Takeda initiates INSIGHT-MM global observational study of patients with multiple myeloma.

Takeda Pharmaceutical Company Limited announced that its global non-interventional, observational multiple myeloma study is now enrolling patients. Titled INSIGHT-MM , the study aims to enroll 5,000 patients over three years with a goal of following each patient for a minimum of five years in an effort to track patterns in disease presentation, patient characteristics, treatment and outcomes and thereby enhance the understanding of real world experience of patients with multiple myeloma.

Led by an international steering committee of myeloma experts, the INSIGHT-MM study will gather data via routine office visits, medical records and patient self-reported outcomes. Participation in INSIGHT-MM, a non-interventional study, will not determine or alter patients� treatment; rather, patients will receive their usual therapy as determined by their healthcare provider during the course of their care. Designed to be collaborative, INSIGHT-MM remains open for the multiple myeloma community to propose analyses and request data that has been collected during the study.-An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients (INSIGHT-MM)-(2016)-ClinicalTrials.gov Identifier: NCT02761187.

Comment: Ninlaro (ixazomib) was approved by regulatory agencies in the US and Canada but received a negative opinion from the CHMP in Europe as its application did not show that the drug was more effective in more difficult to treat disease.It also faces competition from generic Velcade next year and carries a high price though its oral delivery may be more acceptable to patients than injectable Velcade.