Active not recruitingPHASE2INTERVENTIONAL

A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

This research is investigating new ways to treat a specific type of amyloidosis called AL amyloidosis, particularly when it affects the heart. The study aims to understand how safe a combination of medicines (Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone) is for the heart. It's also looking at how the main drug, Daratumumab, behaves in the body of different ethnic and racial groups. There are two main groups in the study: one where the combined treatment starts right away, and another where it starts later, after Daratumumab. Ultimately, the goal is to find better and safer treatments for people living with this condition.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

151

Start

01 Mar 2022

Estimated completion

22 Oct 2026

Amyloidosis

What is this study about?

This study is focused on people who have a condition called AL amyloidosis. This happens when abnormal proteins, called amyloid, build up in different organs of the body, which can stop them from working properly. A major concern in AL amyloidosis is when these proteins build up in the heart, as this can be very serious.

The main aim of this study is to look at a new combination of existing medicines – Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone – to see how safe they are, especially for the heart, when treating AL amyloidosis. Researchers are also trying to understand if there are ways to reduce any potential heart-related side effects. The study is divided into two main parts: one where people get all the medicines together from the start, and another where a key medicine, Daratumumab, is given first, followed by the others.

Another important aspect of this study is to understand how one of the main drugs, Daratumumab, travels through and is used by the body in people from different racial and ethnic backgrounds, particularly Black or African American individuals. This helps ensure that treatments are effective and safe for everyone. The overall goal is to improve the care and outcomes for people living with AL amyloidosis.

Key takeaways

The study focuses on new drug combinations for AL amyloidosis, especially when it affects the heart.
It aims to check the safety of these drugs for the heart and find ways to reduce side effects.
Researchers are also studying how one drug, Daratumumab, works in people from different backgrounds.
Participants must have AL amyloidosis affecting the heart or other organs.
Certain prior treatments or health conditions might prevent you from joining.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you must be at least 18 years old. If you have AL amyloidosis, you need to have heart involvement (for one group of the study) or have the disease affecting at least one organ (for the other group). Your general health and ability to perform daily activities, as assessed by a doctor, should be good enough to participate.

For women who could become pregnant, special tests will be needed to ensure you are not pregnant at the start of the study and throughout. Men taking part will need to agree not to donate sperm for a period after the study treatment finishes. For one specific part of the study, participants must identify as a racial or ethnic minority, including Black or African American.

There are also reasons why you might not be able to join. For instance, if you have recently received other treatments for AL amyloidosis or related conditions (like multiple myeloma), or if you have specific symptoms of multiple myeloma, you likely won't be eligible. You also can't have been on certain other experimental drugs or vaccines recently.

Quick self-check

Are you 18 years old or older?
Do you have AL amyloidosis that affects your heart or at least one other organ?
Is your general health good enough to participate, as assessed by your doctor?
Have you not received any previous treatment for AL amyloidosis or related conditions (like multiple myeloma) beyond a small dose of certain steroids?
If you are a woman of childbearing potential, are you willing to take pregnancy tests?
If you are a man, are you willing to agree not to donate sperm during and after the study period?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The detailed aspects of taking part, such as the number of clinic visits, specific tests, how you'll receive the medication, and how long you'll be followed after treatment, are not fully described here. However, typical drug studies involve regular hospital visits for blood tests, heart checks, and other medical examinations to monitor your health and how the treatment is working. You will be receiving specific medications (Daratumumab, Cyclophosphamide, Bortezomib, Dexamethasone) either alone or in combination. The total duration of your involvement, including follow-up, will be clearly explained by the study team if you are deemed eligible.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving new treatments for your AL amyloidosis that aren't yet widely available, and close medical monitoring. However, like all medications, those used in this study have potential side effects and risks, including impacts on the heart. The research team will discuss all known and potential risks with you in detail. Remember, your participation is completely 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 (46)

City of Hope
Duarte, United States
Yale
New Haven, United States
Moffitt Cancer Center
Tampa, United States
Winship Cancer Institute Emory University
Atlanta, United States
Tufts Medical Center
Boston, United States
Boston University Medical Center
Boston, United States
Barbara Ann Karmanos Cancer Institute
Detroit, United States
Memorial Sloan Kettering
New York, United States
Levine Cancer Institute
Charlotte, United States
Wake Forest University - Baptist Medical Center
Winston-Salem, United States
University Hospital of Cleveland
Cleveland, United States
Ohio Health Research Institute
Columbus, United States

+34 more sites — see the official record for the full list.

Common questions

What is AL amyloidosis?

AL amyloidosis is a rare condition where abnormal proteins build up in organs like the heart, kidneys, and liver, causing them to not work properly.

What are the main medicines being tested?

The study is looking at a combination of medicines: Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone.

Why is heart safety important in this study?

AL amyloidosis can seriously affect the heart, so researchers want to make sure the treatments are safe for the heart and find ways to protect it.

Who can join the study?

Adults (18+) with AL amyloidosis, specifically those with heart involvement or other affected organs, and generally good health, may be considered.

Will I have to pay to be in the study?

Generally, you do not pay to take part in clinical trials. All study-related treatments and tests are typically provided at no cost, but you should confirm this with the study team.