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  string(143) "Thromboembolism Prophylaxis and the Incidence of Venous Thromboembolism in Newly Diagnosed Multiple Myeloma Patients Enrolled on the MAIA trial"
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  string(677) "Multiple myeloma (MM) patients have a nine-fold increased risk of venous thromboembolism (VTE). VTE incidence is highest during the first 6 months following diagnosis and the optimal prophylaxis strategy is unknown, especially in patients treated with newer drugs like daratumumab. This retrospective study aims to investigate VTE risk and incidence for patients enrolled on the randomized phase 3 MAIA trial, correlate the baseline risk of VTE per SAVED score with overall VTE incidence, and examine the degree to which anti-thrombosis prophylaxis was administered. Ultimately, this data will provide key insights to inform the appropriate design of future prospective trials."
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      string(8) "Baljevic"
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      string(36) "Vanderbilt University Medical Center"
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      string(8) "Victoria"
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      string(7) "Vardell"
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      string(2) "MD"
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      string(18) "University of Utah"
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      string(3) "Ben"
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      string(7) "Haaland"
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      string(3) "PhD"
      ["p_pers_pr_affil"]=>
      string(25) "Huntsman Cancer Institute"
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      string(4) "Anto"
      ["p_pers_degree"]=>
      string(2) "MS"
      ["p_pers_pr_affil"]=>
      string(18) "University of Utah"
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    string(68) "No external grants or funds are being used to support this research."
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      string(225) "NCT02252172 - A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy"
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      string(269) "NCT02195479 - A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy"
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  ["project_date_type"]=>
  string(91) "Individual Participant-Level Data, which includes Full CSR and all supporting documentation"
  ["property_scientific_abstract"]=>
  string(3486) "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. Significant improvements in treatment options have significantly improved survival and while novel combination regimens lead to objective responses in > 90% of patients, disease and treatment-related morbidity persist. Venous thromboembolism (VTE) continues to be a significant issue for all patients with MM and VTE prophylaxis guidelines are outdated and not routinely utilized. 

Objective: Ultimately, the optimal VTE prophylactic strategy is unknown and the overall objective of the present project is to determine the incidence of VTE and investigate the impact of various VTE prophylactic strategies on the rate of VTE based on SAVED risk stratification for patients with newly diagnosed transplant ineligible MM enrolled on clinical trials including treatment with daratumumab. 

Study design: The present study will retrospectively investigate the incidence of VTE and investigate the impact of various VTE prophylactic strategies on the rate of VTE based on SAVED risk stratification for patients with transplant ineligible newly diagnosed multiple myeloma.

Participants: All patients randomized on the phase 3 MAIA and ALCYONE trials.

Primary outcome: Rate of VTE for patients treated with 1) daratumumab, lenalidomide, and dexamethasone, 2) lenalidomide and dexamethasone, 3) velcade, melphalan, and prednisone, and 4) daratumumab, velcade, melphalan, and prednisone.

Secondary outcomes: Rates of VTE within SAVED and IMPEDE risk stratification models for patients treated with 1) daratumumab, lenalidomide, and dexamethasone, 2) lenalidomide and dexamethasone, 3) velcade, melphalan, and prednisone, and 4) daratumumab, velcade, melphalan, and prednisone. Additional secondary outcomes to be measured include 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, overall drug exposure, and rates of grade 3 or higher thrombocytopenia per treatment regimen.

Statistical analysis: A descriptive analysis 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 and SAVED risk strata, 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 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 and SAVED 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."
  ["project_brief_bg"]=>
  string(3056) "Patients with multiple myeloma (MM) have a nine-fold increased risk of developing venous thromboembolism (VTE) compared to the general population and have increased risk of mortality associated with these events. The incidence of VTE in MM is considered to be highest during the first 6 months after diagnosis. Given the progression to ?triplet? and ?quad? induction therapies, the incidence as well as the prevalence, of venous thromboembolism complications in MM are expected to rise.

Routine administration of VTE prophylaxis with anticoagulation is an effective way to decrease the burden of VTE in cancer patients and multiple trials have shown that low molecular weight heparin (LMWH) and various direct oral anticoagulants (DOAC) reduce VTE risk without increased risk of major bleeding. Despite the significant amount of data available for cancer patients, the applicability of these findings for patients with MM is limited due to the fact that very few MM patients were included in these trials (some < 2%). 

The National Comprehensive Cancer Network (NCCN) guidelines recommend that decisions regarding thromboprophylaxis in MM patients be based on VTE risk assessment. Several risk stratification systems such as the International Myeloma Working Group (IMWG) VTE guidelines exist, but even with these guidelines available, only ~20% of patients receive the appropriate prophylaxis11. Additionally, the accuracy of these assessment tools has been shown to poorly correlate with the development of VTE. In fact, despite a protocol-stipulated thrombosis risk assessment using the IMWG guidelines coupled with a minimum recommended 3 months of thromboprophylaxis, rates of VTE remained greater than 10% on the Myeloma XI trial. To improve upon the prediction of VTE in patients with NDMM starting chemotherapy, the SAVED VTE model was developed. This scoring system allows adjustment for baseline use of dexamethasone, surgery within 90 days of starting treatment, history of VTE, age > 80, and Asian race. 

There are a number of significant questions that exist in respect to VTE prophylaxis in patients with MM including the effect of modern multi-drug induction regimens on the incidence of VTE and optimal choice of VTE thromboprophylaxis regimen based on SAVED and other risk stratification models. In the past 5 years, a number of landmark trials investigating novel multi-drug combinations for the treatment of patients with MM have been published, including ENDURANCE, GRIFFIN, CASSIOPEIA, MAIA, SWOG S0777, POLLUX, and CASTOR amongst other. In each of these trials, thromboprophylaxis per IMWG guidelines was recommended but the rates of VTE and bleeding based on type of anticoagulation has not been reported. Understanding modern practice patterns in patients with MM via retrospective analysis of these trials will determine the impact of various thromboprophylactic strategies on incidence of VTE, and ultimately, guide the design of prospective clinical trials aimed at minimizing VTE and optimizing patient safety."
  ["project_specific_aims"]=>
  string(866) "Aim 1: Calculate the baseline SAVED risk scoring and stratification of newly diagnosed transplant ineligible multiple myeloma (NDMM) patients enrolled on the randomized phase 3 MAIA and ALCYONE trials.

Aim 2: Calculate the baseline IMPEDE risk scoring and stratification of newly diagnosed transplant ineligible multiple myeloma (NDMM) patients enrolled on the randomized phase 3 MAIA and ALCYONE trials.

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"]=>
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    ["label"]=>
    string(25) "Individual trial analysis"
  }
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  ["project_purposes"]=>
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    [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]=>
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      ["value"]=>
      string(50) "Research on clinical prediction or risk prediction"
      ["label"]=>
      string(50) "Research on clinical prediction or risk prediction"
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  ["project_purposes_exp"]=>
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  ["project_software_used"]=>
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    ["value"]=>
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    ["label"]=>
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  ["project_software_used_exp"]=>
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  ["project_research_methods"]=>
  string(106) "All patients enrolled on the randomized phase 3 MAIA and ALCYONE trials will be included in this analysis."
  ["project_main_outcome_measure"]=>
  string(1055) "Primary: Rate of VTE for patients treated with 1) daratumumab, lenalidomide, and dexamethasone, 2) lenalidomide and dexamethasone, 3) velcade, melphalan, and prednisone, and 4) daratumumab, velcade, melphalan, and prednisone. 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, lenalidomide, and dexamethasone, 2) lenalidomide and dexamethasone, 3) velcade, melphalan, and prednisone, and 4) daratumumab, velcade, melphalan, and prednisone. Addition secondary outcomes include 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, and rates of grade 3 or higher thrombocytopenia"
  ["project_main_predictor_indep"]=>
  string(2) "NA"
  ["project_other_variables_interest"]=>
  string(780) "Others variables of interest will include the following:

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

2) IMPEDE risk score calculation includes Patient BMI at screening, presence of absence of fracture (pelvis, hip, or femur), use of erythropoietin stimulating agents (ESA), race (Asian/Pacific Islander vs other), history of prior VTE, presence of 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(1864) "A descriptive analysis 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 and SAVED risk strata, 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 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 and SAVED 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.

In secondary analyses, VTE prophylactic strategies will be compared via matching weighted logistic regressions. Multinomial propensity models will be constructed based on potential confounders via random forest. Balancing of potential confounders across strategy comparison groups will be assessed in terms of standardized mean differences. Effect moderation and patient tailoring will be assessed in subgroup analyses, accompanied by tests of moderator by treatment interaction."
  ["project_timeline"]=>
  string(326) "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 2023 American Society of Hematology Annual Meeting (submission approximately 1-Aug-2023) and initial submission for publication by 1-Nov-2023."
  ["project_dissemination_plan"]=>
  string(338) "The proposed plan for data dissemination is for submission to the 2023 American Society of Hematology (ASH) Annual Meeting in December 2023. In conjunction with presentation of this data at ASH, our group plans to submit for publication to Blood Advances, American Journal of Hematology, or British Journal of Hematology in November 2023."
  ["project_bibliography"]=>
  string(5062) "
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA: a cancer journal for clinicians 2020;70(1):7-30. DOI: https://doi.org/10.3322/caac.21590.

Voorhees PM, Kaufman JL, Laubach J, et al. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood 2020;136(8):936-945. (In eng). DOI: 10.1182/blood.2020005288.

Facon T, Kumar S, Plesner T, et al. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. The New England journal of medicine 2019;380(22):2104-2115. (In eng). DOI: 10.1056/NEJMoa1817249.

Sanfilippo KM, Luo S, Wang TF, et al. Predicting venous thromboembolism in multiple myeloma: development and validation of the IMPEDE VTE score. American journal of hematology 2019;94(11):1176-1184. (In eng). DOI: 10.1002/ajh.25603.

Agresti A, Coull BA. Approximate is Better than ?Exact? for Interval Estimation of Binomial Proportions. The American Statistician 1998;52(2):119-126. DOI: 10.1080/00031305.1998.10480550.

Kristinsson SY, Pfeiffer RM, Bjrkholm M, Schulman S, Landgren O. Thrombosis is associated with inferior survival in multiple myeloma. Haematologica 2012;97(10):1603-7. (In eng). DOI: 10.3324/haematol.2012.064444.

Schoen MW, Carson KR, Luo S, et al. Venous thromboembolism in multiple myeloma is associated with increased mortality. Res Pract Thromb Haemost 2020;4(7):1203-1210. (In eng). DOI: 10.1002/rth2.12411.

Bradbury CA, Craig Z, Cook G, et al. Thrombosis in patients with myeloma treated in the Myeloma IX and Myeloma XI phase 3 randomized controlled trials. Blood 2020;136(9):1091-1104. (In eng). DOI: 10.1182/blood.2020005125.

Becattini C, Verso M, Mu?oz A, Agnelli G. Updated meta-analysis on prevention of venous thromboembolism in ambulatory cancer patients. Haematologica 2020;105(3):838-848. (In eng). DOI: 10.3324/haematol.2019.221424.

Di Nisio M, Porreca E, Candeloro M, De Tursi M, Russi I, Rutjes AW. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev 2016;12(12):Cd008500. (In eng). DOI: 10.1002/14651858.CD008500.pub4.

Carrier M, Abou-Nassar K, Mallick R, et al. Apixaban to Prevent Venous Thromboembolism in Patients with Cancer. The New England journal of medicine 2019;380(8):711-719. (In eng). DOI: 10.1056/NEJMoa1814468.

Khorana AA, Soff GA, Kakkar AK, et al. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. The New England journal of medicine 2019;380(8):720-728. (In eng). DOI: 10.1056/NEJMoa1814630.

Streiff MB, Holmstrom B, Angelini D, et al. NCCN Guidelines Insights: Cancer-Associated Venous Thromboembolic Disease, Version 2.2018. Journal of the National Comprehensive Cancer Network : JNCCN 2018;16(11):1289-1303. (In eng). DOI: 10.6004/jnccn.2018.0084.

Baker HA, Brown AR, Mahnken JD, Shireman TI, Webb CE, Lipe BC. Application of risk factors for venous thromboembolism in patients with multiple myeloma starting chemotherapy, a real-world evaluation. Cancer Med 2019;8(1):455-462. (In eng). DOI: 10.1002/cam4.1927.

Sanfilippo KM, Fiala MA, Tathireddy H, Feinberg D, Vij R, Gage BF. D-Dimer Improves Risk Prediction of Venous Thromboembolism in Patients with Multiple Myeloma.  BLOOD: AMER SOC HEMATOLOGY 2021 L ST NW, SUITE 900, WASHINGTON, DC 20036 USA; 2020.

Kumar SK, Jacobus SJ, Cohen AD, et al. Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial. The lancet oncology 2020;21(10):1317-1330. (In eng). DOI: 10.1016/s1470-2045(20)30452-6.

Moreau P, Attal M, Hulin C, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet 2019;394(10192):29-38. (In eng). DOI: 10.1016/s0140-6736(19)31240-1.

Durie BGM, Hoering A, Abidi MH, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet 2017;389(10068):519-527. (In eng). DOI: 10.1016/s0140-6736(16)31594-x.

Yoshida K, Hernndez-Daz S, Solomon DH, et al. Matching Weights to Simultaneously Compare Three Treatment Groups: Comparison to Three-way Matching. Epidemiology 2017;28(3):387-395. (In eng). DOI: 10.1097/ede.0000000000000627.

Breiman L. Random forests. Machine learning 2001;45(1):5-32.

Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Statistics in medicine 2009;28(25):3083-107. (In eng). DOI: 10.1002/sim.3697.
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pi country
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pi affil
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}


products
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num of trials
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res
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}