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Session: Hematologic Malignancies—Plasma Cell Dyscrasia

Type: Oral Abstract Session

Time: Sunday June 2, 9:45 AM to 12:45 PM

Location: E451

Updated risk stratification model for smoldering multiple myeloma (SMM) incorporating the revised IMWG diagnostic criteria.

Multiple Myeloma

Hematologic Malignancies—Plasma Cell Dyscrasia

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr 8000)

Author(s): Jesus San Miguel, Maria-Victoria Mateos, Veronica Gonzalez, Meletios A. Dimopoulos, Efstathios Kastritis, Roman Hajek, Carlos Fernández de Larrea Rodríguez, Gareth John Morgan, Giampaolo Merlini, Silvia Mangiacavalli, Hartmut Goldschmidt, Michele Cavo, Charalampia Kyriakou, Ming Qi, Jon Ukropec, Brendan M. Weiss, Chris Cameron, S. Vincent Rajkumar, Brian G. Durie, Shaji Kumar; Clínica Universidad de Navarra-CIMA, IDISNA, CIBERONC, Pamplona, Spain; University of Salamanca Hospital/IBSAL, Salamanca, Spain; University Hospital of Salamanca, Salamanca, Spain; National and Kapodistrian University of Athens, Athens, Greece; National and Kapodistrian University of Athens School of Medicine, Athens, Greece; Masaryk University Hospital, Brno, Czech Republic; Hospital Clínic de Barcelona., Barcelona, Spain; University of Arkansas for Medical Science, London, AR; Scientific Institute Policlinico San Matteo, University of Pavia, Pavia, Italy; Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; University of Heidelberg, Heidelberg, Germany; S. Orsola University Hospital, Bologna, Italy; Royal Free Hospital, Northwood, United Kingdom; Janssen Research & Development, LLC, Raritan, NJ; Janssen Research & Development, LLC, Spring House, PA; Cornerstone Research Group, Inc., Burlington, ON, Canada; Mayo Clinic, Rochester, MN; Cedars-Sinai Comprehensive Cancer Center, Los Angeles, CA

Abstract Disclosures


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. 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. Conclusions: 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.

Risk FactorsNHRP2yr Prog (%)
13122.25 (1.68 to 3.01)<.00117
≥24155.63 (4.34 to 7.29)<.00146

Other Abstracts in this Sub-Category:


1. E3A06: Randomized phase III trial of lenalidomide versus observation alone in patients with asymptomatic high-risk smoldering multiple myeloma.

Meeting: 2019 ASCO Annual Meeting Abstract No: 8001 First Author: Sagar Lonial
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma


2. Efficacy of carfilzomib lenalidomide dexamethasone (KRd) with or without transplantation in newly diagnosed myeloma according to risk status: Results from the FORTE trial.

Meeting: 2019 ASCO Annual Meeting Abstract No: 8002 First Author: Francesca Gay
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma


3. Phase 3 randomized study of daratumumab (DARA) + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 1 results.

Meeting: 2019 ASCO Annual Meeting Abstract No: 8003 First Author: Philippe Moreau
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma