Study of iberdomide alone or with drug combinations for patients with multiple myeloma: testing safety and effectiveness of different doses

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What is this study about?

This clinical trial studies Multiple Myeloma, a type of blood cancer affecting plasma cells in the bone marrow. The study evaluates a new drug called iberdomide (also known as CC-220) both alone and in combination with other established treatments including dexamethasone and daratumumab. The purpose is to determine the highest safe dose of iberdomide and to assess how well it works in treating patients whose cancer has returned or did not respond to previous treatments.

The treatment involves taking iberdomide capsules by mouth, either alone or together with other medications. Some participants will receive dexamethasone tablets orally, while others may also receive daratumumab as an injection under the skin. The study has multiple parts to test different drug combinations and doses.

The researchers will monitor how patients respond to the treatment by measuring changes in their cancer, tracking side effects, and studying how the body processes the medication. They will also look at how long the treatment keeps the cancer under control and how long patients survive after starting treatment. The study is expected to continue until early 2028.

1 Initial Treatment Phase

You will receive iberdomide in capsule form, taken by mouth daily

Treatment will be given in combination with dexamethasone tablets, also taken by mouth

Some patients will additionally receive daratumumab as an injection under the skin

2 Monitoring Period

Regular assessments will track your response to treatment

Blood tests will be performed to measure the levels of medications in your system

Your multiple myeloma status will be evaluated using standard medical tests

3 Response Evaluation

Your response to treatment will be measured according to standard criteria for multiple myeloma

The effectiveness of the treatment will be assessed through regular medical examinations

The time between starting treatment and seeing initial results will be tracked

4 Long-term Follow-up

Your progress will be monitored until February 2028

Regular assessments will continue to track your health status

Any side effects will be documented throughout the treatment period

5 Safety Monitoring

Side effects will be monitored and documented throughout the study

The severity and frequency of any health changes will be recorded

Your overall health status will be regularly assessed

Who Can Join the Study?

Must be 18 years or older at the time of signing the informed consent form
Must have an ECOG performance status of 0, 1, or 2 (a measure of a patient’s ability to perform daily activities)
Must have a confirmed diagnosis of Multiple Myeloma with measurable disease levels:
– Blood protein level of at least 0.5 g/dL, or
– Urine protein level of at least 200 mg/24 hours, or
– Light chain levels of at least 10 mg/dL with abnormal blood protein ratios
Must have received at least 2 prior treatment regimens for myeloma (for most study groups) or at least 3 prior treatments for specific groups
Must have previously received at least 2 cycles of treatment with:
– Lenalidomide or pomalidomide
– A proteasome inhibitor
– A CD38 antibody (for certain study groups)
Must show disease progression within 60 days from the last treatment
Must agree to follow all requirements of the Pregnancy Prevention Program
Must not donate blood during treatment and for 28 days after the last dose
Male participants must not donate sperm during treatment and for 90 days after the last dose
Must be willing to follow the study schedule and requirements
Must sign an informed consent form before starting any study procedures

Who Cannot Join the Study?

Prior treatment with CC-220 (an experimental drug for multiple myeloma)
Known allergic reactions or hypersensitivity to any components of the study medications
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Other types of cancer within the past 3 years (except for successfully treated skin cancer or early-stage cancer)
Significant heart problems, including heart failure or recent heart attack
Severe liver problems or abnormal liver function tests
Severe kidney problems or requiring dialysis
Blood clotting disorders or history of blood clots
Pregnancy or breastfeeding
Mental health conditions that could interfere with following study procedures
Taking medications that could interact with the study drugs
Participation in other clinical trials within the past 28 days
Unable to take blood-thinning medications if required during the study
History of severe allergic reactions to injectable medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
University Hospital Maastricht	Maastricht	The Netherlands
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Uidmrewluh Mjsagev Cbrnwn Hiafjguvebcbgwlln	Hamburg	Germany
Iqymqyxa Cvbaou Dnxjsryzbqatygebl	L'hospitalet De Llobregat	Spain
Irbmkhnp Rkntvyajp Pvz Ly Sushog Doy Txyjia Dryt Aqdrggu Inpq Sortty	Meldola	Italy
Aoewxstyq Uyi	Amsterdam	The Netherlands
Htigmwkr Ulmexryrzgsac Htmpbeqm Tblfl y Pkczxr Iyxjjzzh Cvjatd dvghlxlxenqosqskh (kbtp	Badalona	Spain
Hiikyloq Vnmj dpngahhn	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	14.10.2016
Germany	Not recruiting	14.10.2016
Italy	Not recruiting	14.10.2016
Spain	Not recruiting	14.10.2016
The Netherlands	Not recruiting	14.10.2016

Trial locations

Investigated drugs:

CC-220 is an experimental medication being studied for the treatment of multiple myeloma. It is being tested both alone and in combination with other medications.

Dexamethasone (DEX) is a steroid medication that helps reduce inflammation and suppress the immune system. It is commonly used in the treatment of multiple myeloma and other cancers.

Daratumumab (DARA) is a targeted therapy that works by helping the immune system attack cancer cells. It is specifically designed to treat multiple myeloma.

Bortezomib (BTZ) 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 and multiply.

Carfilzomib (CFZ) is also a proteasome inhibitor that works similarly to bortezomib. It is used in the treatment of multiple myeloma when other treatments have not been effective.

Investigated diseases:

Plasma cell myeloma

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to help fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancer cells produce large amounts of abnormal proteins instead of useful antibodies. The disease causes bones to weaken, leading to bone pain and increased risk of fractures. Multiple myeloma can also affect the body’s ability to make healthy blood cells, potentially leading to anemia and increased infections.

Trial ID:

2024-510799-19-00

Protocol code:

CC-220-MM-001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of iberdomide alone or with drug combinations for patients with multiple myeloma: testing safety and effectiveness of different doses

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?