Study on Iberdomide, Cyclophosphamide, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition known as relapsed/refractory multiple myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study is testing a combination of medications to see how well they work together. The medications being used in this study are Iberdomide (also known by its code name CC-220), Cyclophosphamide, and Dexamethasone. Iberdomide is a capsule that has activities that can help regulate the immune system and promote the death of cancer cells. Cyclophosphamide is a tablet that works as an alkylating agent, which means it can interfere with the growth of cancer cells. Dexamethasone is a tablet that is a type of steroid used to reduce inflammation and suppress the immune system.

The purpose of this study is to evaluate how long patients can live without their disease getting worse while taking this combination of medications. Participants in the study will take these medications by mouth in specific doses over a period of time. The study will monitor the participants’ health and response to the treatment, including any side effects they may experience. The study will also look at how well the treatment works in terms of overall response and survival rates.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how the treatment affects their condition. The study aims to provide valuable insights into the effectiveness of this treatment combination for patients with relapsed/refractory multiple myeloma. The results could help improve future treatment options for this challenging condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the study, including the medications involved and their potential side effects.

You will be asked to provide written informed consent, confirming your understanding and willingness to participate in the study.

2 baseline assessments

Before starting the treatment, baseline assessments will be conducted. These assessments may include blood tests, urine tests, and other necessary evaluations to determine your current health status and the extent of your multiple myeloma.

3 treatment initiation

The treatment involves taking three medications: iberdomide, cyclophosphamide, and dexamethasone. All medications are taken orally.

Iberdomide is taken in capsule form. The specific dosage and frequency will be provided by the study team.

Cyclophosphamide is taken as a coated tablet, with the dosage and frequency specified by the study team.

Dexamethasone is taken as a tablet, with the dosage and frequency specified by the study team.

4 ongoing treatment and monitoring

Throughout the study, you will continue taking the medications as directed. Regular monitoring will be conducted to assess your response to the treatment and to check for any side effects.

You will have scheduled visits to the study site for assessments, which may include blood tests, urine tests, and other evaluations.

5 end of treatment

The duration of the treatment will be determined by the study team based on your response and overall health condition.

After completing the treatment, final assessments will be conducted to evaluate the outcomes and any long-term effects.

6 follow-up

After the treatment ends, follow-up visits may be scheduled to monitor your health and gather additional data for the study.

These visits will help in understanding the long-term effects of the treatment and your overall well-being.

Who Can Join the Study?

Must be at least 18 years old.
Must have a WHO performance status of 0, 1, or 2. This is a measure of your ability to carry out daily activities, where 0 means fully active and 2 means you are up and about more than half the day.
Must have a life expectancy of at least 3 months.
If you are a female who can have children, you must have two negative pregnancy tests before starting the study. You must agree to ongoing pregnancy testing and use two forms of birth control or practice complete abstinence from heterosexual contact during the study and for a period after the study ends.
Must provide written informed consent, which means you agree to participate after being fully informed about the study.
If you are a male, you must agree to use a condom during sexual contact with a pregnant female or a female who can have children while participating in the study and for a period after the study ends, even if you have had a vasectomy.
All participants must agree not to donate blood while on the study and for a period after the study ends.
All male participants must agree not to donate sperm while on the study and for a period after the study ends.
Must have a confirmed diagnosis of multiple myeloma with measurable disease, which means certain levels of specific proteins in your blood or urine.
Must have relapsed or refractory disease. Relapsed means the disease returned after responding to treatment. Refractory means the disease did not respond well to treatment.
Must have had 2-4 prior treatments for multiple myeloma. Previous treatment with a drug called pomalidomide is allowed.
Must have developed lenalidomide-refractory disease, meaning the disease did not respond to or progressed during or shortly after treatment with lenalidomide.

Who Cannot Join the Study?

Patients who have not been diagnosed with relapsed/refractory multiple myeloma cannot participate. This means the study is only for those whose multiple myeloma has returned after treatment or did not respond to treatment.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is for a specific group of patients with certain characteristics.
Patients who are not willing to follow the study procedures and requirements cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, may not be eligible unless specific conditions are met.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Amphia Hospital	Breda	The Netherlands
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Rldhpbujx Zlmfhuvqqi Sccrcpock	Arnhem	The Netherlands
Uskzomvkcnqm Membfzd Cizezaq Gkktmphjy	Groningen	The Netherlands
Awtrbcsmj Ury	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.05.2020

Trial locations

Investigated drugs:

Iberdomide is a medication being studied for its potential to help treat multiple myeloma, a type of blood cancer. It works by affecting the immune system and targeting cancer cells, which may help slow down or stop the growth of the cancer.

Cyclophosphamide is a chemotherapy drug used to treat various types of cancer, including multiple myeloma. It works by damaging the DNA of cancer cells, which can prevent them from growing and dividing. This helps to reduce the number of cancer cells in the body.

Dexamethasone is a type of steroid medication that is often used in cancer treatment. It helps reduce inflammation and can also help kill cancer cells. In the context of multiple myeloma, it is used to enhance the effects of other cancer treatments and help manage symptoms.

Relapsed/Refractory 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 relapsed or refractory cases, the disease has returned after treatment or does not respond to therapy. The disease progresses as abnormal plasma cells multiply uncontrollably, leading to bone damage, kidney problems, and weakened immune function. Patients may experience 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 the disease can vary, with periods of stability followed by worsening symptoms.

Trial ID:

2023-508902-66-00

Protocol code:

HAEM-2020-1

NCT ID:

NCT04392037

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Iberdomide, Cyclophosphamide, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?