Study on Continuing Elotuzumab Treatment for Patients with Multiple Myeloma from Previous Trials

2 1 1 1

What is this study about?

This clinical trial focuses on the treatment of Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study involves the use of a medication called Elotuzumab, which is administered as a solution for infusion. The purpose of the study is to provide Elotuzumab and/or other study drugs to participants who have previously been part of a trial investigating Elotuzumab and are unable to receive the medication through commercial means.

Participants in this study will continue to receive Elotuzumab and/or other study drugs as they did in their previous trial. The study will monitor the number of participants who receive at least one dose of Elotuzumab or other therapies, as well as the duration of their treatment. Additionally, the study will collect information on any serious adverse events (SAEs), Grade 5 adverse events (AEs), new AEs, and AEs that lead to discontinuation of the treatment. These events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE).

The trial is designed to ensure that participants who have benefited from Elotuzumab in previous studies can continue their treatment. The study will run until the end of 2024, providing ongoing access to the medication for those who need it. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the effects of the treatment.

1 joining the study

Participation in this study is for individuals who have previously been part of a trial involving elotuzumab and are currently benefiting from it.

Eligibility requires that you are already receiving elotuzumab or other study drugs at the time of signing the consent form.

Participants must be 18 years or older.

2 treatment administration

Elotuzumab is administered as a solution for infusion, which means it is given through a vein (intravenous use).

The specific dosage and frequency of administration will be determined based on the previous protocol you participated in.

3 monitoring and data collection

The study will collect data on the number of participants who receive at least one dose of elotuzumab or other study drugs, as well as the duration of treatment.

Any serious adverse events (SAEs), severe adverse events (Grade 5 AEs), new adverse events, or those leading to discontinuation will be recorded.

Adverse events and symptoms will be assessed using a standardized grading system.

4 study duration

The estimated end date for the study is December 31, 2024.

The study began recruiting participants on November 20, 2020.

Who Can Join the Study?

You must have participated in a previous study involving elotuzumab. Elotuzumab is a type of medication used in treating certain conditions.
The previous study could include studies like HuLuc63-1703, CA204007, CA204009, or CA204011.
The doctor must believe that you are benefiting from elotuzumab or other study medications based on the previous study.
You must be currently receiving elotuzumab or other study medications when you sign the consent form to join this study.
You must be at least 18 years old or the legal age of adulthood in your area.
Both males and females can participate in the study.

Who Cannot Join the Study?

Patients who have not participated in a previous study involving the drug elotuzumab cannot join. Elotuzumab is a medication used in treating certain types of cancer.
Patients who are able to receive the drug elotuzumab through regular commercial means are not eligible. This means if you can get the drug outside of the study, you cannot participate.
Patients who are part of a vulnerable population are not allowed to join. A vulnerable population includes groups like children, pregnant women, or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Spitalul Clinic Coltea	Bucharest	Romania
Institutul Regional De Oncologie Iasi	Iasi	Romania

Trial status

Country	Status	Recruitment Start
Romania	Not recruiting	20.11.2020

Trial locations

Investigated drugs:

Elotuzumab is a medication used in this clinical trial. It is designed to help the immune system target and attack certain cancer cells. Participants in this trial have previously been involved in studies with elotuzumab and will continue to receive it as part of their treatment. The goal is to provide ongoing access to this medication for those who cannot obtain it through commercial means.

Investigated diseases:

Plasma cell myeloma

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones and kidneys. As the disease progresses, it can result in bone pain, fractures, and anemia due to the crowding out of healthy blood cells. Patients may also experience frequent infections because the immune system is compromised. Over time, the accumulation of these abnormal cells can lead to organ dysfunction and other complications.

Trial ID:

2024-515490-10-00

Protocol code:

CA204-185

NCT ID:

NCT02719613

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Continuing Elotuzumab Treatment for Patients with Multiple Myeloma from Previous Trials

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?