About the MMyrelis Clinical Research Study
The MMyrelis clinical research study is a phase 3 study evaluating whether an investigational study drug can help prevent infections in people receiving an approved Multiple Myeloma treatment.
What are the drugs in this study and how do they work?
Investigational study drug:
This investigational study drug contains immunoglobulin antibodies that help the body fight off infections. It is administered as an infusion through the vein and is approved for use in 66 countries globally for infection prevention in immune disorders starting from birth or early in life. It’s called “investigational” because it has not yet been approved for infection prevention in patients with Multiple Myeloma.
This investigational study drug contains immunoglobulin antibodies that help the body fight off infections. It is administered as an infusion through the vein and is approved for use in 66 countries globally for infection prevention in immune disorders starting from birth or early in life. It’s called “investigational” because it has not yet been approved for infection prevention in patients with Multiple Myeloma.
Multiple Myeloma study treatment:
Teclistamab has been approved as a treatment for Multiple Myeloma and works by attaching to two different targets in the body; one on Multiple Myeloma cells and another on a type of immune cell called T cells. This binding brings the T cells close to the cancer cells, helping the immune system to effectively attack and destroy the Multiple Myeloma cells.
Teclistamab has been approved as a treatment for Multiple Myeloma and works by attaching to two different targets in the body; one on Multiple Myeloma cells and another on a type of immune cell called T cells. This binding brings the T cells close to the cancer cells, helping the immune system to effectively attack and destroy the Multiple Myeloma cells.
With this research, it is hoped that the investigational study drug will help prevent infections in people being treated for Multiple Myeloma with teclistamab or other similar therapies.
What will happen during the study?
If you meet the study eligibility requirements and choose to participate in the MMyrelis clinical research study:
The study doctor and team will review the study with you to ensure you’re comfortable with what the study will ask of you, through the Informed Consent Process. This is your opportunity to ask as many questions as you wish and to take all the time you need as you consider joining. After your questions have been answered and if you decide to join the study, you will sign an Informed Consent Form and begin the next steps of the clinical research study.
There are three parts to the MMyrelis clinical research study: a screening period, an observation period, and the end of the study for a study duration of up to 14 months.
Screening (up to 8 weeks):
If you choose to take part in this study and sign the informed consent, you will undergo a screening period of up to 8 weeks during which your study doctor will determine if you qualify to take part in the study.
If you choose to take part in this study and sign the informed consent, you will undergo a screening period of up to 8 weeks during which your study doctor will determine if you qualify to take part in the study.
Observation period (up to 12 months):
In this clinical research study, you will be randomly (like drawing straws) assigned by a computer to 1 of 2 groups. Group A will have twice as many people as Group B. The maximum time you will be in the observational period of the study is 12 months (from the time you are assigned to a group) as described below:
In this clinical research study, you will be randomly (like drawing straws) assigned by a computer to 1 of 2 groups. Group A will have twice as many people as Group B. The maximum time you will be in the observational period of the study is 12 months (from the time you are assigned to a group) as described below:
Group A:
If you join this group, you will receive the investigational study drug within 3 days of being assigned to the group.
If you join this group, you will receive the investigational study drug within 3 days of being assigned to the group.
Group B:
If you join this group, your study doctor will monitor your health and provide you with all necessary treatments until you experience a serious infection. If your study doctor determines you have a serious infection, then you will receive the investigational study drug immediately, and every 3 or 4 weeks after. If you do not experience a serious infection during the study period, you will not receive the investigational study drug.
If you join this group, your study doctor will monitor your health and provide you with all necessary treatments until you experience a serious infection. If your study doctor determines you have a serious infection, then you will receive the investigational study drug immediately, and every 3 or 4 weeks after. If you do not experience a serious infection during the study period, you will not receive the investigational study drug.
Both groups will receive the investigational study drug, every 3 or 4 weeks, whichever works for you and your doctor.
End of Study Visit (1 day):
This visit takes place on the last day of the clinical research study.
This visit takes place on the last day of the clinical research study.
What will happen at study visits?
At study visits, participants will discuss health updates with the study doctor and complete study-related assessments and procedures, such as:
Weight and height
Measurement of vital signs (body temperature, respiratory rate, blood pressure, and pulse rate)
Physical exam
Investigational study drug infusion
Collection of blood and urine samples
Health questionnaires
Study visits may also include assessments and procedures not listed here. The study doctor and team will review the visit schedule with you and explain the assessments and procedures.
What will be my responsibilities during this study?
Clinical research studies like the MMyrelis clinical research study rely on the commitment and participation of volunteers.
In the MMyrelis clinical research study, your responsibilities will include:
- Following instructions from the study doctor and study team.
- Coming to every study visit and completing the required assessments and procedures.
- Receiving infusions of the investigational study drug.
- Telling the study doctor if you notice any changes to your health.
- Recording your medications you take, side effects, fevers, days of work missed, antibiotics taken, hospitalizations, and visits to other health care providers.
- Talking with the study doctor before changing current medications or starting new medications. This also includes new prescription medicines, over the counter medicines, vitamins, supplements, and vaccines.
- Telling the study doctor and study team if you want to stop participating in the study.
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