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 9.4.2 Preparation and labeling Bortezomib will be shipped to trial sites in containers labeled as an Investigational Medicinal Product. Bortezomib will be prepared and labeled in compliance with GMP and other applicable regulatory requirements. 9.4.3 Storage and handling Bortezomib should be stored and handled in accordance with the instructions in the summary of product characteristics or package insert. The investigational medicinal product should be stored in such a manner that accidental loss or destruction or access by an unauthorized person is prevented. 9.4.4 Study drug supply The sponsor will arrange delivery of bortezomib to trial sites. No investigational medicinal product will be shipped until the sponsor has verified that all regulatory required documents and approvals for the site are available. 9.4.5 Drug accountability The investigator, or a pharmacist or other appropriate individual who is designated by the investigator, should maintain records of the product's delivery to the trial site, the inventory at the site, the use by each patient, and the return to the sponsor or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial patients (if applicable). Investigators should maintain records that document adequately that the patients were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor. 9.4.6 Study drug return and destruction Partially used investigational medicinal product should not be redispensed to either the same or another patient after it has been returned. The trial site should destroy used or partially used study drug containers after drug accountability records have been completed. Destruction should be documented. Unused investigational medicinal product should be retained until the sponsor has instructed the investigator on the return or destruction of the product. Page 26 of 75 EudraCT-No: 2010-021445-42
HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012 10 Study procedures 10.1 Time of clinical evaluations At entry: within 2 weeks before registration and before start of treatment Importantly, bone marrow aspirates and biopsies taken within 4 weeks before inclusion are valid as entry evaluations and do not have to be repeated. This also applies to echocardiography and X-ray or low dose CT / MRI of the whole body but not for other required evaluations. A separate informed consent is available in which a patient can consent to the extra bone marrow aspirate volume of 3.5 ml needed for the MRD study. This aspirate has to be sent to a central lab (see appendix I) If a patient consents to the experimental fat aspiration side study this has to be performed after informed consent and before start of study medication or a patient can consent to take extra material during diagnostic work up with the separate infomed consent and send this to a central lab (see appendix J). All evaluations have to be done before start of treatment. After each induction cycle. After stem cell mobilisation and before HDM At 3 months after date of auto-SCT At 6 months after date of auto-SCT. This evaluation is the primary endpoint of the study and has to be combined with bone marrow examination (+ MRD analysis), echocardiography and ECG analysis. However if a bone marrow examination was performed earlier in the treatment schedule because a CHR was suspected and confirmed, and no signs of relapse (Appendix B) are established a patient is considered to be in continious CHR and a bone marrow examination does not have to be repeated at 6 months. During follow up every 3 months, calculated from the date of auto-SCT (or date off protocol treatment). The follow up evaluation may be done between 2 weeks before or 2 weeks after the 3- monthly evaluation date. Suspected CHR: If serum and urine IF becomes negative and FLC ratio normal a bone marrow examination has to be performed to establish CHR. All patients will be followed until 5 years after registration. Page 27 of 75 EudraCT-No: 2010-021445-42
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Page 71 and 72: Appendix J HOVON 104 AL AMYLOIDOSIS
Page 73 and 74: Appendix J HOVON 104 AL AMYLOIDOSIS
Page 75: Appendix L HOVON 104 AL AMYLOIDOSIS

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