A Phase 3 Clinical Study for People With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

Deciding whether to join a clinical study is a big decision. You will want to gather as much information as possible before you make your decision. Below are answers to some key questions designed to give you a better understanding of the study and its goals. You can also visit ClinicalTrials.gov for more information.

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What is the official title of the Tourmaline MM4 study?

The official title of this study is:

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation.

It is also referred to as Protocol C16021.

What is the goal of the study?

To determine whether investigational ixazomib maintenance therapy improves survival in patients with newly diagnosed multiple myeloma who have had a major response to initial therapy and who have not had a stem cell transplant.

What are the possible study groups that I could be assigned to in this study?

There are 2 study groups in this study. If you are eligible and you choose to participate, you will be selected at random to receive either:

Ixazomib OR Placebo

What will researchers be measuring in this study?

Every study has a primary endpoint, or the main result that is measured at the end of the study to see if the treatment worked.

In this study, the primary endpoint that researchers will be looking at is progression-free survival (PFS). This refers to the length of time during and after the treatment that the disease remains stable and does not get worse.

In addition to the primary endpoint, there are secondary endpoints. These are results that are measured at the end of a study and contribute to the understanding of the study data. Some secondary endpoints include:

  • Safety
  • Overall survival (OS)
  • Best response
  • Time to progression (TTP)
  • Second progression free survival (PFS2)

How many patients will participate in this study?

Approximately 761 patients will participate in this study.

How long will the study last?

The duration of treatment will be approximately 24 months, but the study follow-up will be for up to 7 years.

What should I know about Ixazomib?

Ixazomib is an investigational, oral proteasome inhibitor. It is the first oral proteasome inhibitor to enter clinical trials for patients. Ixazomib is a prescription medicine used to treat multiple myeloma in combination with the medicines lenalidomide and dexamethasone, in people who have received at least one prior treatment for their multiple myeloma.

To learn more about this clinical study, visit ClinicalTrials.gov
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