PROMISE Study Provides ‘Most Precise’ Estimates of MGUS in High-Risk Patients

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The PROMISE study revealed a 10% incidence of monoclonal gammopathy of undetermined significance (MGUS) among patients at high risk of multiple myeloma (MM).

These results were presented at the 2021 American Society of Hematology (ASH) Annual Meeting by Habib El-Khoury, MD, of the Dana-Farber Cancer Institute in Boston.

The aims of the PROMISE study (ClinicalTrials.gov Identifier: NCT03689595) were to determine the prevalence of MGUS in a population of patients at high risk of MM and characterize clinical variables in patients who were found to have MGUS.


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Patient Details

The study enrolled patients age 40 or older who self-identified as Black or African American and patients age 40 or older of any race who had a family history of hematologic malignancy or MM precursor condition.

Patients age 18 or older could be enrolled as well, but only if they had a strong family history, defined as 2 or more first- and second-degree relatives with a hematologic malignancy or MM precursor condition. The study also included a control group derived from individuals in the Mass General Brigham Biobank.

The researchers screened patients using matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) as well as serum protein electrophoresis (SPEP) and immunofixation (IFX).  

The researchers screened 7622 patients in all — 2211 from the PROMISE study and 5411 from the biobank. The final cohort included 2439 Black individuals, 3866 non-Black individuals with a family history, and 631 control individuals who were not Black and had a negative family history.

Patients were classified as having MGUS if they had monoclonal protein concentrations at or above 0.2 g/L.

Results

The overall prevalence of MGUS, as detected by MALDI-TOF MS, was 10%. Among patients age 50 or older, the prevalence of MGUS was 13% by MALDI-TOF MS and 6% by SPEP/IFX.

When comparing high-risk groups and control individuals older than 50 years, the rates of MGUS by MALDI-TOF MS were higher among the high-risk patients. The MGUS incidence was 10% among control individuals, 17% among Black patients (P =.001), and 13% among non-Black patients with a family history (P <.001).

A multivariate analysis suggested the following factors were predictors of MGUS — age (15-year increase; odds ratio [OR], 1.93; 95% CI, 1.76-2.12; P <.001), male sex (OR, 1.18; 95% CI, 1.01-1.38; P =.034), and Black race (OR, 1.64; 95% CI, 1.20-2.30; P =.003).

The researchers also found that MGUS was significantly associated with worse all-cause mortality (hazard ratio, 2.34; 95% CI, 1.59-3.46; P <.001).

Dr El-Khoury concluded that these data demonstrate “the most precise estimates of MGUS in a high-risk screened population, reaching 13% to 17% in high-risk individuals above the age of 50.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

El-Khoury H, Alberge JB, Barr H, et al. High prevalence of monoclonal gammopathy in a population at risk: The first results of the PROMISE study. Presented at ASH 2021; December 11-14, 2021. Abstract 152.



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