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Study Comparing Bortezomib, Lenalidomide, and Dexamethasone with Ciltacabtagene Autoleucel for Newly Diagnosed Multiple Myeloma Patients Not Planning Stem Cell Transplant

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 clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects the blood. The study will explore the effectiveness of different treatment combinations. One group of participants will receive a combination of medications: Bortezomib, Lenalidomide, and Dexamethasone, followed by a special therapy called Ciltacabtagene Autoleucel, which is a type of CAR-T cell therapy. CAR-T cell therapy is a treatment where a patient's own immune cells are modified to better fight cancer. The other group will receive the same initial combination of Bortezomib, Lenalidomide, and Dexamethasone, followed by continued treatment with Lenalidomide and Dexamethasone.

The purpose of this study is to compare how well these treatment plans work in terms of how long patients live without their disease getting worse, which is known as progression-free survival. Participants in the study will be randomly assigned to one of the two treatment groups. The study will involve taking medications in the form of tablets or capsules, and some treatments will be given through an infusion, which means the medicine is delivered directly into the bloodstream through a vein.

Throughout the study, participants will be monitored regularly to assess their health and the effectiveness of the treatments. The study aims to provide valuable information on the best treatment approach for people with newly diagnosed Multiple Myeloma who are not planning to undergo a stem cell transplant as their initial therapy. The trial will continue for several years to gather comprehensive data on the long-term effects and benefits of the treatments being tested.

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

    The initial treatment phase involves the administration of a combination of medications: bortezomib, lenalidomide, and dexamethasone. This combination is referred to as VRd therapy.

    Bortezomib is administered as a subcutaneous injection. Lenalidomide and dexamethasone are taken orally in the form of capsules and tablets, respectively.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of two treatment groups after the initial VRd therapy.

    One group receives a single administration of ciltacabtagene autoleucel, a type of CAR-T cell therapy, which is given as an intravenous infusion.

    The other group continues with maintenance therapy using lenalidomide and dexamethasone, taken orally.

  3. Step 3

    Maintenance therapy

    For participants in the lenalidomide and dexamethasone group, maintenance therapy involves ongoing oral administration of these medications.

    The dosage and frequency of lenalidomide and dexamethasone are determined by the study protocol and adjusted based on individual response and tolerance.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

    Participants undergo routine medical evaluations, including blood tests and imaging studies, to track the progression of multiple myeloma.

  5. Step 5

    End of trial

    The trial is estimated to conclude in June 2034. At the end of the trial, data will be analyzed to determine the efficacy of the treatments in terms of progression-free survival.

    Participants will receive information about their treatment outcomes and any further steps if necessary.

Who can join the trial?

9 criteria

  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of Multiple Myeloma, which is a type of blood cancer.
  • Must have a measurable disease at the time of screening, meaning the disease can be measured or tracked by doctors.
  • Must not be considered for high-dose chemotherapy with autologous stem cell transplant (ASCT), which is a procedure where a patient's own stem cells are used to replace damaged or destroyed bone marrow.
  • Must have an Eastern Cooperative Oncology Group Performance Status grade of 0 or 1, which means the person is fully active or has some symptoms but can carry out light work.
  • If a woman can have children, she must have two negative pregnancy tests before starting the study and agree to more tests during the study.
  • If a woman can have children, she must agree to either not have heterosexual intercourse or use two reliable birth control methods at the same time.
  • If a man is sexually active with a woman who can have children or is pregnant, he must agree to use a barrier method of contraception, like a condom, from the time of signing the consent form until a specified time after the last dose of certain study drugs.
  • Both women and men must agree not to donate eggs or sperm during the study and for a specified time after the last dose of certain study drugs.

Who cannot join the trial?

10 criteria

  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients who have a serious infection that is not under control.
  • Patients who have a history of heart problems, such as a heart attack or heart failure.
  • Patients who have a condition called **neuropathy**, which means they have nerve damage that causes numbness or tingling, especially if it is severe.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had an organ transplant.
  • Patients who are taking part in another clinical trial.
  • Patients who have a known allergy to any of the study drugs.
  • Patients who have a condition called **autoimmune disease**, where the body's immune system attacks its own cells.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

Bortezomib is a medication used in the treatment of multiple myeloma. It works by interfering with the growth of cancer cells, slowing their spread in the body. In this trial, it is part of the initial treatment combination. Lenalidomide is another medication used to treat multiple myeloma. It helps the immune system attack cancer cells and also reduces the growth of new blood vessels that tumors need to grow. It is used both in the initial treatment and as part of the maintenance therapy. Dexamethasone is a type of steroid that helps reduce inflammation and is used to treat multiple myeloma. It is included in both the initial treatment and maintenance therapy in this trial. Ciltacabtagene Autoleucel is a type of CAR-T cell therapy. This treatment involves modifying a patient's own T cells to better recognize and attack cancer cells. It is used after the initial treatment in one of the study groups to help control the disease. In this trial, the combination of these medications and therapies is being studied to determine the best approach for treating newly diagnosed multiple myeloma in patients who are not planning to undergo a stem cell transplant.

What is already known about the treatment

  • Bortezomib

    Bortezomib is administered via injection, typically under the skin or into a vein. It is currently well-established in medical literature as a treatment for multiple myeloma. The main therapeutic indication for bortezomib is to treat multiple myeloma by inhibiting proteasomes, which are enzyme complexes that break down proteins in cells, thereby disrupting cancer cell growth. It is classified as a proteasome inhibitor.

  • Lenalidomide

    Lenalidomide is taken orally in capsule form. It is widely recognized in medical literature for its use in treating multiple myeloma. The primary therapeutic indication is to treat multiple myeloma by modulating the immune system and inhibiting the growth of cancer cells. It belongs to the class of immunomodulatory drugs.

  • Dexamethasone

    Dexamethasone is administered orally or by injection. It is a well-known medication in medical literature, used for its anti-inflammatory and immunosuppressant properties. In the context of multiple myeloma, it helps reduce inflammation and suppress the immune response to aid in cancer treatment. It is classified as a corticosteroid.

  • Ciltacabtagene Autoleucel

    Ciltacabtagene autoleucel is administered as a single infusion. It is a newer therapy in medical literature, specifically for multiple myeloma, involving CAR-T cell therapy that targets the BCMA protein on myeloma cells. This therapy works by modifying a patient's T cells to better recognize and attack cancer cells. It is classified as a CAR-T cell therapy.

Investigated diseases

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 accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause symptoms such as bone pain, fatigue, and frequent infections due to weakened immune function. The abnormal plasma cells can also produce a protein that can damage the kidneys and other organs. Over time, the disease can lead to complications like anemia, kidney problems, and increased risk of fractures.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505850-16-00Protocol code68284528MMY3004Estimated enrolment621 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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