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Study Comparing Iberdomide and Lenalidomide for Maintenance Therapy After Stem Cell Transplant in Patients with Newly Diagnosed 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 clinical trial is focused on studying a disease called Newly Diagnosed Multiple Myeloma (NDMM), which is a type of blood cancer that affects plasma cells in the bone marrow. The study is comparing two treatments: Iberdomide and Lenalidomide. Iberdomide, also known by its code name CC-220, is being tested to see how effective it is compared to Lenalidomide, which is already used for treating NDMM. The purpose of the study is to determine which treatment is more effective in maintaining the health of patients after they have undergone a procedure called Autologous Stem Cell Transplantation (ASCT).

Participants in the study will receive either Iberdomide or Lenalidomide after their ASCT. The study will observe how long patients remain free from disease progression, which means the disease does not get worse. This is known as Progression-Free Survival (PFS). The study will also look at other factors, such as the overall survival of patients, which is the time from starting the treatment until death from any cause. Additionally, the study will monitor the safety of the treatments, including any side effects that may occur.

The trial will take place over a period of time, with regular check-ups to monitor the patients' health and response to the treatment. The study aims to provide valuable information on the best maintenance therapy for patients with NDMM following ASCT, helping to improve treatment strategies for this condition.

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, you will be randomly assigned to one of two groups. One group will receive iberdomide and the other will receive lenalidomide as maintenance therapy after your stem cell transplant.

  2. Step 2

    Medication administration

    If you are in the iberdomide group, you will take the medication orally in capsule form. The dosage will be determined based on the study's requirements.

    If you are in the lenalidomide group, you will also take the medication orally in capsule form. The dosage will be specified according to the study protocol.

  3. Step 3

    Treatment duration

    The maintenance therapy will continue for a period specified by the study, which aims to evaluate the effectiveness of the treatment in prolonging the time without disease progression.

  4. Step 4

    Regular assessments

    Throughout the study, you will undergo regular assessments to monitor your health and the effectiveness of the treatment. These assessments may include blood tests, imaging studies, and other evaluations as required by the study protocol.

  5. Step 5

    End of study participation

    Your participation in the study will conclude at the end of the treatment period or if you experience disease progression or any significant side effects that require discontinuation of the study medication.

Who can join the trial?

9 criteria

  • Participants must have a confirmed diagnosis of Newly Diagnosed Multiple Myeloma (NDMM), which means they have a type of blood cancer that affects plasma cells.
  • At the time of diagnosis, participants should have monoclonal plasma cells in the bone marrow that are 10% or more, or have a biopsy-proven plasmacytoma (a type of tumor).
  • Participants must have experienced at least one myeloma-defining event as per the International Myeloma Working Group (IMWG) criteria.
  • At enrollment, participants should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, which indicates their level of functioning in terms of daily activities.
  • Participants must have received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and an immunomodulatory compound (IMiD), with or without a CD38 monoclonal antibody, or a combination of bortezomib, cyclophosphamide, and dexamethasone, followed by a single or tandem autologous stem cell transplant (ASCT).
  • Participants should be within 12 months from the start of induction therapy and have achieved at least a partial response after ASCT, with or without additional treatment to strengthen the response (consolidation), according to IMWG 2016 criteria.
  • If participants have not received consolidation therapy, they must be within 120 days after the transplant at the time of randomization.
  • If participants have received consolidation therapy, they must be within 30-60 days of the last dose of consolidation therapy at the time of randomization and within 180 days after the transplant at the time of randomization.
  • Participants can be of any gender.

Who cannot join the trial?

6 criteria

  • Patients who have not been diagnosed with Newly Diagnosed Multiple Myeloma (NDMM) cannot participate.
  • Patients who have not undergone Autologous Stem Cell Transplantation (ASCT) are excluded. ASCT is a procedure where a patient's own stem cells are used to replace damaged or diseased bone marrow.
  • Patients who are not within the specified age range for the study are excluded.
  • Patients who are not part of the specified clinical trial group are excluded.
  • Both male and female patients are eligible, but those who do not meet other criteria are excluded.
  • Patients who are considered part of a vulnerable population, such as those unable to give informed consent, may be excluded.
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Investigated drugs

  • Iberdomide

    is a medication being studied for its potential to help people with a type of blood cancer called multiple myeloma. It is being tested to see if it can help keep the cancer from coming back after patients have received a stem cell transplant. Iberdomide works by affecting the immune system and the cancer cells, aiming to slow down or stop the growth of the cancer.

  • Lenalidomide

    is another medication used in the study for patients with multiple myeloma. It is already used in treating this type of cancer and works by helping the immune system attack cancer cells and by stopping the cancer cells from growing. In this trial, it is being used as a comparison to see how well it works against iberdomide in preventing the return of cancer after a stem cell transplant.

What is already known about the treatment

  • Iberdomide

    Iberdomide is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating newly diagnosed multiple myeloma, particularly as a maintenance therapy after autologous stem cell transplantation. The main therapeutic indication for iberdomide is to help prolong the period during which the disease does not worsen. At the molecular level, iberdomide works by modulating the immune system and targeting specific proteins that are involved in the growth and survival of cancer cells. It is classified as an immunomodulatory drug.

  • Lenalidomide

    Lenalidomide is also taken orally in capsule form. It is an established medication in the treatment of multiple myeloma and is widely documented in medical literature. In this context, it is used as a maintenance therapy to help prevent the progression of newly diagnosed multiple myeloma after stem cell transplantation. Lenalidomide functions by enhancing the immune system's ability to fight cancer and by directly attacking cancer cells. It belongs to the class of drugs known as immunomodulatory agents.

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. It begins when a single plasma cell becomes abnormal and multiplies rapidly, leading to the accumulation of these abnormal cells in the bone marrow. As the disease progresses, it can cause bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The abnormal plasma cells produce an excess of a single type of antibody, which can be detected in the blood or urine. Over time, the disease can lead to damage in various organs and tissues, primarily due to the overproduction of these abnormal antibodies and the crowding out of normal blood cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501515-14-00Protocol codeIM048-022Estimated enrolment1 216 patientsSponsorCelgene Corp.

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