Myeloma represents less than 1% of all cancer cases globally and within the community multiple myeloma represents the second most common blood cancer.
This study is looking for adult individuals (at least 18 years-old) who have RRMM (this means that your myeloma has returned).
What is the purpose of the study?
What are the investigational medication and injector device?
What is a clinical research study?
Clinical research studies are used to show if/how an investigational medication works and to find out if it is safe. They can also be referred to as clinical trials.
Clinical studies are run by qualified healthcare professionals. The doctors and other healthcare providers are responsible for the study-related care of the people that participate (or enroll) in these studies. Clinical trials are a mandatory part of the process that leads to an approval, which is required before a drug can be marketed.
Independent committees (called Institutional Review Boards or IRBs) are made up of medical and non-medical people, who also watch over clinical research studies, to make sure that the people who enroll are properly and adequately informed and consent prior to study participation.
Why are clinical trials conducted?
Clinical trials are essential to the development of new interventions (drugs, vaccines, procedures, devices) that help people to live longer and with less pain or disability.
They help researchers to understand what does and doesn’t work in humans that cannot be learned in the laboratory or in animals. Clinical trials also help doctors decide if the side effects of an investigational treatment are acceptable when weighed against the potential benefits.
How do clinical trials work?
Clinical trials must adhere to Good Clinical Practices (GCP), rigid standards that clearly state what is allowed by medical professionals during a clinical trial.
Clinical trials follow rigid and specific testing procedures designed to help researchers determine the safety and effectiveness of the investigational drug or medical treatment being studied.
Why should I join a clinical research study?
Thousands of people volunteer to participate in clinical trials every year. The reasons for participation vary, but all of them help to advance medicine. Some reasons include:
Who can participate in a study?
Every clinical trial has a set of criteria that study participants must meet in order to participate, including agreeing to sign an informed consent form and HIPAA (Health Insurance Portability and Accountability Act) authorization.
What is an informed consent?
What is an open label study?
Both the study participant and study doctor will know the treatment assignment.
What is a Phase III (Phase 3) trial?
Researchers compare the investigational medication with the current standard treatment or placebo. They monitor any side effects very closely. Larger groups of patients (typically several hundred to thousands of people) participate in different Phase 3 clinical trials. These studies can take many years to complete and are often completed in many different locations.
The purpose of a Phase 3 trial is to determine whether the investigational medication is safe and if it has a therapeutic (beneficial) effect.
In most cases, a study participant and study doctor will not know whether they have received the investigational medication, an existing treatment, or placebo. This helps minimize any bias.
What type of study-related medical care is provided during the study?
All study-related medical care related to the study is provided, including study-related exams, study-related medications and other study-related medical care. There is no insurance required to participate. All study-related medical care will be explained.
Studies may also offer compensation in return for travel.
Is it safe to participate in a clinical trial?
All clinical trials have possible risks, some of which are known before the study starts. Before deciding to participate, the study risks will be explained. Study participants are closely monitored during the study.
While side effects may occur with any investigational medication being studied, the safety and well-being of study participants are top priorities for the sponsors, doctors, nurses and research professionals who conduct clinical trials.
Study participants can decide at any point to end participation.
What about clinical trials participation during COVID-19?
This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19. Each individual site location will review their protocols including mask wearing, social distance, pre-appointment check in. Study sites are medical facilities where COVID safety procedures are followed.
The COVID-19 vaccine can be administered before entering in the study or afterwards, without needing study drug interruption. This should be discussed with your study doctor.
Can I speak with someone if I have questions?
Yes, after you complete the online questionnaire and give permission to be contacted, a study representative will contact with you. You can ask questions at any time, before deciding to participate and during study conduct.
Complete this brief questionnaire (approximately 5-10 minutes) to determine if you may be eligible to participate in this clinical study and be referred to a site recruiting in your area.
References: 1-International Agency for Research on Cancer. Fact sheets by population. GLOBOCAN 2012; 2-Multiple myeloma: an overview/Prof. Parameswaran Hari/Medical College of Wisconsin, US.