’s daily living abilities.
The patient must have certain clinical laboratory values within specific ranges, such as liver function tests, blood cell counts, and kidney function.
Females of childbearing potential must follow a Pregnancy Prevention Plan, which includes using effective birth control methods and undergoing regular pregnancy tests.
Male patients must agree to use contraception if sexually active with females of childbearing potential and refrain from donating sperm for a specified period after treatment.
The patient must be willing and able to attend study visits and follow the procedures required by the study.
The patient must provide written informed consent, which means they agree to participate in the study after being informed about its details.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with multiple myeloma cannot participate. 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 cannot participate. The age range is typically defined by the study organizers.
Patients who are not part of the specified clinical trial group cannot participate. This group is determined by the study organizers based on specific criteria.
Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes individuals who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Frisius	Heerenveen	The Netherlands
Hospital Universitario De Salamanca	Salamanca	Spain
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Amphia Hospital	Breda	The Netherlands
St. Olavs Hospital HF	Trondheim	Norway
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Gasthuiszusters Antwerpen	Antwerp	Belgium
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Universita Degli Studi Di Brescia	Brescia	Italy
University Hospital Ostrava	Ostrava	Czechia
University Hospital Consorziale Policlinico	Bari	Italy
Uezpaylpyj Mbhxrby Ceeqqu Hcvzfrecemzdqwfva	Hamburg	Germany
Uyftijbrjsdh Metqncl Ctygump Ggcivncqo	Groningen	The Netherlands
Hzemvrkv Uqbvthdryoykl Mbulksu Dh Vxzyzizzjn	Santander	Spain
Txkbiemdnp Cavwjs Hounozbj	Thessaloniki	Greece
Ayqrmixyk Uut	Amsterdam	The Netherlands
Ewfsiuy Uhbhqwxauxfg Mkznxyr Cysvytn Rfsxmbkcr (vdpfpgq Mzn	Rotterdam	The Netherlands
Ayutifh Oiwgrkntpao Uveagkslmlbwl Cjykxkyxjwow Dgrrt Svwgja E Debhn Snmjvfr Dl Twmvfa	Turin	Italy
Aowmmnv Uspzu Smpmbokfl Lryics Dx Bewtpub	Bologna	Italy
Hazqofnr Uwxmrmikkfrhv Holuufrn Tkmwf y Pawgbv Ithmnocn Caarsg dwybcbujrzhzhhyzs (jcay	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.07.2020
Czechia	Not recruiting	01.07.2020
Germany	Not recruiting	01.07.2020
Greece	Not recruiting	01.07.2020
Italy	Not recruiting	01.07.2020
Norway	Not recruiting	01.07.2020
Spain	Not recruiting	01.07.2020
The Netherlands	Not recruiting	01.07.2020

Trial locations

Investigated drugs:

Isatuximab is a medication used in the treatment of multiple myeloma. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells.

Carfilzomib is a medication that helps treat multiple myeloma by blocking certain proteins in cancer cells, which leads to their death. It is often used in combination with other medications to enhance its effectiveness.

Lenalidomide is a medication that modifies the immune system and has anti-cancer effects. It is used to treat multiple myeloma by slowing the growth of cancer cells and helping the immune system attack them.

Dexamethasone is a type of steroid that reduces inflammation and is used in combination with other medications to treat multiple myeloma. It helps enhance the effects of other cancer treatments and manage symptoms.

Multiple Myeloma – Multiple myeloma is a type of blood 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 crowd out healthy blood cells, leading to symptoms such as bone pain, frequent infections, and anemia. As the disease progresses, it can cause damage to bones and kidneys, and lead to high levels of calcium in the blood. The abnormal plasma cells produce a protein that can be detected in the blood or urine, which helps in monitoring the disease. Over time, multiple myeloma can lead to complications such as weakened bones, kidney problems, and increased risk of infections. The progression of the disease varies among individuals, with some experiencing slow progression and others more rapid advancement.

Trial ID:

2024-513422-38-00

Protocol code:

EMN24

NCT ID:

NCT04483739

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Isatuximab with Carfilzomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Eligible for Stem Cell Transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?