Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study Comparing Idecabtagene Vicleucel and Lenalidomide Maintenance Therapy for Adults with Newly Diagnosed Multiple Myeloma After Stem Cell Transplant

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the treatment of Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves adult participants who have been newly diagnosed with this condition and have not responded optimally after undergoing a procedure called Autologous Stem Cell Transplantation (ASCT). The trial aims to compare the effectiveness and safety of a new treatment called Idecabtagene Vicleucel (also known as bb2121) combined with Lenalidomide maintenance therapy, against Lenalidomide maintenance therapy alone. Lenalidomide is a medication that helps to slow down or stop the growth of cancer cells, while Idecabtagene Vicleucel is a type of cell therapy that uses modified immune cells to target and destroy cancer cells.

Participants in the study will receive either the combination of Idecabtagene Vicleucel and Lenalidomide or Lenalidomide alone. The study will monitor the participants over a period to assess how well the treatments work in preventing the progression of the disease, which is referred to as Progression Free Survival (PFS). The trial will also look at other outcomes such as overall survival, the duration of response to the treatment, and any side effects experienced by the participants. The study is designed to provide valuable information on whether the combination therapy offers better outcomes compared to Lenalidomide alone.

The trial will involve regular check-ups and assessments to monitor the participants' health and response to the treatment. Participants will receive the treatments through different methods, such as oral capsules for Lenalidomide and intravenous infusions for Idecabtagene Vicleucel. The study is expected to continue for several years to gather comprehensive data on the long-term effects and benefits of the treatments. This research is crucial in finding more effective ways to manage and treat Multiple Myeloma, especially for those who do not achieve the desired response from standard treatments.

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

    Joining the study

    Upon joining the study, the participant is confirmed to have a newly diagnosed condition known as multiple myeloma with a suboptimal response after a procedure called autologous stem cell transplantation.

  2. Step 2

    Initial treatment phase

    The participant receives a combination of medications including lenalidomide in the form of hard capsules, taken orally. The dosage may vary between 2.5 mg, 5 mg, 10 mg, and 15 mg depending on the specific treatment plan.

    Other medications administered include cyclophosphamide monohydrate and fludarabine phosphate, both given through intravenous infusion. These medications are used to prepare the body for the main treatment.

  3. Step 3

    Main treatment phase

    The main treatment involves the administration of idecabtagene vicleucel, a specialized therapy given through intravenous infusion. This is a key part of the study aimed at improving the participant's condition.

    Supportive medications such as diphenhydramine hydrochloride and paracetamol may be given orally to manage any side effects and ensure comfort during the treatment.

  4. Step 4

    Maintenance therapy

    Following the main treatment, the participant continues with lenalidomide maintenance therapy. This involves taking the medication in capsule form orally, with the dosage adjusted as needed to maintain the participant's health and prevent disease progression.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, the participant's health is closely monitored. Regular assessments are conducted to evaluate the effectiveness of the treatment and to check for any adverse effects.

    The study aims to measure outcomes such as progression-free survival and other health indicators to determine the success of the treatment.

Who can join the trial?

8 criteria

  • Participants must be **18 years or older** with **Newly Diagnosed Multiple Myeloma** who have received treatment including high-dose chemotherapy and **autologous stem cell transplantation** (a procedure where a patient's own stem cells are used to replace damaged or destroyed bone marrow).
  • Participants should not have received further treatment after the stem cell transplantation, except for a short period (7 days or less) of **lenalidomide** (a medication used to treat multiple myeloma) if it does not affect the overall benefit or risk.
  • Participants must have completed **4 to 6 cycles of initial therapy** that includes at least an **immunomodulatory drug** (a drug that helps regulate the immune system) and a **proteasome inhibitor** (a drug that blocks the action of proteasomes, which are protein complexes that break down proteins) and possibly an **anti-CD38 monoclonal antibody** (a type of drug that targets specific proteins on cancer cells). They must have had a single stem cell transplant 80 to 120 days before joining the study.
  • Participants must not have shown confirmed progression of the disease since starting the initial therapy.
  • Participants must have a documented response of **Partial Response (PR)** or **Very Good Partial Response (VGPR)** at the time of joining the study. These terms refer to the level of improvement in the disease.
  • Participants must have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 1 or less. This is a scale used to assess how a disease affects a patient's daily living abilities. A score of 1 means the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature.
  • Participants with an ECOG score of 2 due to pain from myeloma-related bone lesions may still be eligible if the investigator agrees.
  • Participants must have recovered to a level of 1 or less for any non-blood-related side effects from previous treatments, except for hair loss and moderate nerve damage.

Who cannot join the trial?

6 criteria

  • Patients who have not been diagnosed with Newly Diagnosed Multiple Myeloma with a suboptimal response after an Autologous Stem Cell Transplantation. This means the patient must have this specific type of blood cancer and have had a transplant using their own stem cells, but the treatment did not work as well as expected.
  • Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study may involve medications that could affect the baby.
  • Patients who are participating in another clinical trial at the same time, as this could affect the results of the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Idecabtagene Vicleucel

    is a type of therapy that uses genetically modified cells to target and destroy cancer cells. It is specifically designed to treat multiple myeloma, a type of blood cancer. This therapy involves collecting a patient's own immune cells, modifying them in a laboratory to better recognize and attack cancer cells, and then infusing them back into the patient.

  • Lenalidomide

    is a medication used to treat multiple myeloma. It works by helping the immune system attack cancer cells and by stopping the growth of new blood vessels that tumors need to grow. In this trial, Lenalidomide is used as a maintenance therapy to help prevent the cancer from returning after initial treatment.

What is already known about the treatment

  • Idecabtagene Vicleucel

    This medication is administered through an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating newly diagnosed multiple myeloma in patients who have had a suboptimal response after autologous stem cell transplantation. The main therapeutic indication is to improve progression-free survival in these patients. At the molecular level, it works by modifying a patient's own T-cells to target and destroy cancer cells. It is classified as a CAR T-cell therapy.

  • Lenalidomide

    This medication is taken orally in the form of capsules. It is well-established in medical literature and is used as a maintenance therapy for multiple myeloma, particularly after stem cell transplantation. The main therapeutic indication is to prolong progression-free survival in patients with multiple myeloma. Its mechanism of action involves modulating the immune system and inhibiting the growth of cancer cells. It is classified as an immunomodulatory drug.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply uncontrollably, leading to bone damage, kidney problems, and a weakened immune system. The disease often progresses slowly, with symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of these abnormal cells can cause anemia and other blood-related issues. The progression of Multiple Myeloma can vary, with periods of stability followed by more aggressive phases. It is considered a chronic condition that requires ongoing monitoring and management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501346-30-00Protocol codeCA089-1043Estimated enrolment681 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.