Study on Isatuximab, Carfilzomib, and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma

2 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer known as relapsed and/or refractory multiple myeloma. This condition occurs when multiple myeloma, a cancer of the plasma cells in the bone marrow, returns after treatment or does not respond to treatment. The study is investigating a treatment combination that includes isatuximab, carfilzomib, and dexamethasone. Isatuximab, also known by its code name SAR650984, is given as a solution for injection under the skin. Carfilzomib is administered as a solution for infusion into a vein, and dexamethasone is provided in tablet form or as an injection.

The purpose of the study is to evaluate the effectiveness of this combination treatment. Participants will receive the treatment over a period of time, and their response to the treatment will be monitored. The study will also look at how participants feel about the treatment method, particularly the use of a special device called the On Body Delivery System (OBDS) for administering isatuximab. This device is a single-use, wearable system that delivers the medication under the skin.

Throughout the study, researchers will observe various aspects of the treatment, such as the overall response rate, any side effects, and the duration of the response. The study aims to provide valuable information on how well this treatment combination works for people with relapsed and/or refractory multiple myeloma, and how it affects their quality of life. Participants’ experiences and satisfaction with the treatment will also be assessed through questionnaires. The study is expected to continue until December 2026.

1 joining the study

Upon joining the study, a diagnosis of multiple myeloma is confirmed. Eligibility is based on specific criteria, including previous treatments and measurable disease markers.

2 treatment initiation

The treatment involves a combination of medications: isatuximab, carfilzomib, and dexamethasone.

Isatuximab is administered subcutaneously, which means it is injected under the skin.

Carfilzomib is given intravenously, meaning it is delivered directly into a vein.

Dexamethasone is taken orally in tablet form.

3 treatment schedule

The treatment is organized in cycles. Each cycle lasts for a specific period, during which the medications are administered according to a set schedule.

The frequency and dosage of each medication are determined by the study protocol and may vary based on individual response and tolerance.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment. This includes blood tests, imaging studies, and other evaluations as required.

The primary goal is to evaluate the overall response rate to the treatment combination.

5 completion of treatment

The study is expected to continue until December 2026. Participation may end earlier based on individual circumstances or study findings.

Upon completion, final assessments are conducted to evaluate the overall effectiveness and any long-term effects of the treatment.

Who Can Join the Study?

Participants must have a documented diagnosis of multiple myeloma (MM), which is a type of cancer.
Participants must have a measurable disease, which means they need to have certain levels of specific proteins in their blood or urine. This includes:
- Serum M-protein of at least 0.5 grams per deciliter (g/dL), measured using a test called serum protein immunoelectrophoresis.
- Urine M-protein of at least 200 milligrams per 24 hours, measured using a test called urine protein immunoelectrophoresis.
- Serum free light chain (FLC) assay: Involved FLC assay of at least 10 milligrams per deciliter (mg/dL) and an abnormal serum FLC ratio, which is less than 0.26 or more than 1.65.
Participants must have relapsed and/or refractory MM, meaning the disease has returned or is not responding to treatment, with at least one prior line of therapy and no more than three prior lines of therapy.
Female participants must not be pregnant or breastfeeding. If they are of childbearing potential, they must agree to practice complete abstinence or use approved contraception methods.
Male participants must agree to practice true abstinence or use approved contraception methods while receiving study treatment, during dose interruptions, and for at least five months after stopping the study treatment, even if they have had a successful vasectomy.
Participants must be capable of giving signed informed consent, which means they understand the study and agree to participate.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not experienced a return or worsening of their multiple myeloma after treatment.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications.
Patients who have had a recent infection that requires treatment.
Patients who have received certain treatments for their cancer recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Evangelismos S.A.	Athens	Greece
Alexandra Hospital	Athens	Greece
Fakultni Nemocnice Brno	Brno	Czechia
Champalimaud Clinical Centre	Lisbon	Portugal
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
University Hospital Ostrava	Ostrava	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	07.06.2023
Greece	Not recruiting	07.06.2023
Portugal	Not recruiting	07.06.2023

Trial locations

Investigated drugs:

Isatuximab is a medication used in this trial to treat multiple myeloma, a type of blood cancer. It is administered under the skin (subcutaneously) and works by targeting and binding to a specific protein on the surface of cancer cells, helping the immune system to destroy them.

Carfilzomib is another medication used in the trial for treating multiple myeloma. It is a type of drug known as a proteasome inhibitor, which helps to stop the growth of cancer cells by interfering with their ability to break down proteins.

Dexamethasone is a steroid medication included in the trial. It is used to reduce inflammation and suppress the immune system, which can help enhance the effectiveness of other cancer treatments and manage symptoms associated with multiple myeloma.

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 crowd out healthy blood cells, leading to bone damage, anemia, and increased risk of infections. As the disease progresses, it can cause bone pain, fractures, and kidney problems due to the accumulation of abnormal proteins produced by the cancer cells. Relapsed or refractory multiple myeloma refers to the condition when the disease returns after treatment or does not respond to standard therapies. The progression of the disease can vary, with some patients experiencing slow development of symptoms, while others may have a more aggressive course.

Trial ID:

2023-508870-27-00

Protocol code:

ACT17453

NCT ID:

NCT05704049

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Isatuximab, Carfilzomib, and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?