Study on Mezigdomide, Carfilzomib, and Dexamethasone for Patients with Relapsed, Refractory, or Newly Diagnosed Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves patients with both relapsed or refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The main purpose of the study is to determine the best dose and schedule, as well as to evaluate the safety and initial effectiveness of a new treatment called mezigdomide, which is being tested in combination with standard treatments.

The study will use several medications, including Kyprolis (carfilzomib), Dexamethasone, CC-92480 (mezigdomide), Darzalex (daratumumab), Velcade (bortezomib), and Empliciti (elotuzumab). These medications are administered in different forms such as tablets, capsules, and solutions for injection or infusion. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

Participants in the study will receive these treatments over a period of time, and their health will be closely monitored to assess how well the treatment works and to identify any side effects. The study aims to find the most effective and safe way to use mezigdomide in combination with other treatments for multiple myeloma. The trial is expected to continue until 2026, with ongoing assessments of participants’ responses to the treatment.

1 joining the study

Upon joining the study, the patient will be required to sign an informed consent form. This confirms understanding and agreement to participate in the trial.

The patient must be at least 18 years old and meet specific health criteria, including a performance status score of 0, 1, or 2, which measures the ability to perform daily activities.

2 initial assessment

An initial assessment will be conducted to evaluate the patient’s health status and eligibility for the trial. This may include physical examinations and laboratory tests.

3 treatment phase

The treatment phase involves administering a combination of medications. The main medication being tested is mezigdomide, which is given in combination with standard treatments for multiple myeloma.

Medications include carfilzomib (Kyprolis) administered intravenously, dexamethasone taken orally, and mezigdomide in capsule form. Other medications like daratumumab (Darzalex) and bortezomib (Velcade) may be administered subcutaneously or intravenously.

The dosage and frequency of these medications will be determined based on the specific treatment regimen assigned to the patient.

4 monitoring and follow-up

Throughout the trial, the patient’s response to treatment will be closely monitored. This includes regular visits to the study site for assessments and tests.

The primary focus is to determine the recommended dose and regimen of mezigdomide and evaluate its safety and effectiveness when combined with other treatments.

5 completion of the trial

Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall response to the treatment.

The trial aims to measure outcomes such as the time to response, duration of response, and overall response rate.

Who Can Join the Study?

The person must be at least 18 years old when they sign the consent form.
The person must understand and willingly sign a consent form before any study-related activities begin.
The person must be willing and able to follow the study visit schedule and other study requirements.
The person must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. This score is a way to measure how well a person can perform daily activities.
Females who can have children must agree to follow all testing and birth control requirements as outlined in the mezigdomide Global Pregnancy Prevention Plan (PPP). The duration of birth control depends on the specific treatment they receive.
Male participants must agree to follow all requirements in the mezigdomide Global PPP. The duration of birth control depends on the specific treatment they receive, even if they have had a successful vasectomy.
Male participants must agree not to donate sperm or semen for a certain period after their last dose of treatment, as specified in the mezigdomide Global PPP.
Females must agree not to donate egg cells (ova) as specified in the mezigdomide Global PPP.
All participants must agree not to donate blood while receiving study treatment and for 28 days after the last dose of study treatment.
All male and female participants must follow all other requirements defined in the mezigdomide Global PPP.

Who Cannot Join the Study?

Patients who have a different type of cancer other than multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects certain blood cells in the bone marrow.
Patients who are not diagnosed with relapsed or refractory multiple myeloma (RRMM) or newly diagnosed multiple myeloma (NDMM) are excluded. Relapsed means the cancer has returned after treatment, and refractory means the cancer does not respond to treatment.
Patients who are under the age of 18 cannot participate in the study.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Odense University Hospital	Odense	Denmark
Alexandra Hospital	Athens	Greece
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Rigshospitalet	Copenhagen	Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hkihnnsj Ugjtvkpkuxpor Mgenbta De Vjmahrmrwt	Santander	Spain
Ccycxg Hdrhffgikcz Rxdinumz Uhekwpngxqlmw Do Tnlup	Tours	France
Udanlfdtetqgupwksewep Wusntygit Agy	Wuerzburg	Germany
Hzowrhve Uscrblwdroowu Hkjuewhf Tupch y Pnqzlt Imvadwxd Cfxqif dlgiqgvkebfickkvt (dofa	Badalona	Spain
Iyxqhesz Pvugvbelxrlxshe Cbybvm Ccnxmv	Marseille	France

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	15.10.2019
France	Not recruiting	15.10.2019
Germany	Not recruiting	15.10.2019
Greece	Not recruiting	15.10.2019
Italy	Not recruiting	15.10.2019
Spain	Not recruiting	15.10.2019

Trial locations

Investigated drugs:

Mezigdomide is a medication being studied for its potential to treat multiple myeloma, a type of blood cancer. In this clinical trial, researchers are testing mezigdomide in combination with other standard treatments to find the best dose and to see how safe and effective it is for patients who have either relapsed or refractory multiple myeloma, as well as those who are newly diagnosed.

Investigated diseases:

Plasma cell myeloma

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 this disease, abnormal plasma cells multiply uncontrollably, leading to bone damage, kidney problems, and a weakened immune system. The disease can be classified into different stages, with symptoms ranging from bone pain and fatigue to more severe complications as it progresses. Relapsed or refractory multiple myeloma refers to cases where the disease returns after treatment or does not respond to standard therapies. Newly diagnosed multiple myeloma indicates the initial identification of the disease in a patient. The progression of multiple myeloma can vary, with some patients experiencing slow development while others may have a more aggressive form.

Trial ID:

2023-505219-19-00

Protocol code:

CC-92480-MM-002

NCT ID:

NCT03989414

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Mezigdomide, Carfilzomib, and Dexamethasone for Patients with Relapsed, Refractory, or Newly Diagnosed Multiple Myeloma

What is this study about?

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