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  ["project_title"]=>
  string(151) "Thrombotic events in patients with relapsed and refractory multiple myeloma treated with single agent daratumumab or daratumumab-based triplet regimens"
  ["project_narrative_summary"]=>
  string(770) "The treatment and outcomes of MM are evolving rapidly. Thromboembolic complications continue to be frequently seen in this population and are an important source of morbidity and mortality.  An analysis of the GRIFFIN study showed a 10-15.7% incidence of venous thromboembolism (VTE) in NDMM patients treated with lenalidomide, bortezomib, and dexamethasone with or without daratumumab. Approximately 65% of these patients were on prophylactic anticoagulation. However, the rate of VTE in RRMM patients has yet to be characterized. This study aims to assess the rate of thromboembolic events in RRMM patients. These results will help clinicians understand the risk of thromboembolism in RRMM patients and the effectiveness of the different thromboprophylaxis strategies."
  ["project_learn_source"]=>
  string(5) "other"
  ["project_learn_source_exp"]=>
  string(27) "I have used YODA previously"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(7) "Douglas"
    ["last_name"]=>
    string(6) "Sborov"
    ["degree"]=>
    string(5) "MD MS"
    ["primary_affiliation"]=>
    string(51) "Huntsman Cancer Institute at the University of Utah"
    ["email"]=>
    string(27) "douglas.sborov@hci.utah.edu"
    ["state_or_province"]=>
    string(2) "UT"
    ["country"]=>
    string(13) "United States"
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  ["project_key_personnel"]=>
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    ["value"]=>
    string(2) "no"
    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
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  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(4396) "Background: Multiple myeloma (MM) is an incurable malignancy associated with an estimated 5-year survival of 54% and approximately 13,000 deaths in the US annually. Advances in treatment options have significantly improved survival, and while novel combination regimens lead to objective responses in most patients, disease and treatment-related morbidity persist. Patients with relapsed/refractory multiple myeloma (RRMM) have a similar risk of developing a venous thromboembolism compared to newly diagnosed patients, which has been estimated to be a nine-fold increase. Despite the availability of the IMWG and NCCN VTE prophylaxis guidelines and updated risk stratification models such as SAVED and IMPEDE, the optimal thromboprophylaxis strategy remains unknown, especially in the age of modern daratumumab-containing regimens. 



Objective: The overall aim of this project is to assess the incidence of thromboembolic events in RRMM patients and investigate the impact of various VTE prophylactic strategies on the rate of VTE based on SAVED/IMPEDE risk stratification for patients with RRMM enrolled in clinical trials evaluating the use of Daratumumab. 



Study Design: This retrospective study will include individual participant data (IPD) obtained from YODA; patients with RRMM will be divided into those with and without thromboembolic complications, calculated and graded using the CTCAv4. Both venous (deep venous thrombosis, pulmonary embolism, and superficial thrombosis) and arterial events (cerebrovascular accidents) will be examined. The relationship between VTE and progression-free survival (PFS), overall survival (OS), duration of response (DOR), SAVED/IMPEDE scores, lines of treatment, use of prophylactic anticoagulation, and time to event in the thromboembolism arm will be explored.

Participants: Patients with relapsed/refractory multiple myeloma (RRMM) patients enrolled in trials including treatment with single agent daratumumab (NCT00574288, NCT03277105) and daratumumab-based combination regimens (NCT01615029, NCT03277105, NCT03412565, NCT03180736, NCT01998971, and NCT01985126).



Primary Outcomes: The rate of thromboembolic events in patients treated with 1) daratumumab single agent, 2) daratumumab, bortezomib, and dexamethasone, 3) daratumumab, lenalidomide, and dexamethasone, and 5) daratumumab, pomalidomide, and dexamethasone.



Secondary outcomes: Rates of VTE stratified by SAVED and IMPEDE risk stratification models in patients treated with 1) daratumumab single agent, 2) daratumumab, bortezomib, and dexamethasone, 3) daratumumab, lenalidomide, and dexamethasone, and 5) daratumumab, pomalidomide, and dexamethasone. Additional secondary outcomes to be measured include prior lines of therapy, time from diagnosis to VTE onset, time from treatment initiation to VTE onset, CTCAE grade of VTE events, type of thromboprophylaxis treatment, duration of thromboprophylaxis treatment, rate and quality of bleeding events, overall drug exposure, and rates of grade 3 or higher thrombocytopenia per treatment regimen.



Statistical Analysis: A descriptive analysis describing the patient’s disease clinical and biological features, treatments, and outcomes is planned. Continuous variables will be summarized as means or medians, including standard deviations and ranges. Differences between continuous variables will be examined using the t-test, and the Mann-Whitney test will be used to examine non-normally distributed measurements. Categorical variables will be summarized as frequencies, and associations between these variables will be tested via the chi-squared test. Incidence of VTE rates will be estimated overall and stratified by IMPEDE and SAVED risk scores, along with exact 95% confidence intervals. Comparisons of VTE rates across IMPEDE and SAVED risk strata will be conducted in the context of logistic regression models in univariate and multivariable analyses adjusted for patient characteristics. VTE rates will be estimated and compared across VTE prophylactic strategies, based on logistic regression models, in univariate analyses separately within IMPEDE and SAVED risk strata and multivariable analyses adjusted for potential confounders. Patient characteristics will also be considered as moderators of VTE prophylactic strategy comparisons.

"
  ["project_brief_bg"]=>
  string(2570) "Compared to the general population, patients with multiple myeloma (MM) have an approximate seven to nine-fold increased risk of developing a venous thromboembolism (VTE) (1). Similarly, the cumulative incidence of arterial thromboembolisms (ATE) in the first year following the diagnosis of MM is approximately 2%(2). The underlying pathogenesis of thromboembolic events in MM patients remains poorly understood; however, possible risk factors include older age, previous VTE, surgery, central venous catheters, infections, immobilization, acquired and inherited hypercoagulable conditions, and therapeutic agents such as immunomodulatory (IMiDs), steroids and erythropoietin stimulating agents (ESA) use(3). This observed increased incidence of thromboembolic events in MM patients has led to the development and validation of two main risk stratification models to assess the risk of VTE in patients with NDMM: the SAVED and IMPEDE scores, which have been incorporated into the National Comprehensive Cancer Network (NCCN) guidelines and the International Myeloma Working Group (IMWG) to guide thromboprophylaxis efforts in patients with newly diagnosed MM. Although most of the attention has been focused on the VTE risk in patients with NDMM, patients with RRMM have a similar rate of VTE compared to NDMM patients(4). Despite the development of these risk scores and the increasing interest in understanding the underlying factors associated with MM and VTE, the rate of VTE in MM and its associated morbidity remains high, suggesting that the optimal thromboprophylaxis strategy is still unknown. Recently, three landmark clinical trials have assessed the role of daratumumab-based regimens for the treatment of patients with RRMM have been published, including POLLUX, APOLLO, and CASTOR(5–7). Thromboprophylaxis was recommended in each of these trials, per IMWG guidelines. Still, the rates of VTE and bleeding based on the type of anticoagulation were not reported as part of the original publication. Recently, two post-hoc analyses of GRIFFIN and MAIA showed that in the modern era, patients with NDMM continue to have a high incidence of VTE despite thromboprophylaxis recommendations (8,9). Therefore, understanding current practice patterns in patients with RRMM via retrospective analysis of these trials will determine the impact of various thromboprophylaxis strategies on the incidence of VTE and, ultimately, guide the design of prospective clinical trials aimed at minimizing VTE and optimizing patient safety continues to be of utmost importance."
  ["project_specific_aims"]=>
  string(1159) "Aim 1: Calculate the baseline SAVED risk scoring and stratification of patients with relapsed/refractory multiple myeloma (RRMM) patients enrolled in trials including treatment with single agent daratumumab (NCT00574288, NCT03277105) and daratumumab-based combination regimens (NCT01615029, NCT03277105, NCT03412565, NCT03180736, NCT01998971, and NCT01985126).



Aim 2: Calculate the baseline IMPEDE risk scoring and stratification of RRMM patients enrolled in trials including treatment with single agent daratumumab (NCT00574288, NCT03277105) and daratumumab-based combination regimens (NCT01615029, NCT03277105, NCT03412565, NCT03180736, NCT01998971, and NCT01985126).



Aim 3: Determine the incidence of venous and arterial thromboembolism and investigate the impact of various thromboembolism prophylaxis strategies [low vs. high dose aspirin, prophylactic vs. therapeutic dose anticoagulants [e.g. low molecular weight heparin, direct oral anticoagulants (DOACs), warfarin etc.] on the rate of thromboembolism based on SAVED risk stratification (low, intermediate or high risk) and IMPEDE if adequate data is available.

"
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(14) "indiv_trial_an"
    ["label"]=>
    string(25) "Individual trial analysis"
  }
  ["project_purposes"]=>
  array(2) {
    [0]=>
    array(2) {
      ["value"]=>
      string(69) "confirm_or_validate previously_conducted_research_on_treatment_safety"
      ["label"]=>
      string(69) "Confirm or validate previously conducted research on treatment safety"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(50) "research_on_clinical_prediction_or_risk_prediction"
      ["label"]=>
      string(50) "Research on clinical prediction or risk prediction"
    }
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      ["label"]=>
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  ["project_research_methods"]=>
  string(269) "All patients enrolled in trials including treatment with single agent daratumumab (NCT00574288, NCT03277105) and daratumumab-based combination regimens (NCT01615029, NCT03277105, NCT03412565, NCT03180736, NCT01998971, and NCT01985126) will be included in this analysis."
  ["project_main_outcome_measure"]=>
  string(1129) "Primary: Rate of VTE for patients treated with 1) daratumumab single agent, 2) daratumumab, bortezomib, and dexamethasone, 3) daratumumab, lenalidomide, and dexamethasone, and 5) daratumumab, pomalidomide, and dexamethasone. Rates of VTE will be defined as any grade 1 - 5 arterial or venous thromboembolic event as defined by CTCAE v4 grading criteria.



Secondary: Rates of VTE within SAVED and IMPEDE risk stratification models for patients treated with 1) daratumumab single agent, 2) daratumumab, bortezomib, and dexamethasone, 3) daratumumab, lenalidomide, and dexamethasone, and 5) daratumumab, pomalidomide, and dexamethasone. Addition secondary outcomes include time from diagnosis to VTE onset,  time from treatment initiation to VTE onset, CTCAE grade of VTE events, type of thromboprophylaxis treatment, duration of thromboprophylaxis treatment, rate and grade of bleeding events per CTCAE v4, overall drug exposure as defined as time of treatment initiation to end of study drug including dose holds and dose modifications, prior lines of therapy and rates of grade 3 or higher thrombocytopenia.

"
  ["project_main_predictor_indep"]=>
  string(14) "Not applicable"
  ["project_other_variables_interest"]=>
  string(829) "Other variables of interest will include the following:

1) Demographics including age, race, myeloma subtype, R-ISS/ISS/R2-ISS risk at diagnosis, tumor burden as measured by serum/urine biomarkers, bone marrow aspirate/biopsy, cytogenetics at diagnosis and diagnostic imaging

2) IMPEDE risk score calculation includes Patient BMI at screening, presence or absence of fracture (pelvis, hip, or femur), use of erythropoietin stimulating agents (ESA), race (Asian/Pacific Islander vs other), history of prior VTE, presence or absence of central venous catheter, pretreatment use of prophylactic or therapeutic anticoagulation

3) SAVED risk score calculation includes Surgery within 90 days, Asian race, VTE history, age > 80, treatment with dexamethasone (low (120-160 mg) vs high (> 160 mg) dose)

"
  ["project_stat_analysis_plan"]=>
  string(1369) "A descriptive analysis of describing disease clinical and biologic features, treatments, and outcomes is planned. Continuous variables will be summarized as means or medians including standard deviations and range, respectively. Differences between continuous variables will be examined using the t-test, and the Mann-Whitney test will be used to examine non-normally distributed measurements. Categorical variables will be summarized as frequencies and associations between these variables will be tested via the chi-squared test.



Incident VTE rates will be estimated overall, and separately within IMPEDE risk strata, along with exact 95% confidence intervals3. Comparisons of VTE rates across IMPEDE risk strata will be conducted in the context of logistic regression models, in univariate analyses as well as multivariable analyses adjusted for patient characteristics. VTE rates will be estimated and compared across VTE prophylactic strategies, again based on logistic regression models, in univariate analyses separately within IMPEDE risk strata as well as multivariable analyses adjusted for potential confounders. Patient characteristics will be also be considered as moderators of VTE prophylactic strategy comparisons, to assess evidence that particular VTE prophylactic strategies need to be tailored to particular types of patients.

"
  ["project_timeline"]=>
  string(329) "The proposed timeline for completion of this project, including data retrieval, review, and analysis, is 6 months. It is planned that this data will be submitted for presentation at the 2024 American Society of Hematology Annual Meeting (submission approximately 1-Aug-2024) and initial submission for publication by 1-Nov-2024. "
  ["project_dissemination_plan"]=>
  string(345) "The proposed plan for data dissemination is for submission to the 2024 American Society of Hematology (ASH) Annual Meeting in December 2024. In conjunction with the presentation of this data at ASH, our group plans to submit it for publication to Blood Advances, American Journal of Hematology, or British Journal of Hematology in November 2024."
  ["project_bibliography"]=>
  string(3209) "

Kristinsson SY. Thrombosis in Multiple Myeloma. Hematology [Internet]. 2010 Dec 4;2010(1):437–44. Available from: https://ashpublications.org/hematology/article/2010/1/437/96384/Thrombosis-in-Multiple-Myeloma
Chakraborty R, Rybicki L, Valent J, Garcia AVM, Faiman BM, Khouri J, et al. Arterial thromboembolism in multiple myeloma in the context of modern anti-myeloma therapy. Blood Cancer J [Internet]. 2021 Jun 25;11(6):121. Available from: https://www.nature.com/articles/s41408-021-00513-4
Landgren O, Kyle RA, Pfeiffer RM, Katzmann JA, Caporaso NE, Hayes RB, et al. Monoclonal gammopathy of undetermined significance (MGUS) consistently precedes multiple myeloma: a prospective study. Blood [Internet]. 2009 May 28;113(22):5412–7. Available from: https://ashpublications.org/blood/article/113/22/5412/107762/Monoclonal-gammopathy-of-undetermined-significance
Chakraborty R, Bin Riaz I, Malik SU, Marneni N, Mejia Garcia A, Anwer F, et al. Venous thromboembolism risk with contemporary lenalidomide-based regimens despite thromboprophylaxis in multiple myeloma: A systematic review and meta-analysis. Cancer [Internet]. 2020 Apr 15;126(8):1640–50. Available from: http://www.ncbi.nlm.nih.gov/pubmed/31913498
Dimopoulos MA, Terpos E, Boccadoro M, Delimpasi S, Beksac M, Katodritou E, et al. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol [Internet]. 2021 Jun;22(6):801–12. Available from: https://linkinghub.elsevier.com/retrieve/pii/S1470204521001285
Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, et al. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med [Internet]. 2016 Oct 6;375(14):1319–31. Available from: http://www.nejm.org/doi/10.1056/NEJMoa1607751
Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, et al. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med [Internet]. 2016 Aug 25;375(8):754–66. Available from: http://www.nejm.org/doi/10.1056/NEJMoa1606038
Sborov DW, Baljevic M, Reeves B, Laubach J, Efebera YA, Rodriguez C, et al. Daratumumab plus lenalidomide, bortezomib and dexamethasone in newly diagnosed multiple myeloma: Analysis of vascular thrombotic events in the <scp>GRIFFIN</scp> study. Br J Haematol [Internet]. 2022 Nov 16;199(3):355–65. Available from: https://onlinelibrary.wiley.com/doi/10.1111/bjh.18432
Rosqvist S, Vardell VA, Anto E, Fortuna GG, Peters D, Wagner CB, et al. High Rates of Thrombotic Events in Newly Diagnosed Multiple Myeloma Patients Enrolled on the Maia Trial. Blood [Internet]. 2023 Nov 28;142(Supplement 1):4718–4718. Available from: https://ashpublications.org/blood/article/142/Supplement 1/4718/503720/High-Rates-of-Thrombotic-Events-in-Newly-Diagnosed

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