A multicenter, randomized phase III study of bortezomib and ...

HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012
pain not interfering with function (grade 1), then the bortezomib dose is given once per week and
reduced by 50%.
Dexamethasone
Known side effects are fluid retention, hypertension, stomach ulcer, hyperglycemia, psychological
disturbances like sleeplessness, mood changes and psychosis. If side effects occur related to
dexamethasone which cannot be managed with other interventions the dose must be reduced to 20
mg instead of 40 mg in the same treatment schedule. For patients in arm B also one dose reduction is
allowed from 20 mg to 10 mg (12 mg is allowed).The dose must also be reduced in case of signs of
cardiac failure defined as:
- 4% weight gain (of last known weight)
- 1 upgrade on NYHA scoring list (appendix E)
No further dose adjustments are allowed.
9.1.4 Supportive care during (bortezomib and) dexamethasone
Antibiotic prophylaxis is mandatory; the advice is to use ciprofloxacin 500 mg bid starting on
day 1 of treatment until 2 weeks after the last intake of treatment medication. Advice is NOT
to use co-trimoxazol profylaxis because of renal complications in AL amyloidosis patients.
Gastric acid production inhibition is mandatory, advise is to use a protonpump inhibitor
Herpes zoster prophylaxis is mandatory only when bortezomib is given, the advice is to use
Valacyclovir 500 mg bid or Acyclovir 200 mg 3 dd, starting on day 1 of bortezomib until 4
weeks after the last administration
Anti-fungal therapy is advised, advice is to use fluconazol 200 mg daily starting at the first
day of treatment until 2 weeks after the last intake of treatment medication
If symptomatic hypotension occurs during treatment it is advised to ensure adequate volume
repletion and start of anti-hypotensive drugs like fludrocortisone or midodrine (see also 9.1.3,
non-hematological toxicities).
9.2 Stem cell mobilization
After 3 or 4 courses of bortezomib and dexamethasone or dexamethasone alone all patients who
meet the eligibility criteria for stem cell collection and HDM with auto-SCT (see 8.2), continue with
stem cell mobilization.
Patients who do not meet the eligibility criteria will go off-protocol treatment
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