Study Comparing Lenalidomide, Bortezomib, Dexamethasone, Isatuximab, and Iberdomide for Newly Diagnosed Multiple Myeloma Patients Eligible for Stem Cell Transplant

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What is this study about?

This clinical trial is focused on studying treatments for newly diagnosed multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The study will explore different treatment combinations to see which is most effective. The treatments being tested include a combination of medications: Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone, as well as a new drug called Iberdomide (also known by its code name CC-220). These medications are used in various combinations to see how well they work in treating the disease.

The purpose of the study is to compare the effectiveness of these treatment combinations in patients who are candidates for a procedure called autologous stem cell transplant (ASCT). This procedure involves collecting a patient’s own stem cells, treating them with high doses of chemotherapy, and then returning the stem cells to the patient to help rebuild their bone marrow. The study will look at how well the treatments work in reducing the number of cancer cells in the bone marrow after 18 cycles of treatment, which includes different phases such as induction, consolidation, and continuous treatment.

Participants in the study will receive one of the treatment combinations and may also receive a placebo as part of the study design. The study will last for a maximum of 24 months, during which time the effectiveness of the treatments will be monitored. The goal is to find out which combination of treatments is most effective in helping patients achieve a state where no cancer cells are detected in their bone marrow, known as being MRD-negative (minimal residual disease-negative). This information will help doctors understand which treatments might be best for patients with newly diagnosed multiple myeloma.

1 induction phase

During the induction phase, you will receive treatment to reduce the number of cancer cells. This phase lasts for 4 to 6 cycles, depending on the treatment arm you are assigned to.

If you are in Arm A or Arm C, you will undergo 4 cycles of treatment. If you are in Arm B, you will undergo 6 cycles.

The medications used in this phase include lenalidomide (oral capsules), bortezomib (subcutaneous injection), and dexamethasone (oral tablets).

2 autologous stem cell transplant (ASCT)

After the induction phase, you will undergo an autologous stem cell transplant (ASCT). This procedure involves collecting your own stem cells, which are then returned to your body after intensive treatment to help restore your bone marrow.

3 consolidation phase

Following the ASCT, you will enter the consolidation phase, which consists of 2 cycles of treatment. This phase aims to further reduce the number of cancer cells.

The same medications used in the induction phase will be administered during this phase.

4 continuous or extended treatment phase

In Arm A and Arm C, you will receive continuous treatment for 12 cycles. In Arm B, you will receive extended treatment for 10 cycles.

The medications used in this phase may include lenalidomide, isatuximab (subcutaneous injection), and iberdomide (oral capsules).

5 early rescue intervention (ERI)

If necessary, you may receive an early rescue intervention (ERI) with iberdomide and isatuximab to help achieve better treatment outcomes.

This intervention is only applied if the treatment response requires additional support before completing the 18 cycles and ASCT.

Who Can Join the Study?

  • The patient must be newly diagnosed with multiple myeloma and need to start treatment.
  • The patient must be willing and able to follow the study requirements, according to the investigator’s opinion.
  • The patient must be able to understand the study procedures.
  • The patient must provide written informed consent before any study-related procedures.
  • The patient must be 65 years old or younger.
  • The patient must have a performance status of 2 or less on the Eastern Cooperative Oncology Group (ECOG) scale, which measures the patient’s ability to perform daily activities.
  • The patient must have adequate organ function as defined in the study protocol.
  • The patient must have a measurable secretory disease, which means having certain levels of specific proteins in the blood or urine.
  • All previous treatment-related side effects must be at a mild level (Grade 1 or less) at the time of joining the study, except for hair loss.
  • Male patients must use contraception according to local regulations for clinical studies.
  • Female patients must use contraception according to local regulations for clinical studies.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with newly-diagnosed multiple myeloma (NDMM) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific health criteria set by the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario De Leon Leon Spain
Hospital Son Llatzer Palma Spain
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Hospital Universitario De Canarias La Laguna Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Hospital General Universitario De Albacete Albacete Spain
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Hxwoltma Ugefcxooflwls Dfmtuwoe Donostia / San Sebastian Spain
Hyvwgeyu Uqjzwcymlcken Ldyfz Asxpqee Lugo Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
09.11.2022

Trial locations

Lenalidomide is a medication used in this trial to help treat multiple myeloma, a type of blood cancer. It works by slowing down or stopping the growth of cancer cells. It also helps the immune system to attack the cancer cells more effectively.

Bortezomib is another medication used in the trial for treating multiple myeloma. It helps to kill cancer cells by interfering with their ability to grow and divide. This medication is often used in combination with other drugs to improve its effectiveness.

Dexamethasone is a type of steroid used in the trial. It helps reduce inflammation and can also help kill cancer cells. In this study, it is used alongside other medications to enhance their cancer-fighting effects.

Isatuximab is a medication used in the trial that targets specific proteins on the surface of cancer cells. By binding to these proteins, it helps the immune system to recognize and destroy the cancer cells more effectively.

Iberdomide is a medication being tested in the trial as part of an early rescue intervention. It is designed to help the immune system work better in fighting cancer cells, potentially improving the outcomes for patients with multiple myeloma.

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. The disease begins when abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, frequent infections, and fatigue. Over time, the accumulation of abnormal cells can lead to anemia and increased risk of fractures. The progression of multiple myeloma can vary, with periods of stability followed by more aggressive phases.

Trial ID:
2024-517008-12-00
Protocol code:
GEM21menos65
Trial Phase:
Therapeutic confirmatory (Phase III)

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