Summary of Changes
- Removal of randomisations to Busulfan and Melphalan. (R2loc and R2pulm).
- Renaming of R2zol as R2 VAC, R2 VAI and R2 IEVC
- Amendment to eligibility criteria for R2
- Reduction in recruitment target for R2
- Change of treatment for Arm A patients (localised disease) from 1 cycle VAI plus 7 cycles VAC to 8 cycles VAC
- Change in number of bone marrow aspirate assessments from 4 to 1
- Amended length of time contraception is required for males patients post treatment Inclusion of treatment guidance for hypocalcaemia
- Removal of reference to Chemotherapy Guidelines
- Inclusion of central pathology review Clarification of details for biological studies
- Renumbering of Appendices and inclusion of a new Appendix 1: Country specific quality and trial management plan
- Minor changes to wording and terminology used in other sections for the purposes of clarity, especially with regard to international coordinating centre
MHRA Approval letter [.pdf]
Rec Favourable Opinion [.pdf]
Notification of a Substantial Amendment Form [.pdf]
ARSAC PRA Form [.pdf]