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Study of Ciltacabtagene Autoleucel and Drug Combination for Treatment of High-Risk Smoldering Multiple Myeloma

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 High-risk Smoldering Multiple Myeloma, which is an early form of blood cancer that may progress to active multiple myeloma. The main treatment being tested is Ciltacabtagene Autoleucel, a type of cell therapy where a patient's own immune cells are modified in a laboratory to fight cancer cells. Before receiving this treatment, patients will receive a combination of other medications including Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone.

Additional medications used in the study include Fludarabine and Cyclophosphamide, which are given to prepare the body for the cell therapy. The purpose of this research is to determine how well this treatment combination works and how safe it is for patients with high-risk smoldering multiple myeloma. The treatment involves receiving chemotherapy medications through infusions into veins or as injections under the skin, as well as taking some medications by mouth.

The study will monitor patients for several years after treatment to check how well the therapy works and to watch for any side effects. Doctors will regularly examine the bone marrow to look for any remaining cancer cells and will track how long patients remain free from disease progression. Blood tests will be performed regularly to monitor the patient's immune system and overall health.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive a combination of medications known as Dara-VRD, which includes:

    - Daratumumab given as an injection under the skin

    - Bortezomib given as an injection under the skin

    - Lenalidomide taken by mouth

    - Dexamethasone taken by mouth

  2. Step 2

    Cell collection procedure

    Your blood cells will be collected through a procedure called apheresis

    These cells will be used to create your personalized treatment

  3. Step 3

    Preparation treatment

    You will receive medications to prepare your body for the cell therapy:

    - Fludarabine given through an intravenous line

    - Cyclophosphamide given through an intravenous line

  4. Step 4

    Cell therapy administration

    You will receive ciltacabtagene autoleucel (cilta-cel), which are your modified cells

    The cells will be given through an intravenous infusion

    The dose will be between 3.2 × 10^6 and 1 × 10^8 cells

  5. Step 5

    Follow-up period

    Your progress will be monitored for up to 5 years after receiving the cell therapy

    Regular tests will be performed to check your response to treatment

    Blood and bone marrow samples will be collected to monitor your condition

Who can join the trial?

17 criteria

  • Must be at least 18 years of age or legally able to consent
  • Must have high-risk smoldering multiple myeloma meeting specific medical criteria, including certain protein levels in blood and bone marrow
  • Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
  • Must have adequate kidney function (filtration rate of at least 40 mL/min)
  • Must have acceptable liver function and blood test results, including:
    • Adequate hemoglobin levels (at least 8.0 g/dL)
    • Sufficient white blood cell counts
    • Adequate platelet levels (at least 75,000 per microliter)
    • Must be either HIV-negative or have controlled HIV disease if positive
    • For women who can become pregnant:
      • Must have negative pregnancy test
      • Must use effective birth control during study and 6 months after
      • Must not donate eggs during study and 6 months after treatment
      • For men:
        • Must use contraception during study and for 1 year after treatment
        • Must not donate sperm during study and for 1 year after treatment
        • Must not plan to father children during study and for 1 year after
        • Must sign informed consent forms
        • Must be willing to follow study requirements and restrictions
        • Must not be participating in other clinical trials

Who cannot join the trial?

15 criteria

  • Prior treatment with any anti-myeloma therapy (including daratumumab or any other monoclonal antibodies)
  • History of plasma cell leukemia (a condition where abnormal plasma cells are found in the blood)
  • Active or prior malignancy (cancer) within 3 years before starting the study
  • Known allergies or severe reactions to study medications
  • Significant heart conditions, including:
    • Heart failure with reduced heart function
    • Uncontrolled irregular heartbeat
    • Heart attack within the past 6 months
    • Severe kidney problems (creatinine clearance less than 30 mL/min)
    • Active or chronic liver disease
    • Active, uncontrolled infections including:
      • HIV infection
      • Active hepatitis B or hepatitis C
      • Pregnant or breastfeeding women
      • Unable to take blood-thinning medications
      • Participation in another clinical trial within 30 days before this study
      • Any condition that, in the opinion of the study doctor, would interfere with safe participation in the study
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Investigated drugs

  • Ciltacabtagene autoleucel (cilta-cel)

    is a type of CAR T-cell therapy, which means it uses your own modified immune cells to fight cancer. This treatment involves collecting your T-cells (a type of white blood cell), modifying them in a laboratory to recognize and attack cancer cells, and then returning them to your body to fight the disease. This therapy is specifically designed to target multiple myeloma cells.

  • Daratumumab (Dara)

    is an antibody medication that works by helping your immune system fight certain cancer cells. It attaches to a specific protein on cancer cells, making it easier for your immune system to identify and destroy them.

  • VRD

    is a combination therapy that includes three medications working together: - Bortezomib (Velcade) is a targeted therapy that blocks certain proteins to stop cancer cells from growing - Lenalidomide (Revlimid) is a medication that helps your immune system fight cancer cells and can also block blood supply to tumors - Dexamethasone is a steroid medication that helps reduce inflammation and can make other cancer treatments more effective

What is already known about the treatment

  • Ciltacabtagene autoleucel (cilta-cel)

    A cell therapy administered through intravenous infusion that belongs to the class of CAR T-cell therapies used in treating multiple myeloma. This innovative treatment involves modifying a patient's own T-cells in a laboratory to recognize and attack cancer cells, specifically targeting BCMA (B-cell maturation antigen) on myeloma cells. Currently undergoing clinical trials for high-risk smoldering multiple myeloma, this therapy represents a promising advancement in immunotherapy approaches for early intervention in myeloma progression.

  • Daratumumab (Dara)

    An injectable monoclonal antibody that targets the CD38 protein found on multiple myeloma cells. Used in combination therapy (as part of VRD regimen) for treating multiple myeloma, this medication works by helping the immune system identify and destroy cancer cells while also having direct anti-tumor effects. The drug is administered intravenously or subcutaneously and has shown significant efficacy in various stages of multiple myeloma treatment, including newly diagnosed cases.

Investigated diseases

Multiple Myeloma (Smoldering) - A precursor condition to multiple myeloma where abnormal plasma cells accumulate in the bone marrow but haven't yet caused symptoms or organ damage. In this early stage, the body produces abnormal proteins (M proteins) that can be detected in blood tests, but the condition hasn't progressed to cause bone damage, kidney problems, or other complications. The high-risk form shows certain characteristics that suggest a higher likelihood of progression to active multiple myeloma. The condition is monitored through regular blood tests and bone marrow examinations to track protein levels and plasma cell counts.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510560-12-00Protocol codeGEM-CAR-HiRiSMMEstimated enrolment20 patientsSponsorFundacion PETHEMA

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