Clinical Trial: Further Insight on INSIGHT Myeloma Observational Clinical Trial

By Jim Omel MD, INSIGHT Steering Committee Member Takeda Oncology’s INSIGHT trial for both newly diagnosed and relapsed myeloma patients continues to make steady progress.   Prospective observational studies such as this have the potential to address critical questions on real-world multiple myeloma outcomes.  Understanding availability and effectiveness of so many new treatment regimens for myeloma is critically important, especially when viewed on a world-wide basis.  Very early data were presented at ASH17, and at a recent scheduled Interim Analysis the data’s accuracy and consistency were verified.  Background information described in an ASH abstract explained that patients treated outside of clinical trials show markedly shorter progression free survival of 11 months for Newly Diagnosed and 7-10 months for patients with Relapsed/Refractory disease (Jagannath, Expert Rev Hematol 2016). INSIGHT’s initial goal was to enroll 5000 adult patients from 15 countries and follow them prospectively for 5 years.  Accrual has closely followed initial expectations, and the Steering Committee was pleased to confirm that most CRFs (case report forms) are being completed by study sites as expected.   As analysis continues it is apparent that there is no global standard for treatment of multiple myeloma whether newly diagnosed or relapsed/refractory. While there can be significant country to country variability, it is noted that Velcade-based therapy is the most commonly used globally.  The most frequent regimens are VCD (Velcade Cytoxan dex), VRD (Velcade Revlimid dex), VD (Velcade dex), and VTD (Velcade Thalidomide dex).  In the USA the most commonly used triplet regimen for newly diagnosed patients is VRD.  Triplets dominate over doublets in front line setting by a nearly 3 to 1 ratio. Fully 85% of myeloma patients are treated outside of established clinical trials.  INSIGHT will be very useful in capturing outcome data for these thousands of individuals whose data would otherwise be unknown and therefore not helpful in advancing our collective knowledge about successfully treating myeloma. Several publications are expected to derive from this important ongoing study.  If you are a newly diagnosed myeloma patient (within 3 months of initiation of therapy) or a relapsed/refractory myeloma patient (with 1-3 lines of prior therapy) please consider joining this study to add your data to thousands of others.  Please ask your doctor if his/her institution is participating and whether you are eligible to join.  Click the button below to find all study locations. INSIGHT Clinical Trial