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

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What is this study about?

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.

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

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

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

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 Study?

  • 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 Study?

  • 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

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
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hecsulod Utsrfngotqvep Mfzcxch Dj Vtyhbfofqv Santander Spain
Hbrfcsid Uebigjdpuehmv Hmdnojsv Tmqqg y Pvgktx Imsofsrv Cssbww dlbizpbfxcugzcsze (hqkl Badalona Spain
Hkiujgcr Vbha dmnrazcj Barcelona Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.09.2025

Trial locations

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.

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.

Trial ID:
2025-521975-30-00
Protocol code:
68284528MMY2012
Trial Phase:
Therapeutic exploratory (Phase II)

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