Active not recruitingPHASE1INTERVENTIONAL

Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002 (MK-4002-001)

Doctors are studying a new medicine called MK-4002, also known as HPN217. This medicine is for people with multiple myeloma, a type of blood cancer, that has either returned after previous treatment or isn't getting better with current medicines. The main goals of this study are to figure out the safest and most effective dose of MK-4002. They also want to understand how people's bodies react to the treatment over time and how well they can tolerate it. By taking part, you could help researchers learn more about this potential new medicine and improve future treatments for multiple myeloma.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Enrolment target

100

Start

13 Apr 2020

Estimated completion

31 Dec 2026

Multiple Myeloma in Relapse Multiple Myeloma Multiple Myeloma of Bone Multiple Myeloma With Failed Remission

What is this study about?

This study is looking into a new treatment called MK-4002, which is also known as HPN217. It's designed for people who have multiple myeloma that has either relapsed (come back after getting better) or is refractory (not responding well to existing treatments). When someone has relapsed or refractory multiple myeloma, it means the usual ways of treating the cancer haven't worked as hoped, and new options are needed.

The main purpose of this study is to explore if MK-4002 could be a helpful new medicine for this condition. The research team wants to find the right amount of the medicine to give, which is called the dose. They need to make sure the dose is safe and that people can take it without too many uncomfortable side effects. They also want to understand what the medicine does inside the body and how long it stays there.

By taking part in this study, you would be helping doctors learn more about this new potential treatment. This research is very important because it could lead to new ways of helping people with multiple myeloma in the future. It's a phase 1 study, which means it's one of the first times this medicine is being tested in people. This helps researchers understand its basic safety and how it works before moving on to larger studies.

Key takeaways

This study is testing a new medicine (MK-4002/HPN217) for multiple myeloma that has come back or isn't responding to other treatments.
The main goals are to find a safe dose and understand how the medicine works in the body.
It's a 'Phase 1' study, meaning it's an early stage of testing in people.
Participation involves regular visits, tests, and taking the study medicine.
You must be 18 or older and have certain types of multiple myeloma to be eligible.
Taking part could offer a new treatment option, but there are also potential risks as it's a new medicine.

Who may be eligible?

To join this study, you must be at least 18 years old and have multiple myeloma that has come back or isn't responding to other treatments. You would typically have tried at least three different therapies already, including some common types of multiple myeloma drugs. Your doctors must feel that current standard treatments are unlikely to work well for you.

Another important requirement is that your multiple myeloma needs to be 'measurable.' This means doctors can detect and track your cancer using blood or urine tests. Also, any side effects from your previous treatments should have mostly gone away or be very mild before you start this study.

There are also some reasons why you couldn't join. For example, if you have a very specific type of myeloma called plasma cell leukaemia, or certain other conditions like some autoimmune diseases. If you've had certain types of stem cell transplants recently, you might also not be able to take part.

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?
Do you have multiple myeloma that has come back or is no longer responding to treatments?
Have you already tried at least three different types of myeloma treatments?
Do your doctors believe standard treatments are unlikely to work for you now?
Can your multiple myeloma be seen and measured by doctors (e.g., through blood tests)?
Have any side effects from your past treatments mostly cleared up?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new study medicine, MK-4002. The study will involve regular visits to the clinic so that the doctors can check on your health, see how you are responding to the medicine, and monitor for any side effects. These visits will include various tests, such as blood tests, urine tests, and possibly other scans to track your multiple myeloma.

The research team will carefully monitor you throughout the study. You will be given the study medicine according to a specific schedule, and the doses might be adjusted based on how you respond. The total duration of your participation will depend on how you react to the treatment and other factors, and the study team will explain this fully. There will also be follow-up appointments after you stop taking the study medicine.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. The potential benefit of this study is that MK-4002 could help treat your multiple myeloma, especially if other treatments haven't worked or stopped working. However, as this is a new medicine, there might be side effects or risks that are not fully known yet. The research team will carefully monitor you, but there's no guarantee the treatment will be effective, or that you won't experience side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (12)

Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
Mayo Clinic Arizona
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Phoenix, United States
UC San Diego Moores Cancer Center
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La Jolla, United States
The University of Kansas Cancer Center
Verified postcode
Fairway, United States
Roswell Park Comprehensive Cancer Center
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Buffalo, United States
University of Rochester James P Wilmot Cancer Institute
Verified postcode
Rochester, United States
OHSU
Verified postcode
Portland, United States
University of Washington - Seattle Cancer Center Alliance
Verified postcode
Seattle, United States
Centre Hospitalier Universitaire De Nantes
Verified postcode
Nantes, France
Centre Hospitalier Universitaire de Poitiers
Verified postcode
Poitiers, France
Josep Carreras Leukaemia Research Institute
Verified postcode
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)
Verified postcode
Madrid, Spain

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects a specific kind of white blood cell called plasma cells, found in your bone marrow.

What does 'relapsed or refractory' mean?

It means the cancer has either returned after getting better with previous treatment (relapsed), or it hasn't improved or has gotten worse with current treatments (refractory).

What is MK-4002?

MK-4002 (also known as HPN217) is a new medicine being tested in this study to see if it can treat multiple myeloma.

What is a 'Phase 1' study?

A Phase 1 study is one of the first times a new medicine is given to people. The main goals are to find a safe dose and understand how the body handles the medicine.

Will I get paid to be in the study?

Clinical trials usually don't pay you to participate, but often cover study-related costs or provide travel assistance. You should discuss this with the study team.