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.
1joining 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.
2medication 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.
3treatment 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.
4regular 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.
5end 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 Study?
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 Study?
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.
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.
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.
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