A multicenter, randomized phase III study of bortezomib and ...
A multicenter, randomized phase III study of bortezomib and ...
A multicenter, randomized phase III study of bortezomib and ...
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HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012<br />
1 Scheme <strong>of</strong> <strong>study</strong><br />
Newly diagnosed AL Amyloidosis, age 18-70 years inclusive<br />
Arm A<br />
Induction<br />
R<br />
1 : 2<br />
Arm B<br />
3 cycles q 4 weeks<br />
Dexamethasone 40 mg<br />
days 1-4, 9-12 <strong>and</strong> 17-20<br />
4 cycles, q 3 weeks<br />
Bortezomib 1.3 mg/m 2 ,<br />
days 1,4,8,11<br />
Dexamethasone 20 mg<br />
days 1-2, 4-5, 8-9, 11-12<br />
Eligible for<br />
stem cell mobilization<br />
no<br />
Off protocol<br />
treatment<br />
yes<br />
Stem cell mobilization with<br />
G-CSF<br />
Eligible for<br />
HDM with auto-SCT<br />
no<br />
Off protocol<br />
treatment<br />
yes<br />
High Dose Melphalan with autologous<br />
Stem Cell Transplantation<br />
Off protocol<br />
treatment<br />
Page 4 <strong>of</strong> 75 EudraCT-No: 2010-021445-42
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