What is the LINKER-MGUS1 clinical research study?

If you were diagnosed with high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) or non-high-risk smoldering multiple myeloma (NHR-SMM), please know that you are not alone in your medical journey. HR-MGUS and NHR-SMM are disorders of clonal plasma cells, which are found in your blood and bone marrow. These conditions do not have any symptoms and are usually found when checking the blood for other reasons. There is no established therapy for these conditions. If diagnosed with one of these conditions, you have a 3-10% average annual risk of developing a blood cancer called multiple myeloma (MM). However, the hope is that early treatment may prevent HR-MGUS or NHR-SMM from progressing to MM. 
Currently, we are working on developing potential treatments for these precancerous conditions. LINKER-MGUS1 is a clinical research study that aims to understand how well an investigational study drug eliminates abnormal plasma cells (effectiveness) and how well the body reacts to the study drug (safety and tolerability) in people with HR-MGUS or NHR-SMM who are at moderate risk of developing MM.
This treatment is called “investigational” as it has not yet been approved to treat HR-MGUS and NHR-SMM. 

Am I eligible? 

Questionnaire

What is the study treatment?

The study treatment is an antibody-based drug, and it is given by intravenous (IV) infusion (a needle in your arm). Antibodies are proteins produced by your immune system to fight infections. The study treatment is a bispecific antibody, and it attaches to proteins on two different cell types: BCMA on plasma cells and CD3 on T cells. When T cells are linked to abnormal plasma cells by the study drug, it triggers your body’s immune system to attack the abnormal plasma cells and remove them, like when fighting an infection.
Participants will receive other medications to help them better tolerate the study drug, such as a steroid (dexamethasone), an antihistamine (diphenhydramine or equivalent), and a mild fever reducer (paracetamol).

There is no placebo or comparator treatment in this study, which means all participants will receive the investigational study drug.

What can I expect if I participate?

Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your roles and responsibilities if you join the LINKER-MGUS1 study. You may leave the study at any time without it affecting your regular health care.

If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures, including bone marrow aspirates and biopsies. The length of your participation in this study will vary depending on how well you respond to the study drug and what side effects you have from it. The longest period for this study is about 6 years (up to 7 months of treatment plus up to 5 years of follow-up after your last study drug dose). Some follow-up visits may be done remotely.
Participants may be reimbursed for travel and accommodation costs.

How can I take part?

If you wish to take part in LINKER-MGUS1, you can fill in a short pre-screener questionnaire to see if you may be eligible.

Am I eligible?

Questionnaire

What else should I know?

As with all medicines, there are possible risks when taking the investigational treatment. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study treatment may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.
You may benefit from additional check-ups on top of your regular care and have access to HR-MGUS and NHR-SMM specialists. There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the study for any reason and at any time.

Find a study site near you

To find out more about LINKER-MGUS1, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.

Find your nearest study site

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Am I Eligible?

If you wish to take part in the LINKER-MGUS1 clinical research study, fill in the pre-screener questionnaire below to see if you may be eligible.
You may be eligible if you:
Are 18 years old or older
Were diagnosed with HR-MGUS or NHR-SMM
Are not pregnant or planning to become pregnant or get your partner pregnant
There are other requirements to participate. A full medical check-up will be done to see if you can join this study. If you have other questions, share this website with your doctor to discuss this study.

Pre-screening questionnaire

You can see if you meet some of the requirements by completing the pre-screening questionnaire below. Just answer either “yes” or “no” to each question, then click the submit button. This questionnaire is completely anonymous – none of your personal data are saved.
This questionnaire does not contain all of the requirements you need to meet to participate. If you are eligible for this study, you will also receive a copy of the Informed Consent Form when you first visit the study site, which will include additional information.
  • Please click on the answer that best applies to you.

Find a study site near you

To find your nearest study site, please enter your zip code.