Study on the Safety and Effects of CC-92480 with Dexamethasone and Drug Combinations 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 or Refractory Multiple Myeloma, a type of blood cancer that has returned or is not responding to treatment. The study is exploring the use of a new treatment called CC-92480 (also known by its code name BMS-986348) in combination with other medications. These medications include dexamethasone, a steroid that helps reduce inflammation, tazemetostat, a drug that targets specific proteins in cancer cells, BMS-986158, and trametinib, which is used to block certain pathways that cancer cells use to grow.

The purpose of this study is to determine how safe and tolerable these combinations are for patients with Relapsed or Refractory Multiple Myeloma. Participants will receive these medications in different combinations to find the best dose and schedule. The study will monitor the safety of these treatments by observing any side effects and how often they occur. The study will also look at how well the treatments work in controlling the disease.

Participants in the study will take the medications orally, meaning they will swallow them in the form of capsules or tablets. The study will continue until the researchers gather enough information to understand the safety and effectiveness of the treatment combinations. The goal is to find the most effective and safe way to use these medications together to help manage Relapsed or Refractory Multiple Myeloma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

The assessment ensures that the patient has relapsed or refractory multiple myeloma and meets other criteria such as age and performance status.

2 treatment initiation

The treatment phase begins with the administration of the study medications. The primary medication is CC-92480, taken orally in capsule form.

Additional medications include dexamethasone and either tazemetostat, BMS-986158, or trametinib, depending on the specific combination assigned.

3 medication schedule

The dosage and frequency of each medication are determined based on the specific combination and the patient’s response. CC-92480 is available in various dosages, such as 0.1 mg, 0.2 mg, 0.6 mg, 0.8 mg, and 1 mg.

Dexamethasone is administered in 4 mg tablets, while tazemetostat and trametinib are provided in tablet form as well.

4 monitoring and evaluation

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes tracking any side effects and adjusting dosages as necessary.

The study aims to determine the recommended phase 2 dose and schedule for each combination.

5 response assessment

The patient’s response to the treatment is evaluated using criteria such as overall response rate, complete response rate, and progression-free survival.

These assessments help determine the effectiveness of the treatment in managing multiple myeloma.

6 study completion

The study is expected to conclude by February 28, 2025. At this point, a final evaluation of the patient’s health and response to the treatment is conducted.

The results contribute to understanding the safety and efficacy of the treatment combinations for relapsed or refractory multiple myeloma.

Who Can Join the Study?

You must sign a written informed consent before any study procedure begins. This means you agree to participate and understand what the study involves.
You need to be at least 18 years old at the time you sign the consent form.
You must have a condition called relapsed or refractory multiple myeloma. This means your myeloma has returned after treatment or has not responded to treatment. You should have:
- Proof that your disease has gotten worse during or after your last treatment for myeloma.
- Been unable to benefit from other available treatments, either because they didn’t work, you couldn’t tolerate them, or they are not suitable for you.
You must have a measurable disease, which means the disease can be measured or tracked by the doctors.
Your Eastern Cooperative Oncology Group Performance Status (ECOG PS) should be 0 or 1. This is a scale used to assess how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you are restricted in physically strenuous activity but can carry out light work.
If you are of childbearing potential, you must agree to follow the CC-92480 Pregnancy Prevention Plan (PPP) to prevent pregnancy during the study.

Who Cannot Join the Study?

Patients who have not experienced a return of their cancer or whose cancer has not stopped responding to treatment cannot participate.
Patients who are not diagnosed with Relapsed or Refractory Multiple Myeloma (RRMM) cannot participate. This means the cancer has returned after treatment or has not responded to treatment.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who do not meet the specific health and safety requirements set by the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hxpkyouj Uzxprysjuvwrf Mrcfnmv Dp Vczqkrwozp	Santander	Spain
Iibtgmkj Cvlfkx Djzxoregoflikhwjr	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	19.10.2022
Spain	Recruiting	19.10.2022

Trial locations

Investigated drugs:

CC-92480 is an investigational medication being studied for its potential to treat relapsed or refractory multiple myeloma. It is being tested in combination with other therapies to evaluate its safety and how well it works in patients who have not responded to previous treatments.

Dexamethasone is a type of steroid medication that is commonly used to reduce inflammation and suppress the immune system. In this trial, it is used in combination with other drugs to help treat multiple myeloma.

Tazemetostat is a medication that targets specific proteins involved in cancer cell growth. It is being studied in combination with other treatments to see if it can help control multiple myeloma in patients who have not responded to other therapies.

BMS-986158 is an investigational drug being tested for its potential to treat multiple myeloma. It is being used in combination with other medications to assess its safety and effectiveness in patients with this type of cancer.

Trametinib is a medication that inhibits certain proteins involved in cancer cell growth. It is being studied in combination with other drugs to determine if it can help manage multiple myeloma in patients who have not had success with other treatments.

Relapsed or Refractory Multiple Myeloma – This is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the cancer has either returned after treatment (relapsed) or has not responded to treatment (refractory). It typically progresses by causing an overproduction of abnormal plasma cells, leading to bone damage, kidney problems, and a weakened immune system. As the disease advances, it can result in symptoms such as bone pain, fatigue, and frequent infections. The progression of the disease can vary, with periods of stability followed by periods of active disease.

Trial ID:

2023-509384-25-00

Protocol code:

CA057-003

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of CC-92480 with Dexamethasone and Drug Combinations for Patients with Relapsed or Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?