LenaRIC

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. 

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Delegation Log [.pdf]

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]

1. Cook M, Panchal A, Brock K, McQuaker G, Snowden JA, Crawley CR, Hunter H, Cavenagh JD, Sirovica M, Hodgkinson A and Cook G. Reduced Intensity Stem Cell Transplantation Followed By Adjunctive Lenalidomide Is Tolerable and Safe and Improves Complete Response Rate in Multiple Myeloma:a UK NCRI Phase 2 Feasibility Study (LenaRIC). Blood 2017 130:3308

2. Cook G, Carter CR, Brock K, McQuaker G, Snowden JA, Crawley C, Hunter H, Cavenagh JD,  Lobb M, Cullen K, Hodgkinson A, Sirovica M and Cook M. Immune Biomarkers Identify Sustained Quantitative and Functional Immune Reconstitution in the Setting of Adjunctive Lenalidomide Following T-Depleted RIC-Allo SCT for Multiple Myeloma. Blood 2016 128:4585

None at present

Chief Investigator

Dr Mark Cook
Consultant Haematologist
Centre for Clinical Haematology
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom

LenaRIC Trial Office
Trial Coordinator: Mohamed Elhaneid
Trial Administrator: John Mason
Trial Management Team Leader: Shamyla Siddique

Centre for Clinical Haematology
Research Office
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH

Enquiries
Tel: 0121 371 4365
Fax: 0121 371 4398
Email: LenaRIC@trials.bham.ac.uk

Serious Adverse Event Reporting
Fax: 0121 371 4398

Sponsor

University Hospitals Birmingham NHS Foundation Trust

Correspondence to:
Dr Christopher Counsell (Sponsor representative)
Research & Development
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital Birmingham
Mindelsohn Way
Edgbaston
Birmingham
B15 2WB