Study on the Safety and Effectiveness of Mezigdomide and Dexamethasone for Patients with Relapsed and Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition called multiple myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is specifically looking at cases where the myeloma has either returned after treatment or has not responded to previous treatments. The trial will test a new treatment involving a medication called CC-92480, also known by its code name BMS-986348 or mezigdomide. This medication will be used alone and in combination with another drug called dexamethasone, which is a type of steroid that helps reduce inflammation and is often used in cancer treatment.

The purpose of the study is to determine the safety and effectiveness of CC-92480 both on its own and when combined with dexamethasone. Participants in the study will receive the medication in capsule form, taken by mouth. The study will be conducted in two parts. In the first part, researchers will focus on understanding how the body processes the medication and identifying the best dose to use. In the second part, the study will expand to include more participants to further evaluate how well the treatment works in controlling the disease.

Throughout the study, participants will be monitored for any side effects and changes in their condition. The trial aims to provide valuable information on the potential benefits of CC-92480 for people with relapsed or refractory multiple myeloma, which could lead to new treatment options for this challenging condition. The study is expected to continue until early 2028, allowing researchers to gather comprehensive data on the treatment’s long-term effects and overall impact on the disease.

1 joining the study

Upon joining the study, the patient will begin by taking part in a clinical trial designed to evaluate the safety and effectiveness of a medication called CC-92480, also known as mezigdomide, both alone and in combination with another medication called dexamethasone.

The trial is intended for individuals with a type of cancer known as relapsed and refractory multiple myeloma, which means the cancer has returned or is not responding to previous treatments.

2 medication administration

The patient will receive CC-92480 in the form of capsules, which are taken orally. The dosage of CC-92480 may vary, including options such as 0.1 mg, 0.2 mg, 0.5 mg, 0.6 mg, 0.8 mg, 1 mg, and 2 mg.

In combination therapy, dexamethasone will also be administered orally in tablet form, with available dosages of 4 mg and 8 mg.

3 treatment schedule

The treatment schedule involves taking CC-92480 daily for 21 days, followed by a 7-day break, making a complete cycle of 28 days. This is referred to as the QD 21/28 dosing schedule.

When combined with dexamethasone, the specific dosing schedule will be determined based on the patient’s response and tolerance to the treatment.

4 monitoring and assessments

Throughout the trial, the patient’s health will be closely monitored through regular assessments, including physical examinations, blood tests, and other necessary evaluations to track the safety and effectiveness of the treatment.

The primary focus will be on identifying any side effects, understanding how the body processes the medication, and determining the most effective dose.

5 trial duration

The estimated end date for the trial is January 31, 2028. The duration of participation for each patient may vary depending on individual response to the treatment and other factors.

The trial aims to gather comprehensive data on the overall response rate, time to response, duration of response, progression-free survival, and overall survival.

Who Can Join the Study?

The person must be at least 18 years old when signing the informed consent form.
Men must agree not to donate sperm while taking the study drug and for 94 days after the last dose. Women must agree not to donate eggs while taking the study drug and for 184 days after the last dose.
All participants must agree not to donate blood while taking the study drug and for 28 days after stopping it.
The person must understand and voluntarily sign an informed consent form before any study-related tests or procedures are done.
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 helps assess how well a person can perform daily activities.
The person must have a confirmed diagnosis of multiple myeloma (MM) and measurable disease at the time of joining the study. Measurable disease means having certain levels of specific proteins or markers in the blood or urine.
The person must have received at least 3 previous treatments for multiple myeloma, including specific drugs and therapies, and have shown disease progression within 60 days of the last treatment. If the last treatment was CAR-T therapy, the person is eligible if the disease progressed after this therapy.
The person must have certain laboratory test results, such as:
- Absolute neutrophil count (ANC) of at least 1.25 x 10⁹/L without growth factor support for at least 7 days.
- Hemoglobin (Hgb) level of at least 8 g/dL.
- Platelet count of at least 75 x 10⁹/L without transfusion for at least 7 days.
- Corrected serum calcium level of 13.5 mg/dL or lower.
- Creatinine clearance (CrCl) of at least 45 mL/min, which measures kidney function.
- AST/SGOT and ALT/SGPT levels no more than 3 times the upper limit of normal, which are liver enzymes.
- Serum bilirubin level no more than 1.5 times the upper limit of normal, or less than 3.0 mg/dL for those with Gilbert’s syndrome.
- Uric acid level of 7.5 mg/dL or lower.
- PT/INR and partial thromboplastin time (PTT) less than 1.5 times the upper limit of normal, for those not on blood thinners.
Women who can have children must have two negative pregnancy tests before starting the study drug and agree to ongoing pregnancy testing during and after the study. They must also agree to use two reliable forms of birth control or practice true abstinence from heterosexual contact.
Men must practice true abstinence or agree to use a condom during sexual contact with a pregnant woman or a woman who can have children while in the study and for at least 94 days after the last dose of the study drug, even if they have had a vasectomy.

Who Cannot Join the Study?

Patients who have not been diagnosed with relapsed and refractory multiple myeloma (RRMM). This is a type of blood cancer that has returned after treatment and does not respond to standard treatments.
Patients who are not within the specified age range for the study.
Patients who are not able to safely take the study medications due to other health conditions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have certain infections or other serious health issues that could interfere with the study.
Patients who are unable to follow the study procedures or attend required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hiujzqvt Du Lk Spbsx Cfmo I Sazm Pze	Barcelona	Spain
Hfnobqcb Unrrixetaxjuj Hqfyseez Tbdjj y Phzjmb Ixacvbeq Cmigrv drxpeahsjyovpkjrn (beka	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	14.05.2018
Spain	Not recruiting	14.05.2018

Trial locations

Investigated Drugs:

CC-92480: This medication, also known as BMS-986348 and mezigdomide, is being studied for its effects on multiple myeloma, a type of blood cancer. The trial is exploring how well it works on its own and in combination with another medication. Researchers are looking at how the body processes this drug, its safety, and the best dose to use in future studies.

Dexamethasone: This is a type of steroid medication that is often used to reduce inflammation and suppress the immune system. In this trial, it is being used in combination with CC-92480 to see if it can help improve the treatment of multiple myeloma. The study aims to understand how effective this combination is in treating the disease.

Investigated Diseases:

Relapsed and Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In relapsed and refractory multiple myeloma, the disease returns after treatment or does not respond to standard therapies. It typically progresses by causing an overproduction of abnormal plasma cells, leading to bone damage, kidney problems, and a weakened immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can become more aggressive over time, making it challenging to manage.

Trial ID:

2023-508727-12-00

Protocol code:

CC-92480-MM-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Mezigdomide and Dexamethasone for Patients with Relapsed and Refractory Multiple Myeloma

What is this study about?

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