Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1.

It is essential that there be consistency in the conduct, analysis, and reporting of clinical trial results in myeloma. The goal of the International Myeloma Workshop Consensus Panel 1 was to develop a set of guidelines for the uniform reporting of clinical trial results in myeloma. This paper provides a summary of the current response criteria in myeloma, detailed definitions for patient populations, lines of therapy, and specific endpoints. We propose that future clinical trials in myeloma follow the guidelines for reporting results proposed in this manuscript.

[1]  A. Dispenzieri,et al.  The importance of bone marrow examination in determining complete response to therapy in patients with multiple myeloma. , 2008, Blood.

[2]  R A Kyle,et al.  Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma , 2009, Leukemia.

[3]  D. Esseltine,et al.  The relationship between quality of response and clinical benefit for patients treated on the bortezomib arm of the international, randomized, phase 3 APEX trial in relapsed multiple myeloma , 2008, British journal of haematology.

[4]  Bin Jiang,et al.  Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. , 2008, The New England journal of medicine.

[5]  B. Durie,et al.  Eliminating the complete response penalty from myeloma response criteria. , 2008, Blood.

[6]  S. Lonial,et al.  Eliminating the complete response penalty from myeloma response assessment. , 2008, Blood.

[7]  P. Richardson,et al.  Clinically relevant end points and new drug approvals for myeloma , 2008, Leukemia.

[8]  B. Durie,et al.  Assessing response rates in clinical trials of treatment for relapsed or refractory multiple myeloma: a study of bortezomib and thalidomide by H Prince, Brad Schenkel and Linda Mileshkin , 2007, Leukemia.

[9]  L. Mileshkin,et al.  Assessing response rates in clinical trials of treatment for relapsed or refractory multiple myeloma: a study of bortezomib and thalidomide , 2007, Leukemia.

[10]  M. Minden,et al.  A phase II study of temozolomide therapy for poor-risk patients aged ⩾60 years with acute myeloid leukemia: low levels of MGMT predict for response , 2007, Leukemia.

[11]  D. Esseltine,et al.  Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study. , 2006, Blood.

[12]  B. Barlogie,et al.  International uniform response criteria for multiple myeloma , 2006, Leukemia.

[13]  B. Durie.  The role of anatomic and functional staging in myeloma: description of Durie/Salmon plus staging system. , 2006, European journal of cancer.

[14]  M. Gordon.  Bortezomib or High-Dose Dexamethasone for Relapsed Multiple Myeloma , 2006 .

[15]  Hartmut Goldschmidt,et al.  Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. , 2005, The New England journal of medicine.

[16]  Bart Barlogie,et al.  A phase 2 study of bortezomib in relapsed, refractory myeloma. , 2003, The New England journal of medicine.

[17]  S. Jagannath,et al.  CRITERIA FOR EVALUATING DISEASE RESPONSE AND PROGRESSION IN PATIENTS WITH MULTIPLE MYELOMA TREATED BY HIGH‐DOSE THERAPY AND HAEMOPOIETIC STEM CELL TRANSPLANTATION , 1998, British journal of haematology.

[18]  O. Cope,et al.  Multiple myeloma. , 1948, The New England journal of medicine.