RecruitingRare disease

Study of ciltacabtagene autoleucel in patients with newly diagnosed multiple myeloma using a modified treatment preparation regimen

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Newly Diagnosed Multiple Myeloma, a type of blood cancer that develops in plasma cells found in bone marrow. The research evaluates a treatment called ciltacabtagene autoleucel (also known as cilta-cel), which is a specialized therapy that uses a patient's own modified immune cells to fight cancer cells.

The treatment involves collecting the patient's own T cells (a type of immune cell), which are then genetically modified in a laboratory to recognize and attack cancer cells. These modified cells are later given back to the patient through an intravenous infusion. The purpose of this study is to evaluate how well this treatment works when given with a modified preparation regimen that excludes a specific medication called fludarabine.

During the study, patients will receive their modified immune cells as a single infusion. The cells are stored in special freezing bags and will be thawed before being given to the patient. The treatment is part of a category of therapies known as cell therapy, which represents an advanced form of cancer treatment where the patient's own immune system is enhanced to fight the disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial qualification
The qualification process verifies if you meet specific requirements, including:
- Age between 18 and 80 years
- Diagnosed with newly diagnosed multiple myeloma
- Not a candidate for high-dose chemotherapy with stem cell transplantation
- Must have received and responded positively to initial treatment with VRd or DRd therapy
- Physical ability score (ECOG) of 0 or 1, indicating good daily activity level
- Required laboratory test results within specified ranges
Step 2
Treatment preparation
Your treatment will involve ciltacabtagene autoleucel, also known as CARVYKTI
The medication is prepared as a personalized cell therapy
The preparation includes a special conditioning treatment plan without the medication fludarabine
Step 3
Treatment administration
The medication will be administered through intravenous infusion (directly into your vein)
The dose contains between 3.2 × 10^6 and 1 × 10^8 cells
The infusion is given as a single treatment
Step 4
Follow-up period
Regular monitoring will continue for at least 12 months after treatment
The main assessment will occur at the 12-month mark to check for complete response to treatment
The study will continue until December 2028

Who can join the trial?

9 criteria

Must be between 18 and 80 years old when providing consent to participate in the study
Must have a confirmed diagnosis of newly diagnosed multiple myeloma (a type of blood cancer affecting plasma cells) with measurable disease before starting any treatment
Cannot be a candidate for high-dose chemotherapy with stem cell transplantation due to one of these reasons:
- Advanced age
- Having other medical conditions that could affect tolerance to the treatment
- Personal decision to refuse this type of treatment
- Must have received initial treatment with either VRd or DRd (combinations of anti-myeloma medications) and achieved at least a partial response (improvement in disease symptoms) to this treatment
- Must have an ECOG Performance Status score of 0 or 1 (meaning able to carry out all or most daily activities without assistance)
- Must meet specific laboratory test requirements as defined in the study protocol
- Both men and women can participate in the study

Who cannot join the trial?

14 criteria

Prior treatment with any therapy for multiple myeloma (except for emergency use of short-term steroids)
Age below 18 years or above 80 years
Previous or current participation in other clinical trials within 30 days before starting this study
History of other cancers within the past 3 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
Significant heart problems, including heart failure (weakening of the heart muscle) or uncontrolled heart rhythm problems
Active or chronic hepatitis B or C infection (liver infections)
Known HIV infection (human immunodeficiency virus)
Active or uncontrolled infections requiring treatment
Significant kidney problems requiring dialysis
History of stroke or bleeding in the brain within the past 6 months
Mental health conditions that could interfere with study participation
Pregnancy or breastfeeding
Unable to understand or sign the informed consent form
Known allergic reactions to study medications

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Hospital Universitario De Navarra
Verified
Pamplona, Spain

Trial locations

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Investigated drugs

Ciltacabtagene autoleucel
(cilta-cel) is a type of personalized cell therapy where a patient's own immune cells (T-cells) are modified in a laboratory to recognize and fight multiple myeloma cancer cells. The modified cells are then infused back into the patient's body to help fight the cancer.
Fludarabine
is a chemotherapy medication typically used to prepare the body before cell therapy. In this trial, researchers are studying how the treatment works without using fludarabine in the preparation regimen.

Ciltacabtagene Autoleucel

What is already known about the treatment

Ciltacabtagene autoleucel - A specialized cell therapy administered through intravenous infusion, consisting of genetically modified T cells designed to target specific proteins on cancer cells in multiple myeloma patients. This innovative CAR T-cell therapy is currently being investigated in clinical trials for newly diagnosed multiple myeloma, representing a promising advancement in immunotherapy treatments. The medication works by reprogramming the patient's own immune cells to recognize and attack cancer cells expressing the BCMA protein, which is commonly found on myeloma cells, while the modified administration protocol explores a fludarabine-free lymphodepletion regimen to potentially reduce side effects.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. These cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. The disease causes these abnormal cells to produce large amounts of a single type of antibody, while suppressing the production of normal antibodies. Multiple myeloma often affects multiple bones in the body, leading to bone weakening. The condition typically develops gradually, starting from a precancerous state called monoclonal gammopathy of undetermined significance (MGUS). As the disease progresses, it can cause various complications in the body's normal blood cell production and bone structure.