Derivation and Validation of a Risk Assessment Model for Immunomodulatory Drug–Associated Thrombosis Among Patients With Multiple Myeloma

• DOI: 10.6004/jnccn.2018.7273
• Publication Date: 2019-07-18T19:55:03Z
• Authors: Ang Li; Qian Wu; Suhong Luo; Greg S. Warnick; Neil A. Zakai; Edward N. Libby; Brian F. Gage; David A. Garcia; Gary H. Lyman; Kristen M. Sanfil...
• Keywords: Aged, 80 and over; Male; Venous Thrombosis; Databases, Factual; Anticoagulants; Venous Thromboembolism; Middle Aged; Medicare; Risk Assessment; United States; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Risk Factors; Humans; Immunologic Factors; Female; Multiple Myeloma; Aged; Proportional Hazards Models

Abstract Background: Although venous thromboembolism (VTE) is a significant complication for patients with multiple myeloma (MM) receiving immunomodulatory drugs (IMiDs), no validated clinical model predicts VTE in this population. This study aimed to derive and validate new risk assessment (RAM) IMiD-associated VTE. Methods: Patients newly diagnosed MM IMiDs were selected from the SEER-Medicare database (n=2,397) RAM then data Veterans Health Administration (n=1,251) used externally model. A multivariable cause-specific Cox regression was development. Results: The final RAM, named “SAVED” score, included 5 variables: prior surgery, Asian race, history, age ≥80 years, dexamethasone dose. stratified approximately 30% of both derivation validation cohorts as high-risk. Hazard ratios (HRs) 1.85 ( P <.01) 1.98 high- versus low-risk groups cohorts, respectively. In contrast, method stratification recommended current NCCN Guidelines Cancer-Associated Venous Thromboembolic Disease had HRs 1.21 =.17) 1.41 =.07) corresponding 2 datasets. Conclusions: SAVED score outperformed risk-stratification IMiD therapy. can help inform providers before initiation provides simplified backbone further prognostic biomarker development