Bortezomib and thalidomide for the first‑line treatment of multiple myeloma | Guidance and guidelines

Documents

A list of downloadable documents created during development.

Background information

Multiple myeloma (first line) - bortezomib and thalidomide: review decision April 2015 information
Multiple myeloma (first line) - bortezomib and thalidomide: appendix A - GE decision paper - March 2015 08 April 2014 182.28 KB
Multiple myeloma (first line) - bortezomib and thalidomide: review proposal - January 2015 information
Multiple myeloma (first line) - bortezomib and thalidomide: appendix A - matrix of stakeholders 19 January 2015 100.25 KB
Multiple myeloma (first line) - bortezomib and thalidomide: appendix B - GE proposal paper January 2015 19 January 2015 317.91 KB

Multiple myeloma (first line) - bortezomib and thalidomide: equality impact assessment

Multiple myeloma (first line) - bortezomib and thalidomide: equality impact assessment 27 July 2011 68.98 KB

Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination (post appeal)

Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination (post appeal) information
Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination document 17 June 2011 254.66 KB
Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination - appeal decision 17 June 2011 102.77 KB
Consultee and commentator comments on the economic model from Janssen-Cilag 17 June 2011 222.03 KB
Response to consultee and commentator comments on the economic model 17 June 2011 235.27 KB

Multiple myeloma (first line) - bortezomib and thalidomide: appeal

Multiple myeloma (first line) - bortezomib and thalidomide: appeal information
Multiple myeloma (first line) - bortezomib and thalidomide: appeal decision 12 January 2011 115.22 KB
Multiple myeloma (first line) - bortezomib and thalidomide: notice of appeal information
Multiple myeloma (first line) - bortezomib and thalidomide: appeal registration information
Multiple myeloma (first line) - bortezomib and thalidomide: appeal announcement information
Multiple myeloma (first line) - bortezomib and thalidomide: appeal received 15 November 2010 531.09 KB
Multiple myeloma (first line) - bortezomib and thalidomide: initial scrutiny letter 15 November 2010 46.52 KB
Multiple myeloma (first line) - bortezomib and thalidomide: response to scrutiny letter 15 November 2010 187.11 KB
Multiple myeloma (first line) - bortezomib and thalidomide: final scrutiny letter 15 November 2010 25.49 KB

Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination

Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination information
Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination 26 August 2010 206.75 KB
Multiple myeloma (first line) - bortezomib and thalidomide: response to comments table 26 August 2010 304.92 KB
Multiple myeloma (first line) - bortezomib and thalidomide: consultee and commentator comments on the ACD
Multiple myeloma (first line) - bortezomib and thalidomide: manufacturer comments
Multiple myeloma (first line) - bortezomib and thalidomide: Janssen-Cilag
Multiple myeloma (first line) - bortezomib and thalidomide: Janssen-Cilag response 26 August 2010 619.61 KB
Multiple myeloma (first line) - bortezomib and thalidomide: Janssen-Cilag additional analyses 26 August 2010 307.22 KB
Multiple myeloma (first line) - bortezomib and thalidomide: Janssen-Cilag comments table 26 August 2010 308.03 KB
Multiple myeloma (first line) - bortezomib and thalidomide: Celgene response 26 August 2010 186.02 KB
Multiple myeloma (first line) - bortezomib and thalidomide: patient and professional groups
Multiple myeloma (first line) - bortezomib and thalidomide: Leukaemia CARE response 26 August 2010 34.37 KB
Multiple myeloma (first line) - bortezomib and thalidomide: Myeloma UK response 26 August 2010 82.31 KB
Multiple myeloma (first line) - bortezomib and thalidomide: British Society for Haematology & Royal College of Pathologists (joint submission) response 26 August 2010 90.88 KB
Multiple myeloma (first line) - bortezomib and thalidomide: Royal College of Nursing response 26 August 2010 63.32 KB
Multiple myeloma (first line) - bortezomib and thalidomide: Royal College of Physicians/NCRI/RCR/ACP/JCCO (joint submission) response 26 August 2010 79.94 KB
Multiple myeloma (first line) - bortezomib and thalidomide: UK Myeloma Forum response 26 August 2010 41.12 KB
Multiple myeloma (first line) - bortezomib and thalidomide: commentator comments
Multiple myeloma (first line) - bortezomib and thalidomide: NHS Quality Improvement Scotland 26 August 2010 41.36 KB
Multiple myeloma (first line) - bortezomib and thalidomide: Clinical Trials Research Unit (CTRU), University of Leeds response 26 August 2010 60.4 KB
Multiple myeloma (first line) - bortezomib and thalidomide: Southampton Health Technology Assessment Centre, University of Southampton response 26 August 2010 57.66 KB

Multiple myeloma (first line)- bortezomib and thalidomide: appraisal consultation

Multiple myeloma (first line)- bortezomib and thalidomide: appraisal consultation
Multiple myeloma (first line)- bortezomib and thalidomide: appraisal consultation document information
Multiple myeloma (first line)- bortezomib and thalidomide: evaluation report
Overview 02 June 2010 327.01 KB
Assessment report
Assessment report 02 June 2010 1.95 MB
Response to consultee and commentator comments on the assessment report 02 June 2010 35.9 KB
Consultee and commentator comments on the assessment report
Celgene 02 June 2010 27.26 KB
Janssen Cilag 02 June 2010 94.67 KB
Leukaemia Care 02 June 2010 59.2 KB
MRC Trial Management Group 02 June 2010 24.72 KB
Myeloma UK 02 June 2010 36.56 KB
NHS Quality Improvement Scotland 02 June 2010 25.85 KB
Royal College of Pathologists 02 June 2010 56.55 KB
Royal College of Physicians (NCRI/RCP/RCR/ACP/JCCO) 02 June 2010 40.04 KB
UK Myeloma Forum 02 June 2010 26.57 KB
MMIX clarification request 02 June 2010 57.84 KB
Non-manufacturer submissions
Myeloma UK (Supported by Leukaemia CARE and Macmillan Cancer Support)
Myeloma UK (Supported by Leukaemia CARE and Macmillan Cancer Support) 02 June 2010 1.39 MB
Letter 1 supporting Myeloma UK statement 02 June 2010 28.3 KB
Letter 2 supporting Myeloma UK statement 02 June 2010 20.96 KB
Royal College of Physicians (NCRI/RCP/RCR/ACP/JCCO) 02 June 2010 53.48 KB
Royal College of Pathologists 02 June 2010 56.55 KB
UK Myeloma Forum 02 June 2010 49.97 KB
Manufacturer submissions
Celgene 02 June 2010 51.86 KB
Janssen Cilag 02 June 2010 110.25 KB

Multiple myeloma (first line) - bortezomib and thalidomide: protocol

Multiple myeloma (first line) - bortezomib and thalidomide: protocol 27 July 2009 104.7 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Institute's response to comments on the provisional matrix

Multiple myeloma (first line) - bortezomib and thalidomide: Institute's response to comments on the provisional matrix 30 June 2009 15.63 KB

Multiple myeloma (first line) - bortezomib and thalidomide: final scope

Multiple myeloma (first line) - bortezomib and thalidomide: final scope 30 June 2009 42.42 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Institute's response to comments on the draft scope

Multiple myeloma (first line) - bortezomib and thalidomide: Institute's response to comments on the draft scope 30 June 2009 122.21 KB

Background information

Multiple myeloma (first line) - bortezomib and thalidomide: appendix A - GE decision paper - March 2015 08 April 2014 182.28 KB

Multiple myeloma (first line) - bortezomib and thalidomide: appendix A - matrix of stakeholders 19 January 2015 100.25 KB

Multiple myeloma (first line) - bortezomib and thalidomide: appendix B - GE proposal paper January 2015 19 January 2015 317.91 KB

Multiple myeloma (first line) - bortezomib and thalidomide: equality impact assessment

Multiple myeloma (first line) - bortezomib and thalidomide: equality impact assessment 27 July 2011 68.98 KB

Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination (post appeal)

Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination document 17 June 2011 254.66 KB

Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination - appeal decision 17 June 2011 102.77 KB

Consultee and commentator comments on the economic model from Janssen-Cilag 17 June 2011 222.03 KB

Response to consultee and commentator comments on the economic model 17 June 2011 235.27 KB

Multiple myeloma (first line) - bortezomib and thalidomide: appeal

Multiple myeloma (first line) - bortezomib and thalidomide: appeal decision 12 January 2011 115.22 KB

Multiple myeloma (first line) - bortezomib and thalidomide: appeal received 15 November 2010 531.09 KB

Multiple myeloma (first line) - bortezomib and thalidomide: initial scrutiny letter 15 November 2010 46.52 KB

Multiple myeloma (first line) - bortezomib and thalidomide: response to scrutiny letter 15 November 2010 187.11 KB

Multiple myeloma (first line) - bortezomib and thalidomide: final scrutiny letter 15 November 2010 25.49 KB

Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination

Multiple myeloma (first line) - bortezomib and thalidomide: final appraisal determination 26 August 2010 206.75 KB

Multiple myeloma (first line) - bortezomib and thalidomide: response to comments table 26 August 2010 304.92 KB

Multiple myeloma (first line) - bortezomib and thalidomide: consultee and commentator comments on the ACD

Multiple myeloma (first line) - bortezomib and thalidomide: manufacturer comments

Multiple myeloma (first line) - bortezomib and thalidomide: Janssen-Cilag

Multiple myeloma (first line) - bortezomib and thalidomide: Janssen-Cilag response 26 August 2010 619.61 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Janssen-Cilag additional analyses 26 August 2010 307.22 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Janssen-Cilag comments table 26 August 2010 308.03 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Celgene response 26 August 2010 186.02 KB

Multiple myeloma (first line) - bortezomib and thalidomide: patient and professional groups

Multiple myeloma (first line) - bortezomib and thalidomide: Leukaemia CARE response 26 August 2010 34.37 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Myeloma UK response 26 August 2010 82.31 KB

Multiple myeloma (first line) - bortezomib and thalidomide: British Society for Haematology & Royal College of Pathologists (joint submission) response 26 August 2010 90.88 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Royal College of Nursing response 26 August 2010 63.32 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Royal College of Physicians/NCRI/RCR/ACP/JCCO (joint submission) response 26 August 2010 79.94 KB

Multiple myeloma (first line) - bortezomib and thalidomide: UK Myeloma Forum response 26 August 2010 41.12 KB

Multiple myeloma (first line) - bortezomib and thalidomide: commentator comments

Multiple myeloma (first line) - bortezomib and thalidomide: NHS Quality Improvement Scotland 26 August 2010 41.36 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Clinical Trials Research Unit (CTRU), University of Leeds response 26 August 2010 60.4 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Southampton Health Technology Assessment Centre, University of Southampton response 26 August 2010 57.66 KB

Multiple myeloma (first line)- bortezomib and thalidomide: appraisal consultation

Multiple myeloma (first line)- bortezomib and thalidomide: appraisal consultation

Multiple myeloma (first line)- bortezomib and thalidomide: evaluation report

Overview 02 June 2010 327.01 KB

Assessment report

Assessment report 02 June 2010 1.95 MB

Response to consultee and commentator comments on the assessment report 02 June 2010 35.9 KB

Consultee and commentator comments on the assessment report

Celgene 02 June 2010 27.26 KB

Janssen Cilag 02 June 2010 94.67 KB

Leukaemia Care 02 June 2010 59.2 KB

MRC Trial Management Group 02 June 2010 24.72 KB

Myeloma UK 02 June 2010 36.56 KB

NHS Quality Improvement Scotland 02 June 2010 25.85 KB

Royal College of Pathologists 02 June 2010 56.55 KB

Royal College of Physicians (NCRI/RCP/RCR/ACP/JCCO) 02 June 2010 40.04 KB

UK Myeloma Forum 02 June 2010 26.57 KB

MMIX clarification request 02 June 2010 57.84 KB

Non-manufacturer submissions

Myeloma UK (Supported by Leukaemia CARE and Macmillan Cancer Support)

Myeloma UK (Supported by Leukaemia CARE and Macmillan Cancer Support) 02 June 2010 1.39 MB

Letter 1 supporting Myeloma UK statement 02 June 2010 28.3 KB

Letter 2 supporting Myeloma UK statement 02 June 2010 20.96 KB

Royal College of Physicians (NCRI/RCP/RCR/ACP/JCCO) 02 June 2010 53.48 KB

Royal College of Pathologists 02 June 2010 56.55 KB

UK Myeloma Forum 02 June 2010 49.97 KB

Manufacturer submissions

Celgene 02 June 2010 51.86 KB

Janssen Cilag 02 June 2010 110.25 KB

Multiple myeloma (first line) - bortezomib and thalidomide: protocol

Multiple myeloma (first line) - bortezomib and thalidomide: protocol 27 July 2009 104.7 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Institute's response to comments on the provisional matrix

Multiple myeloma (first line) - bortezomib and thalidomide: Institute's response to comments on the provisional matrix 30 June 2009 15.63 KB

Multiple myeloma (first line) - bortezomib and thalidomide: final scope

Multiple myeloma (first line) - bortezomib and thalidomide: final scope 30 June 2009 42.42 KB

Multiple myeloma (first line) - bortezomib and thalidomide: Institute's response to comments on the draft scope

Multiple myeloma (first line) - bortezomib and thalidomide: Institute's response to comments on the draft scope 30 June 2009 122.21 KB