We are international
Donate
• treatment options TEXT SIZE   
imwg guidelines    back

International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
04.21.10

International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma1

The International Myeloma Working Group established the below criteria in order to:

  • facilitate precise comparisons of efficacy between new treatment strategies in trials
  • incorporate the serum free light chain (FLC) assay to include assessment of patients with oligo-secretory and non-secretory disease
  • provide stricter definitions for CR (complete response)
  • provide classifications that would improve detail and correct inconsistencies in prior response criteria.

The following criteria reconcile various previously used systems for assessing response and have been universally adopted.

Response

IMWG criteria

sCR

CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow3 by immunohistochemistry or immunofluorescence4

CR

Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow3

VGPR

Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h

PR

> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h

If the serum and urine M-protein are unmeasurable,5 a > 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria

If serum and urine M-protein are not measurable, and serum free light assay is also not measureable, > 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was > 30%

In addition to the above listed criteria, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required

MR

NA

No change/Stable disease

Not meeting criteria for CR, VGPR, PR, or progressive disease

Plateau

NA

Progressive disease5

Increase of > 25% from lowest response value in any one or more of the following:

  • Serum M-component and/or (the absolute increase must be > 0.5 g/dL)6
  • Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
  • Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL
  • Bone marrow plasma cell percentage; the absolute percentage must be > 10%7
  • Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
  • Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder

Relapse

Clinical relapse requires one or more of:
Direct indicators of increasing disease and/or end organ dysfunction (CRAB features).6 It is not used in calculation of time to progression or progression-free survival but is listed here as something that can be reported optionally or for use in clinical practice

  • Development of new soft tissue plasmacytomas or bone lesions
  • Definite increase in the size of existing plasmacytomas or bone lesions. A definite increase is defined as a 50% (and at least 1 cm) increase as measured serially by the sum of the products of the cross-diameters of the measurable lesion
  • Hypercalcemia (> 11.5 mg/dL) [2.65 mmol/L]
  • Decrease in haemoglobin of > 2 g/dL [1.25 mmol/L]
  • Rise in serum creatinine by 2 mg/dL or more [177 mmol/L or more]

Relapse from CR5 (To be used only if the end point studied is DFS)8

Any one or more of the following:

  • Reappearance of serum or urine M-protein by immunofixation or electrophoresis
  • Development of > 5% plasma cells in the bone marrow7
  • Appearance of any other sign of progression (i.e., new plasmacytoma, lytic bone lesion, or hypercalcaemia)


1 BGM Durie et al. International uniform response criteria for multiple myeloma. Leukemia (2006) 1-7.
Adapted from Durie BGM, et al. Leukemia 2006; 20: 1467-1473; and Kyle RA, Rajkumar SV. Leukemia 2008;23:3-9.
Note: A clarification to IMWG criteria for coding CR and VGPR in patients in whom the only measurable disease is by serum FLC levels: CR in such patients is defined as a normal FLC ratio of 0.26–1.65 in addition to CR criteria listed above. VGPR in such patients is defined as a >90% decrease in the difference between involved and uninvolved free light chain (FLC) levels.
3 Confirmation with repeat bone marrow biopsy not needed.
4 Presence/absence of clonal cells is based upon the kappa/lambda ratio. An abnormal kappa/lambda ratio by immunohistochemistry and/or immunofluorescence requires a minimum of 100 plasma cells for analysis. An abnormal ratio reflecting presence of an abnormal clone is kappa/lambda of > 4:1 or < 1:2.
5 All relapse categories require two consecutive assessments made at anytime before classification as relapse or disease progression and/or the institution of any new therapy. In the IMWG criteria, CR patients must also meet the criteria for progressive disease shown here to be classified as progressive disease for the purposes of calculating time to progression and progression-free survival. The definitions of relapse, clinical relapse and relapse from CR are not to be used in calculation of time to progression or progression-free survival.
6 For progressive disease, serum M-component increases of >1 gm/dL are sufficient to define relapse if starting M-component is >5 g/dL.
7 Relapse from CR has the 5% cut-off versus 10% for other categories of relapse.
8 For purposes of calculating time to progression and progression-free survival, CR patients should also be evaluated using criteria listed above for progressive disease.


 related videos
 related articles
IMWG consensus state...
IMWG Guidelines for ...
IMWG Guidelines for ...
IMWG Guidelines for ...
IMWG Guidelines for ...
International Myelom...
A Practical Guide to...
ASCO 2010: A phase I...
ASCO 2010: Bone mark...
ASCO 2010: Elotuzuma...
ASCO 2010: Lenalidom...
ASCO 2010: Mechanism...
ASCO 2010: Modified ...
ASCO 2010: Multiple ...
ASCO 2010: Neurotoxi...
ASCO 2010: Phase I s...
ASCO 2010: Phase Ib ...
ASCO 2010: Results o...
ASCO 2010: Stromal e...
ASCO 2010: Total the...
Clinically relevant ...
Confirmation of the ...
Developing a SNP Cla...
Eliminating the comp...
ESAs not the culprit...
Genetic association ...
Genetic Associations...
Genetic Associations...
Genetic polymorphism...
Genetic Variations A...
Genomic variation in...
IMWG Criteria for th...
Inaugural Summit of ...
International Myelom...
Long-Term Follow-Up ...
Long-Term Follow-Up ...
New Approaches to Tr...
Oncology Nurses Take...
Osteonecrosis of the...
RT-PCR Amplicons in ...
Survival and Years o...
Use of Bisphosphonat...

Common Symptoms Of M...
Statement on the pas...
Advocacy Update - Se...
Advocacy Update - Se...

ASCO 2010: A phase II study of a modified pegylated liposomal doxorubicin (PLD), bortezomib, and dexamethasone regimen for patients with previously untreated multiple myeloma (MM).
ASCO 2010: Bone marker assessment as a guide to chronic use of aminobisphosphonates in multiple myeloma.
ASCO 2010: Elotuzumab in combination with bortezomib in patients with relapsed/refractory multiple myeloma: A phase I study.
ASCO 2010: Lenalidomide maintenance after transplantation for myeloma.
ASCO 2010: Mechanism of the antimyeloma activity of PU-H71, a novel purine scaffold HSP90 inhibitor.
ASCO 2010: Modified high-dose melphalan and autologous stem cell transplantation (mHDM/SCT) in the treatment of AL amyloidosis (AL) and/or high-risk myeloma (hM): Analysis of a Southwest Oncology Group trial.
ASCO 2010: Multiple myeloma is characterized by widespread epigenomic alterations with prognostic implications.
ASCO 2010: Phase I study of combined vorinostat (V), lenalidomide (L), and dexamethasone (D) in patients (pts) with relapsed or refractory multiple myeloma (MM).
ASCO 2010: Phase Ib study of oral panobinostat (LBH589) plus lenalidomide (LEN) plus dexamethasone (DEX) in patients (Pts) with relapsed (Rel) or Rel and refractory (Ref) multiple myeloma (MM).
ASCO 2010: Results of an ongoing open-label, phase II study of carfilzomib in patients with relapsed and/or refractory multiple myeloma (R/R MM).
ASCO 2010: Stromal elements and engraftment (ENG) in autologous hematopoietic progenitor cell transplant (autoHCT) for myeloma.
ASCO 2010: Total therapy 3 (TT3) for multiple myeloma (MM): Contributions to survival outcomes of dosing of maintenance components dexamethasone (D), thalidomide (T) and bortezomib (V).
What is multiple myeloma?
Dr. Morie Gertz of the Mayo Clinic in Rochester, MN.
IMWG consensus statement on the role of vertebral augmentation in multiple myeloma
IMWG Guidelines for Facilities and Services for the Management of Myeloma Patients
IMWG Guidelines for the Management of Multiple Myeloma Patients Ineligible for Standard High-Dose Chemotherapy with Autologous Stem Cell Transplantation
IMWG Guidelines for the Prevention of Thalidomide- and Lenalidomide-Associated Thrombosis in Myeloma
IMWG Guidelines for the Use of Bisphosphonates in Myeloma
International Myeloma Working Group Guidelines on Imaging Techniques in the Diagnosis and Monitoring of Multiple Myeloma1
A Practical Guide to Achieving and Maintaining the Best Response to Lenalidomide in Multiple Myeloma: Roundtable Proceedings
ASCO 2010: A phase II study of a modified pegylated liposomal doxorubicin (PLD), bortezomib, and dexamethasone regimen for patients with previously untreated multiple myeloma (MM).
ASCO 2010: Bone marker assessment as a guide to chronic use of aminobisphosphonates in multiple myeloma.
ASCO 2010: Elotuzumab in combination with bortezomib in patients with relapsed/refractory multiple myeloma: A phase I study.
ASCO 2010: Lenalidomide maintenance after transplantation for myeloma.
ASCO 2010: Mechanism of the antimyeloma activity of PU-H71, a novel purine scaffold HSP90 inhibitor.
ASCO 2010: Modified high-dose melphalan and autologous stem cell transplantation (mHDM/SCT) in the treatment of AL amyloidosis (AL) and/or high-risk myeloma (hM): Analysis of a Southwest Oncology Group trial.
ASCO 2010: Multiple myeloma is characterized by widespread epigenomic alterations with prognostic implications.
ASCO 2010: Neurotoxic and peripheral neuropathic effects in preclinical and clinical studies of carfilzomib (CFZ), a novel proteasome inhibitor (PI).
ASCO 2010: Phase I study of combined vorinostat (V), lenalidomide (L), and dexamethasone (D) in patients (pts) with relapsed or refractory multiple myeloma (MM).
ASCO 2010: Phase Ib study of oral panobinostat (LBH589) plus lenalidomide (LEN) plus dexamethasone (DEX) in patients (Pts) with relapsed (Rel) or Rel and refractory (Ref) multiple myeloma (MM).
ASCO 2010: Results of an ongoing open-label, phase II study of carfilzomib in patients with relapsed and/or refractory multiple myeloma (R/R MM).
ASCO 2010: Stromal elements and engraftment (ENG) in autologous hematopoietic progenitor cell transplant (autoHCT) for myeloma.
ASCO 2010: Total therapy 3 (TT3) for multiple myeloma (MM): Contributions to survival outcomes of dosing of maintenance components dexamethasone (D), thalidomide (T) and bortezomib (V).
Clinically relevant end points and new drug approvals for myeloma
Confirmation of the utility of the International Staging System and identification of a unique pattern of disease in Brazilian patients with multiple myeloma
Developing a SNP Classifier for Predicting Peripheral Neuropathy by Bortezomib in Multiple Myeloma Patients
Eliminating the complete response penalty from myeloma response criteria
ESAs not the culprit: More studies required
Genetic association with thalidomide mediated venous thrombotic events in myeloma indentified using targeted genotyping
Genetic Associations with Bortezomib Mediated Neuropathy in Multiple Myeloma
Genetic Associations with Therapy Response in the HOVON-65/GMMG-HD4 Trial in Patients with Multiple Myeloma
Genetic polymorphisms of EPHX1, Gsk3 beta, TNFSF8 and myeloma cell DKK-1 expression linked to bone disease in myeloma
Genetic Variations Associated with Overall and Progression-Free Survival in Multiple Myeloma Patients Treated with Thalidomide Combinations
Genomic variation in myeloma: design, content, and initial application of the Bank On A Cure SNP Panel to detect associations with progression-free survival
IMWG Criteria for the Diagnosis of Myeloma and Guidelines for the Diagnostic Work-Up of Myeloma
Inaugural Summit of the International Myeloma Working Group Lays the Groundwork for a Course Toward a Cure.
International Myeloma Working Group at ASH 2009
Long-Term Follow-Up of Autotransplantation Trials for Multiple Myeloma: Update of Protocols Conducted by the Intergroupe Francophone du Myelome, Southwest Oncology Group, and University of Arkansas for Medical Sciences
Long-Term Follow-Up of Autotransplantation Trials for Multiple Myeloma: Update of Protocols Conducted by the Intergroupe Francophone du Myelome, Southwest Oncology Group, and University of Arkansas for Medical Sciences
New Approaches to Treatment for Multiple Myeloma: Durable Remission and Quality of Life as Primary Goals
Oncology Nurses Take the Lead in Providing Novel Therapy Guidelines for Multiple Myeloma
Osteonecrosis of the Jaw and Biphosphonates
RT-PCR Amplicons in the Plasma of Multiple Myeloma Patients
Survival and Years of Life Lost in Different Age Cohorts of Patients With Multiple Myeloma
Use of Bisphosphonates in Multiple Myeloma: IMGW Response to Mayo Clinic Consensus Statement
WHAT IS MULTIPLE MYELOMA
Common Symptoms Of Multiple Myeloma
Statement on the passing of Senator Kennedy
Advocacy Update - September 1, 2009
Advocacy Update - September 15, 2009