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 There is reason to conclude that it will not be possible to collect the data necessary to reach the study objectives and it is therefore not ethical to continue enrolment of more patients; for example insufficient enrolment that cannot be improved. The DSMB recommends to end the trial based on viable arguments other than described above The sponsor will promptly notify all concerned investigators, the Ethics Committee(s) and the regulatory authorities of the decision to terminate the study. The sponsor will provide information regarding the time lines of study termination and instructions regarding treatment and data collection of enrolled patients. 12 Safety 12.1 Definitions Adverse event (AE) An adverse event (AE) is any untoward medical occurrence in a patient or clinical study subject during protocol treatment. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Serious adverse event (SAE) A serious adverse event is defined as any untoward medical occurrence that at any dose results in: Death A life-threatening event (i.e. the patient was at immediate risk of death at the time the reaction was observed) Hospitalization or prolongation of hospitalization Significant / persistent disability A congenital anomaly / birth defect Any other medically important condition (i.e. important adverse reactions that are not immediately life threatening or do not result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed above, including suspected transmission of infectious agents by a medicinal product.) Note that ANY death, whether due to side effects of the treatment or due to progressive disease or due to other causes is considered as a serious adverse event. Page 34 of 75 EudraCT-No: 2010-021445-42
HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012 Suspected unexpected serious adverse reaction (SUSAR) All suspected Adverse Reactions which occur in the trial and that are both unexpected and serious. Suspected adverse reactions (AR) are those Aes of which a reasonable causal relationship to any dose administered of the investigational medicinal product and the event is suspected. Unexpected adverse reactions are adverse reactions, of which the nature, or severity, is not consistent with the applicable product information (e.g. Investigator’s Brochure for an unapproved IMP or Summary of Product Characteristics (SPC) for an authorised medicinal product). 12.2 Adverse event 12.2.1 Reporting of adverse events Adverse events will be reported from the first study-related procedure until 30 days following the last dose of any drug from the protocol treatment schedule or until the start of subsequent systemic therapy for the disease under study, if earlier. Adverse events occurring after 30 days should also be reported if considered at least possibly related to the investigational medicinal product by the investigator. Adverse Events have to be reported on the Adverse Events CRF. Adverse Events will be scored according to the NCI Common Terminology Criteria for Adverse Events, version 4.0 (see appendix D). Pre-existing conditions will be collected on the baseline concomitant diseases CRF, i.e. active (symptomatic) diseases of CTCAE grade 2, diseases under treatment, chronic diseases and long term effects of past events as present at the time of baseline assessment. All Adverse Events have to be reported, with the exception of: 1. A pre-existing condition that does not increase in severity; the pre-existing condition should be reported on the baseline concomitant diseases CRF 2. AE’s of CTCAE grade 1 3. Abnormal laboratory values that have been recorded as being not clinically significant by the investigator in the source documents 4. Progression of the disease under study; complaints and complications as a result of disease progression remain reportable Adverse Events 5. Nausea/vomiting of CTCAE grade 3 or less occurring during or within 14 days after high dose melphalan treatment 6. Hematological toxicity of CTCAE grade 3 or less occurring during or within 14 days after high dose melphalan treatment Page 35 of 75 EudraCT-No: 2010-021445-42
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