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

HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012
There is no set time limit for the patient to make a decision. The physician should inform each patient
if there is a specific reason why he/she must decide within a limited time frame, for example if patients
condition necessitates start of treatment or if the trial is scheduled to close for enrolment.
(*country specific adaption for GERMANY: The informed consent procedure will be performed by an
investigator (approved by the EC) without a treatment relationship with the patient.)
The content of the patient information letter, informed consent form and any other written information
to be provided to patients will be in compliance with ICH-GCP and other applicable regulations and
should be approved by the Ethics Committee in advance of use.
The patient information letter, informed consent form and any other written information to be provided
to patients will be revised whenever important new information becomes available that may be
relevant to the patient’s consent. Any revised informed consent form and written information should
be approved by the Ethics Committee in advance of use. The patient should be informed in a timely
manner if new information becomes available that might be relevant to the patient’s willingness to
continue participation in the trial. The communication of this information should be documented.
17.4 Benefits and risks assessment.
Most analyses in the trial are considered normal patient care and therefore the burden of participation
is minimal. Patients participating in the trial will undergo 3 additional 24 hour collection of urine
analysis, additional 2 (in total 7) echocardiographies and 1 additional bone marrow analysis 6 months
after auto-SCT. The risks associated with the investigational product mostly consist of:
non-hematological toxicity like development of peripheral sensory neuropathy with or without
neuropathic pain, orthostatic hypotension, peripheral edema, hyopnatriemia, worsening of congestive
heart failure, fatique, constipation or diarrhea and nausea. 11;14 Hematological toxicity is mainly
reversible thrombocytopenia.
The benefits for participating in the trial is close monitoring of the patients condition which is very
important in these fragile patients and access to a drug not registered for this condition but with very
promising results in clinical studies.
17.5 Trial insurance
Prior to the start of the trial, the sponsor will ensure that adequate insurance for patients is in place
covering losses due to death or injury resulting from the trial, in accordance with applicable laws and
regulations in each country where the trial is conducted. The sponsor will take out an insurance policy
or delegate this responsibility to a national co-sponsor. Proof of insurance will be submitted to the
Ethics Committee.
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