Summary of Changes
- Change of consolidation treatment for patients with poor risk localised disease to 1 cycle VAI plus BuMel (for both arms A and B).
- Addition of IMPs busulfan and melphalan
- Addition to the exclusion criteria for the second randomisation (R2) of a history of jaw fracture
- Minor changes to wording and terminology used for the purposes of clarity
- Updated personnel contact detials, change of phone number for emergency randomisation and change of fax number for SAE reporting
- Clarification of time-points for blood samples for biological studies
MHRA approval [.pdf]
MHRA cover letter [.pdf]
REC favourable opinion [.pdf]
REC cover letter [.pdf]
Notification of a substantial amendment [.pdf]