Links to the current protocol, patient information sheet, patient informed consent form, donor information sheet and donor informed consent form are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.
Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines etc.) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the LenaRIC Trial Office.
- Protocol version 6.0 19-Nov-13 [.pdf]
- Patient Information Sheet version 6.0 19-Nov-13 [.doc]
- Patient Informed Consent Form version 6.0 19-Nov-13 [.doc]
- Donor Information Sheet version 5.0 07-May-13 [.doc]
- Donor Informed Consent Form version 5.0 07-May-13 [.doc]
Version Control Lists
The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Version Control Lists used in this trial are below in reverse date order.
Version Control Checklist - Investigator Site File 6.0 19-Nov-13 [.pdf]
Version Control Checklist - Investigator Site File 5.0 07-May-13 [.pdf]
Version Control Checklist - Investigator Site File 4.0 01-Mar-12 [.pdf]
Version Control Checklist - Investigator Site File 3.0 18-Apr-11 [.pdf]
Version Control Checklist - Investigator Site File 2.0 20-Oct-10 [.pdf]
Version Control Checklist - Investigator Site File 6.0 19-Nov-13 [.pdf]
Version Control Checklist - Investigator Site File 5.0 07-May-13 [.pdf]
Version Control Checklist - Investigator Site File 4.0 01-Mar-12 [.pdf]
Version Control Checklist - Investigator Site File 3.0 18-Apr-11 [.pdf]
Version Control Checklist - Investigator Site File 2.0 20-Oct-10 [.pdf]
Version Control Checklist - Investigator Site File 1.0 02-Jul-10 [.pdf]
Amendments
The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.
Amendment 01 [opens new page]
Amendment 02 [opens new page]
Amendment 03 [opens new page]
Amendment 04 [opens new page]
Amendment 05 [opens new page]
Amendment 06 [opens new page]
Amendment 07 [opens new page]
Case Report Forms
Current Case Report Forms:
Registration Form [.pdf]
Eligibility Checklist [.pdf]
Myeloma History Form [.pdf]
Screening pre-transplant assessment form [.pdf]
Transplant Form [.pdf]
Pre-Lenalidomide assessment form [.pdf]
Month 1 post-transplant form [.pdf]
Month 2 post-transplant form [.pdf]
Month 3 post-transplant form [.pdf]
Months 4-6 post-transplant form [.pdf]
Months 7-9 post-transplant form [.pdf]
Months 10-12 post-transplant form [.pdf]
Month 15 post transplant form [.pdf]
Month 18 post transplant form [.pdf]
Month 21 post transplant form [.pdf]
Month 24 post transplant form [.pdf]
Cycles 1 - 3 of treatment Form [.pdf]
Cycles 4-6 of treatment Form [.pdf]
Cycles 7-9 of treatment Form [.pdf]
Cycles 10-12 of treatment Form [.pdf]
Adverse event form [.pdf]
Concomitant medication form [.pdf]
Immune reconstitution form [.pdf]
GvHD form [.pdf]
End of study form [.pdf]
Progressive disease notification form [.pdf]
Patient withdrawal of consent form [.pdf]
Treatment discontinuation form [.pdf]
Deviation form [.pdf]
Death form [.pdf]
SAE form [.pdf]
SAE Concomitant medication form [.pdf]
Pregnancy Notification Form [.pdf]
Guidelines
- CRF Completion Guidelines [.doc]
- SAE Form Completion Guidelines [.doc]
Other Trial Documents
- Pharmacy Manual [.pdf]
- SAE Fax Cover Sheet [.doc]