Summary Report and Cover Letter Memo

Dear TACL T2017-002 Study Investigator:

As investigators participating in a clinical trial using the investigational medicinal product (IMP) ixazomib, Millennium Pharmaceuticals has issued safety reports referenced in the memos found below.  The details of these adverse events/safety issues can be found in the "Detailed Individual SUSAR/CIOMS Report" page.  Each safety report has been independently reviewed and assessed by Dr. Terzah Horton (TACL Study Chair) and/or Dr. Eric Schafer (Vice-Chairs) for T2017-002 study.

WHAT THE INVESTIGATOR NEEDS TO DO WITH THIS INFORMATION:

• Review each external adverse event associated with the use of ixazomib as described in the T2017-002 Ixazomib External SUSAR summary report independent of study chair's determination
• Evaluate each external adverse event to determine if it meets your local IRB/IEC reporting requirements
• If Iocal IRB/IEC reporting requirements are met, submit it within the required timeframe 
• Even if local IRB/IEC reporting requirements are not met, submission may be necessary per TACL Study Chair's determination
• Copy and attach the summary reports to your Investigator's Brochure for the T2017-002 Ixazomib study protocol
• Retain a copy of the memos in your site's study regulatory files