Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)

This research study is about a new way to treat a type of blood cancer called myelofibrosis. Doctors are testing a new drug, BMS-986158, by itself and in combination with two other medicines (Ruxolitinib or Fedratinib). The main goals are to find out if these treatments are safe for people to take, what side effects they might cause, and if they can help improve the condition. The study is divided into two main parts. First, it will look at BMS-986158 combined with Ruxolitinib or Fedratinib. Then, it will also include BMS-986158 on its own. This information helps doctors understand the best ways to use these treatments for patients with myelofibrosis.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Bristol-Myers Squibb

Enrolment target

216

Start

22 Mar 2021

Estimated completion

31 Aug 2028

Myelofibrosis

What is this study about?

This study is designed to explore a new treatment approach for myelofibrosis, a specific type of blood cancer. In myelofibrosis, the bone marrow, which is usually responsible for making blood cells, becomes scarred. This can lead to various problems, including tiredness, an enlarged spleen, and low blood cell counts. The researchers are particularly interested in a new drug called BMS-986158. They want to understand how it works, both by itself and when combined with other medicines that are already used for myelofibrosis, like Ruxolitinib or Fedratinib.

The main purpose of this study is to check if these treatments are safe for people with myelofibrosis, and to see if they can help ease the symptoms of the condition or slow its progress. It's an early-stage study, meaning that while these drugs have been tested before, this is a step towards understanding their full potential in treating myelofibrosis. By participating, you could help doctors learn more about this disease and potentially find new, better ways to treat it in the future.

Understanding the safety and effectiveness of new drugs is a very important step in developing new treatments. This study aims to gather important information that will one day help doctors make informed decisions about the best care options for people living with myelofibrosis.

Key takeaways

This study is testing a new drug for myelofibrosis.
It aims to find out if the new drug is safe and if it works.
The drug will be tested alone and with existing myelofibrosis treatments.
All adults (18+) with myelofibrosis may be eligible.
Participation involves regular clinic visits and health checks.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older, and have been diagnosed with myelofibrosis, specifically primary myelofibrosis, or myelofibrosis that developed after having essential thrombocythemia or polycythemia vera. If you've had previous treatments, any side effects from those treatments need to have mostly cleared up or returned to how they were before you started treatment.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, this study would not be suitable for you. Also, if you have any other serious or uncontrolled long-term health problems right now, you might not be able to take part. This is to ensure your safety throughout the study.

The health care team will discuss all the specific requirements with you to make sure this study is the right fit for your situation and that it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with primary myelofibrosis, or myelofibrosis after similar blood conditions?
Have any side effects from previous treatments mostly gone away?
Are you not pregnant or breastfeeding?
Do you not have any other serious, uncontrolled health problems right now?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular visits to the clinic for check-ups. These visits will involve various assessments, such as blood tests, physical examinations, and possibly other tests to monitor your health and how the treatment is affecting you. You'll be given the study medication, which could be BMS-986158 alone or in combination with Ruxolitinib or Fedratinib, to take as directed. The doctors and nurses will explain exactly how and when to take your medication. Following your main treatment period, there will be follow-up visits to continue checking on your health and any effects of the treatment. The total duration of your involvement in the study will be explained to you by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new treatment that isn't widely available yet and might improve your condition. You would also play a role in advancing medical knowledge for myelofibrosis. However, like all medicines, the study drugs may have side effects, and it's possible that the treatment might not work for you. The study team will carefully monitor you for any side effects and ensure you understand all known risks. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (49)

Local Institution - 0069
Verified postcode
Newport Beach, United States
Local Institution - 0090
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Lake Mary, United States
Local Institution - 0043
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New Orleans, United States
Local Institution - 0038
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Worcester, United States
Local Institution - 0033
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Ann Arbor, United States
Local Institution - 0045
Verified postcode
Hackensack, United States
Local Institution - 0076
Verified postcode
Chapel Hill, United States
Local Institution - 0042
Verified postcode
Pittsburgh, United States
Local Institution - 0036
Verified postcode
Blacktown, Australia
Local Institution - 0032
Verified postcode
Wollongong, Australia
Local Institution - 0007
Verified postcode
East Melbourne, Australia
Local Institution - 0006
Verified postcode
Heidelberg, Australia

Common questions

What is myelofibrosis?

Myelofibrosis is a rare type of blood cancer where the bone marrow, which makes blood cells, becomes scarred, leading to problems like tiredness and low blood counts.

What is BMS-986158?

BMS-986158 is a new drug being tested in this study to see if it can help treat myelofibrosis. It's being looked at alone and with other medicines.

Will I know which treatment I'm getting?

The study team will explain how the treatments are given. In some parts of the study, you might know, while in others, it might be decided by chance, but your doctor will provide details.

How long will the study last for me?

The exact length of time you would be involved in the study would be discussed with you by the research team, as it can vary depending on individual patient needs and the study design.

Can I stop participating in the study if I want to?

Yes, absolutely. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.