UPDATED RISK STRATIFICATION MODEL FOR SMOLDERING MULTIPLE MYELOMA (SMM) INCORPORATING THE REVISED IMWG DIAGNOSTIC CRITERIA
Author(s): ,
Maria-Victoria Mateos
Affiliations:
Hematology,University Hospital of Salamanca, IBSAL,Salamanca,Spain
,
Shaji Kumar
Affiliations:
Hematology,Mayo Clinic,Rochester,United States
,
Veronica Gonzalez
Affiliations:
Hematology,University Hospital of Salamanca, IBSAL,Salamanca,Spain
,
Meletios Dimopoulos
Affiliations:
Clinical Therapeutics,Alexandra General Hospital, Medical School, National and Kapodistrian University of Athens,Athens,Greece
,
Efstathios Kastritis
Affiliations:
Clinical Therapeutics, Alexandra General Hospital, Medical School, National and Kapodistrian University of Athens,Athens,Greece
,
Roman Hajek
Affiliations:
Hematology-Oncology,University Hospital Ostrava,Ostrava,Czech Republic
,
Carlos Fernández de Larrea Rodríguez
Affiliations:
Hematology,Hospital Clínic de Barcelona, Universitat de Barcelona Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS),Barcelona,Spain
,
Gareth Morgan
Affiliations:
Myeloma Center,University of Arkansas for Medical Sciences,Little Rock,United States
,
Giampaolo Merlini
Affiliations:
Molecular Medicine, Foundation 'Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo', University of Pavia,Pavia,Italy
,
Silvia Mangiacavalli
Affiliations:
Molecular Medicine,Foundation 'Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo', University of Pavia,Pavia,Italy
,
Hartmut Goldschmidt
Affiliations:
Medical Clinic V, Section Multiple Myeloma and National Centrum for Tumor Diseases (NCT),University Hospital Heidelberg,Heidelberg,Germany
,
Michele Cavo
Affiliations:
“Seràgnoli” Institute of Hematology,Bologna University School of Medicine,Bologna,Italy
,
Elena Zamagni
Affiliations:
“Seràgnoli” Institute of Hematology,Bologna University School of Medicine,Bologna,Italy
,
Charalampia Kyriakou
Affiliations:
Haematology,University College London & London North West Healthcare NHS Trust,London,United Kingdom
,
Kristopher Standish
Affiliations:
Janssen Research and Development, LLC,La Jolla,United States
,
Ming Qi
Affiliations:
Janssen Research and Development, LLC,Spring House,United States
,
Jon Ukropec
Affiliations:
Janssen Global Medical Affairs,Raritan,United States
,
Brendan Weiss
Affiliations:
Janssen Research and Development, LLC,Spring House,United States
,
Chris Cameron
Affiliations:
Cornerstone Research Group Inc.,Burlington,Canada
,
Steve Doucette
Affiliations:
Cornerstone Research Group, Inc.,Burlington,Canada
,
S. Vincent Rajkumar
Affiliations:
Hematology,Mayo Clinic,Rochester,United States
,
Brian Durie
Affiliations:
Hematology/Oncology,Cedars-Sinai Outpatient Cancer Center,Los Angeles,United States
Jesus San Miguel
Affiliations:
Clinical & Translational Medicine,Clínica Universidad de Navarra,Pamplona,Spain
EHA Library. Mateos M. Jun 15, 2019; 266966; PS1349
Dr. María-Victoria Mateos
Dr. María-Victoria Mateos
Contributions
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Abstract

Abstract: PS1349

Type: Poster Presentation

Presentation during EHA24: On Saturday, June 15, 2019 from 17:30 - 19:00

Location: Poster area

Background
The diagnostic criteria for MM were revised in 2014, recategorizing ultra-high risk (i.e., 80% at two years) as active myeloma requiring therapy. The removal of patients at the highest risk of progression from the smoldering group requires reassessment of current risk stratification models.

Aims
Primary Objective: Develop a risk stratification system that will identify patients at high risk of progression to MM or related disorders (50% at 2 years)

Secondary objectives:

1. Identify patients at >80% risk of developing myeloma in 2 years

2. Describe the natural history of smoldering myeloma

3. Describe survival outcomes of patients with SMM who have progressed to symptomatic MM

Methods
We designed a multicenter, retrospective study of SMM patients to develop a risk stratification model. Patients diagnosed with SMM on/after January 1, 2004 were included if they had no disease progression within 6 months, had baseline data from diagnosis (+/- 3 months), had a follow up of ≥1 year, and did not participate in a therapeutic trial of SMM. Various clinical and laboratory factors were explored to identify factors that predicted progression at 2 years. Univariate Cox regressions were run for each factor. For factors with p-values ≤ 0.25, optimal cut points were identified using Youden’s index. Binary factors were used in stepwise regression to fit multivariable Cox model and significant risk factors were determined (F-test).

Results
Overall, 2004 patients were included (ages 26-93, 51% female). Factors independently associated with progression (optimal cutoffs) included: Serum M protein (2 g/dL), involved to uninvolved serum-free light chain ratio (20), and marrow plasma cell % (20%). Patients were stratified using the risk factors: Low- (0 factors), Intermediate- (1), and High-Risk (≥2). Previously used high risk markers such as Bence Jones proteinuria (>=500 mg/24 hours) and severe immunoparesis (50% decrease in uninvolved immunoglobulin levels) were both significant in univariate analysis, but were eliminated on step wise selection. Compared to the low risk group, intermediate- and high-risk groups had significantly higher rate of progression (Table). Within the high-risk group, having all 3 risk factors (n=61) versus 2 did not add to the model, with insufficient separation between 2 and 3 factors. 

Conclusion
We have developed a risk stratification model for SMM that incorporates revised cutoffs for previously used parameters (20/2/20) that can be universally applied. Additonal analysis are being conducted to develop models that utilize common cytogenetic abnormalities, as well as those without FLC given lack of availability of all tests across the world. 

Session topic: 13. Myeloma and other monoclonal gammopathies - Biology & Translational Research

Keyword(s): High risk, Multiple myeloma, Prognosis, Smoldering

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