What is the LINKER-MM4 clinical research study?
If you were recently diagnosed with multiple myeloma (MM), please know that you are not alone in your medical journey. Multiple myeloma is a cancer of the blood’s plasma cells and accounts for approximately 13% of all cancers of the blood.
Currently, we are developing potential treatments for MM. LINKER-MM4 is a clinical research study that aims to test the safety, tolerability (how your body reacts), and efficacy (reduction in the number of cancer cells in your blood) of an investigational study drug in treating people with newly diagnosed MM.
This treatment is called “investigational” as it has not yet been approved to treat MM.
LINKER-MM4 consists of 2 parts:
Part 1 will evaluate the study drug and
determine its best dosage regimen in a
small number of people.
determine its best dosage regimen in a
small number of people.
Part 2 will observe the study drug in 80
participants based on the dose
determined in Part 1. Depending on your
eligibility, you may receive high dose
chemotherapy (HDT) and autologous
stem cell transplantation (ASCT) in
combination with the study drug.
participants based on the dose
determined in Part 1. Depending on your
eligibility, you may receive high dose
chemotherapy (HDT) and autologous
stem cell transplantation (ASCT) in
combination with the study drug.
Eligibility >>
What is the study drug?
The study drug is a bispecific antibody. Antibodies are proteins naturally found in your blood that help fight infections. Bispecific means the antibody has two different functions. A bispecific antibody can “lock” onto both a cancer cell and an immune cell, directing the immune system to destroy the cancer cell. This bispecific antibody attaches to BCMA, a protein found at a higher rate on cancerous plasma cells, and CD3, a protein found on a type of immune cell called a T-cell. The study drug is thought to activate the T-cell immune response to target myeloma cells and remove them in the same way as if they were fighting an infection.
No matter which treatment part or group you join, you will receive the study drug as an intravenous (IV) infusion (a needle in your arm).
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-MM4 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, such as bone marrow biopsies and imaging scans. The length of your participation is expected to be at least 28 weeks but will depend on which phase of the study you participate in, whether you receive HDT/ASCT, and your response to the study drug.
The length of your participation is expected to be at least 28 weeks
You will be reimbursed for travel to and from study visits, and medical care related to your participation, including the study treatment, will be provided at no cost. However, you or your health insurance will be responsible for treatments and procedures that are part of your standard MM care. The study team is available to discuss all of this with you.
How can I take part?
If you wish to take part in LINKER-MM4, you will need to fill in a short pre-screener questionnaire to see if you may be eligible.
Eligibility >>
What else should I
know?
As with all treatments, there are possible risks when taking the investigational study drug. 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 drug may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.
If you choose to participate, you may benefit from additional check-ups on top of your regular care and have access to MM 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.
Find a study site near you
To find out more about LINKER-MM4, 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 >>
Am I Eligible?
If you wish to take part in the LINKER-MM4 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
• Were diagnosed with MM
• Have not been previously treated for MM or have only received limited treatment for MM
• Are not pregnant, breastfeeding, planning to become pregnant, or planning to 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.