A Phase 2/3 Clinical Study for People With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Deciding whether to join a clinical study is a big decision. You will want to gather as much information as possible and talk with your doctor 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 MM5 study?

The official title of this study is:

A Phase 2/3, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma.

It is also referred to as Protocol C16029.

What is the goal of the study?

To learn whether ixazomib in combination with dexamethasone controls multiple myeloma longer than pomalidomide in combination with dexamethasone in patients with Relapsed Refractory Multiple Myeloma whose disease is resistant to lenalidomide but should be sensitive to proteasome inhibitors. The study is for patients who have already received at least two lines of therapy, including lenalidomide and a proteasome inhibitor, and are resistant to lenalidomide but not resistant to proteasome inhibitors.

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

There are two study groups. Once enrolled in the study, you will be randomly selected to receive one of the study treatments below:

Ixazomib combined with dexamethasone or Pomalidomide combined with dexamethasone

What will researchers be measuring in this study?

Every study has something called a primary endpoint. This helps researchers understand if the study treatment has 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 study treatment that a person lives with multiple myeloma 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:

  • Overall survival (OS)
  • Overall response rate (ORR)
  • Duration of response
  • Time to response
  • Time to progression (TPP)
  • Health-related Quality of life (QOL) related to physical functioning
  • Health-related QOL related to additional function and symptom domains
  • Health care utilization (HU)
  • Safety

How many patients will participate in this study?

About 300 patients will participate if the study continues to the next stage/phase.

How long will the study last?

Up to 63 months if the phase 3 portion is completed.

What should I know about Ixazomib?

Ixazomib is an oral proteasome inhibitor. A proteasome inhibitor is a type of medication that targets the proteasomes inside cells. In this study, ixazomib is being used to study a new use in combination with drug called dexamethasone. It is the first oral proteasome inhibitor to enter clinical trials for patients. Ixazomib is approved in the US, EU, Australia, Japan and some other countries in combination with lenalidomide and dexamethasone for multiple myeloma patients who have had at least one prior therapy.

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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