Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients
Status:
Terminated
Trial end date:
2019-09-10
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to test whether the drug ibrutinib (trademark name:
IMBRUVICA®) is effective at preventing the development of multiple myeloma in people who
currently have smoldering myeloma. The researchers conducting this trial) have reason to
believe that ibrutinib can delay the development of multiple myeloma, thus giving people who
currently have smoldering myeloma a longer period of time when they feel healthy and well.
Smoldering myeloma is an abnormal condition that is considered to be an early phase of the
disease multiple myeloma. In this disorder, there is an abnormal growth of plasma cells,
which is a type of blood cell found in the bone marrow. This growth is not as severe in
people with smoldering myeloma as it is in multiple myeloma, so people with smoldering
myeloma do not have any symptoms and tend to feel well. However, they have a higher risk of
developing multiple myeloma than people in the general population.
Some people with smoldering myeloma are at an especially high risk of developing myeloma -
50% of these people will develop multiple myeloma 2 years after they are diagnosed with
smoldering myeloma. The investigators identify these people by looking at the amount of
myeloma in the bone marrow (called "bone marrow plasma cell percentage") and the amount of
myeloma protein (called "serum protein electrophoresis" and "serum free light chain assay")
in the blood. To be considered high risk, individuals must have highly abnormal levels for
these tests.
Based upon current guidelines, people with smoldering myeloma do not require any treatment.
However, known is that many of these people will develop multiple myeloma in the near future.
Currently there have been no proven and effective way of preventing these people from
developing multiple myeloma, which remains an incurable disease.