Study comparing iberdomide, daratumumab and dexamethasone versus daratumumab, bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma
This study focuses on patients with Multiple Myeloma, a type of blood cancer that has either not responded to previous treatment or has returned after treatment (known as relapsed or refractory). The study compares two different combination treatments. The first combination includes Iberdomide (also known as CC-220), Daratumumab, and Dexamethasone. The second combination consists of Daratumumab, Bortezomib, and Dexamethasone.
The purpose of this study is to determine which treatment combination works better in treating patients with relapsed or refractory Multiple Myeloma. The medications are given in different ways – some are taken by mouth as tablets or capsules, while others are given through injection under the skin or into a vein. The treatment will continue as long as it remains beneficial for the patient and side effects are manageable.
During the study, doctors will monitor how well the treatments work by checking the amount of cancer cells in the blood and bone marrow. They will also track how long patients live without their disease getting worse and evaluate the overall survival of patients receiving these treatments. Throughout the study, patients will have regular check-ups to monitor their health and any side effects from the treatments.
1Initial assessment
Your eligibility for the study will be confirmed based on your multiple myeloma diagnosis and previous treatments
You must have received 1-2 prior treatments for multiple myeloma
You must have shown improvement with at least one previous treatment
Your current physical condition will be evaluated using the ECOG performance status scale
2Treatment assignment
You will be randomly assigned to one of two treatment groups:
Group 1: IberDd – Iberdomide (capsules taken by mouth) + Daratumumab (injection under the skin) + Dexamethasone (tablets taken by mouth)
Group 2: DVd – Daratumumab (injection under the skin) + Bortezomib (tablets taken by mouth) + Dexamethasone (tablets taken by mouth)
3Treatment period
Regular assessments will monitor your response to treatment
Blood samples will be taken to measure the level of disease markers
Bone marrow samples will be collected to check for remaining cancer cells
Your overall health and any side effects will be monitored throughout the treatment
4Follow-up period
Your health will continue to be monitored after completing treatment
Regular checks will track if the disease returns or progresses
Quality of life assessments will be conducted using questionnaires
The study will continue until September 2028
5Safety requirements
You must follow specific pregnancy prevention measures throughout the study
Blood donation is not permitted during treatment and for 28 days after
Regular pregnancy testing is required for individuals who can become pregnant
Additional safety measures will be explained based on your assigned treatment group
Who Can Join the Study?
Must be at least 18 years old
Must have been diagnosed with Multiple Myeloma with measurable disease levels
Must have received one to two previous treatments for multiple myeloma
Must have shown positive response (improvement) to at least one previous treatment
Must have evidence that the disease has progressed during or after the last treatment
Must have a performance status score of 0, 1, or 2 (measure of patient’s ability to perform daily activities)
Must be willing and able to follow the study schedule and requirements
Must sign an informed consent form before any study procedures
For those who can become pregnant:
Must have two negative pregnancy tests
Must agree to ongoing pregnancy testing
Must use two forms of birth control or practice abstinence
For male participants:
Must use contraception or practice abstinence during the study and for specified time after
Must not donate sperm during the study and for specified time after
Must not donate blood during the study and for 28 days after treatment ends
Must follow all requirements of the Pregnancy Prevention Program
If previously treated with certain medications (CD38-directed therapy):
Must have shown positive response to that treatment
Must not have had disease progression within 60 days of last dose
Must have stopped treatment at least 3 months before joining study
Who Cannot Join the Study?
Prior treatment with iberdomide (an experimental drug for multiple myeloma)
Active central nervous system involvement of multiple myeloma
Known allergy or sensitivity to any of the study medications
Previous stem cell transplant within 12 weeks before starting the study
Significant heart conditions including heart failure or recent heart attack (within 6 months)
Active or chronic liver disease
Other types of cancer requiring treatment (except for successfully treated skin cancer or cervical cancer)
Uncontrolled high blood pressure
Serious infections requiring treatment
Pregnancy or breastfeeding
Unable to take blood-thinning medications
Major surgery within 2 weeks before starting the study
Peripheral neuropathy (nerve damage causing numbness or tingling) grade 2 or higher
Participation in other clinical trials within 28 days before this study
Mental conditions that could interfere with following study procedures
Iberdomide (also known as BMS-986382) is a medication being studied for treating relapsed or refractory multiple myeloma. It belongs to a new class of drugs that helps the immune system fight cancer cells.
Daratumumab is an antibody medication that targets specific proteins on myeloma cells. It works by helping the body’s immune system recognize and destroy cancer cells in multiple myeloma.
Dexamethasone is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In multiple myeloma treatment, it is often combined with other medications to enhance their effectiveness.
Bortezomib is a targeted therapy that belongs to a class of drugs called proteasome inhibitors. It works by blocking certain proteins that help cancer cells survive, causing the cancer cells to die.
Multiple Myeloma – A blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. These abnormal cells produce large amounts of defective antibodies that build up in the body. The disease typically affects multiple bones in the body, hence its name. Over time, the condition can damage bones, lead to high blood calcium levels, and cause problems with blood cell production. The disease often progresses through cycles of active disease and remission.
Relapsed Multiple Myeloma – A form of multiple myeloma that has returned after a period of remission or response to previous treatment. The disease shows signs of progression after a period when it was under control.
Refractory Multiple Myeloma – A form of multiple myeloma that does not respond to current therapy, or stops responding during treatment. The disease continues to progress despite ongoing treatment efforts.
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