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  ["property_scientific_abstract"]=>
  string(1621) "Background: Multiple myeloma (MM) is an incurable malignancy that is associated with a significant infectious risk, particularly among patients treated with the anti-CD38 monoclonal antibody daratumumab, though it is unknown how the infectious risk changes over time. 

Objective: Characterize the trajectory of infectious risk over time in patients with MM treated with daratumumab-containing regimens.

Study Design: Meta-analysis of available clinical trials on the YODA registry

Population: Patients with MM treated with daratumumab-containing regimens will be included 

Primary Outcomes: Describe the trajectory of infections (grade ≥1 or higher and any type of infection) within the first 2 years of daratumumab treatment. 

Secondary outcomes: Characterize the trajectory of infections based on the frailty status of patients, the severity of infections, and the rates of respiratory infections, specifically. The type of infectious complications (organ involvement, type of microbe) and the proportion of patients with recurrent infections will be presented. The association between antibacterial prophylaxis and subsequent infection risk will be studied. 

Statistical Analysis: The study outcomes will be analyzed descriptively. The rates of infection (number of infectious episodes divided by the total person-months of daratumumab treatment) will be assessed in 3-month intervals and displayed graphically to show the infection rate over time. Logistic regression will be used to study the association between antibiotic prophylaxis use and the 1-year risk of infection"
  ["project_brief_bg"]=>
  string(1399) "Patients with multiple myeloma (MM) have a 7-10 fold increase in the risk of infections compared to age-matched controls (1) due to both immunoparesis in the setting of active malignancy, but also due to the immunosuppressive treatments. The routine incorporation of anti-CD38 monoclonal antibodies (mAbs), such as daratumumab, has further increased the infection risk. A systematic review of patients treated on clinical trials has shown that patients treated with anti-CD38 monoclonal antibody (mAb) have a 27% increased risk of infections, and a 39% increased risk of pneumonia, compared to patients treated without anti-CD38 mAbs (3). However, these studies assume that the risk of infection remains constant over time, and no prior studies have characterized the trajectory of infections over time. This is particularly relevant given that the current paradigm is for patients remain on daratumumab treatment as long as the disease is detectable or until disease progression (4, 5). While antimicrobial prophylaxis or immunoglobulin replacement may mitigate infection risk, it’s unclear how and when to implement these prophylaxis strategies. Therefore, this study will provide data on the time-period and patient characteristics that are associated with the highest risk of infection, so that future studies can be designed to implement and study effective infection prophylaxis strategies. "
  ["project_specific_aims"]=>
  string(1171) "The primary aim will be to characterize the trajectory of infections within the first 2 years of treatment, among patients with multiple myeloma treated on clinical trial with a daratumumab-containing regimen. The hypothesis is that the study will identify the frequency and time-period when patients are at greatest risk of infection. 



The secondary aims will be to characterize infection trajectories among specific subgroups of the patient populations to identify the infectious risk among the most vulnerable patients (i.e. frail and elderly patients), and to further elucidate the severity and types of infections. We hypothesize that the infection risk will be higher among frail versus non-frail patients, that the rate of severe infections will higher within the first 6 months of treatment (when patients are on weekly or biweekly dosing of daratumumab), and that respiratory infections will be most frequent. We will also assess whether the use of antibacterial prophylaxis reduces the 1-year infection risk, and hypothesize that patients with versus without antibacterial prophylaxis will have a significant reduction in infection risk. 

"
  ["project_study_design"]=>
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    ["label"]=>
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      ["label"]=>
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  ["project_research_methods"]=>
  string(484) "Individual patient-level data provided through the YODA project will be used for this study. 



Inclusion criteria:

1.	Receipt of >1 dose of a daratumumab-containing regimen 

2.	Safety data available in the provided dataset 



Exclusion criteria:

1.	Received a non-daratumumab treatment (control arm or patients randomized to the intervention arm that did not receive treatment)

2.	Diagnosis of systemic AL amyloidosis 

"
  ["project_main_outcome_measure"]=>
  string(1230) "Primary: Characterize the of infections trajectory within the first 2 years of daratumumab treatment.



Secondary:

1.	Characterizing infection patterns: A) Evaluate the infection trajectories based on baseline frailty status (using the modified frailty score [1]), infection severity (grade 1-2 vs ≥3), disease status (new versus relapsed refractory myeloma), type of infection (respiratory vs other), month of treatment initiation among patients in North America (October-March versus April-September, to account for seasonal respiratory virus variations); B) summarize the type of infectious complications (organ involvement, type of microbe); C)Quantify the proportion of patients with recurrent serious infection (defined as >1 grade ≥3 infection within 2 years); D) Characterize the median polyclonal IgG component over time among patients still on treatment with daratumumab.

2.	Evaluating the role of infectious prophylaxis and subsequent infection: Identify the association between antibiotic exposure (defined as any antimicrobial started within 2 weeks of treatment initiation) and infection risk at 1 year post treatment (adjusting for age, baseline comorbidity index, and ECOG status)"
  ["project_main_predictor_indep"]=>
  string(701) "The main predictor will be reported infectious complications, as defined in the common terminology criteria for adverse events (CTCAE) version 5.0 (updated November 27, 2017). Any infectious adverse event (regardless of whether the investigator attributed the adverse event to treatment) will be included, and a summary of infectious terms can be found in the supplementary appendix. To better characterize the severity and type of infections (particularly given the risk of sinopulmonary infections with daratumumab), CTCAE terms will also be analyzed based on the grading severity (grade 1 to 5) and based on terms considered to include respiratory infections (summarized in the attached appendix). "
  ["project_other_variables_interest"]=>
  string(1236) "	Baseline demographic variables to be presented in table 1: Age at treatment initiation (continuous), sex (male vs female), country of residence (to show the generalizability of treatment)

	Month of treatment initiation 

	Disease status (newly diagnosed with no prior treatment and relapsed/refractory if >1 prior treatment line)

	Frailty status will be defined using the simplified frailty score which incorporates the baseline age, Charlson comorbidity index, ECOG performance status, and defines frail as patients with a score ≥2 (6)

	Recurrent infections – will be defined as the occurrence of a subsequent CTCAE infectious event that is either different to the prior event, or is the same infection occurring >4 weeks after the initial infectious episode. 

	Exposure to antibiotic prophylaxis will be defined as the use of either septra (also known as Bactrim or Sulfamethoxazole/trimethoprim) or a fluoroquinolone (levofloxacin or moxifloxacin) within 2 weeks of the regimen start date, and for a duration of >4 weeks. Those patients who are treated with another antibiotic within 1 week of antibiotic prophylaxis exposure will be considered to have an infection. "
  ["project_stat_analysis_plan"]=>
  string(1587) "Data will be analyzed descriptively and presented graphically. The risk of infection will be assessed in three month intervals from the initiation of treatment until either the last follow up, or 2 years post treatment, whichever occurs first. Within each 3-month interval, the total number of infections will be divided by the total number of person-months of treatment on daratumumab (to account for attrition during the study follow up). Patients with multiple infectious episodes during the time-period will be counted multiple times. Then, the infections per person months within each 3-month interval will be shown graphically (see supplementary figure 1 for a visual representation of the planned output). Given that the high-risk of febrile neutropenia and infectious complications post autologous stem cell transplantation (ASCT) is related to the melphalan conditioning rather than daratumumab exposure, data from patients with newly diagnosed multiple myeloma undergoing ASCT will not be included from the date of ASCT and until 90 days post ASCT. Similar figures will be shown the characterize the trajectory of infections for each of the planned secondary outcomes. 



A logistic regression model will be used to evaluate the association between antibiotic prophylaxis exposure and the outcome of infection by 1 year of treatment or follow-up, adjusting for baseline age, comorbidity index, and ECOG performance status. Given the risk of ASCT-related infection within the first year of treatment, patients treated with ASCT will be excluded from this analysis. "
  ["project_software_used"]=>
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    ["label"]=>
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  ["project_timeline"]=>
  string(324) "-	February 1, 2025: project start date

-	February 1, 2025 - July 31, 2025: data analysis

-	August 2025: Abstract submission to the American Society of Hematology Annual Conference

-	December 1, 2025: First manuscript draft complete 

-	January 31, 2026: First manuscript submitted for publication "
  ["project_dissemination_plan"]=>
  string(469) "Our plan is to submit an abstract in August 2025 for presentation at the American Society of Hematology Annual Conference in December 2025. We aim to have a first draft of the manuscript completed by December 2025. The target audience of this manuscript is malignant hematologists, and so potential journals for manuscript submission include Blood Cancer Journal, Blood Advances, the American Journal of Hematology, the British Journal of Hematology, or Haematologica. "
  ["project_bibliography"]=>
  string(1205) "

Blimark C, Holmberg E, Mellqvist UH, Landgren O, Björkholm M, Hultcrantz M, et al. Multiple myeloma and infections: a population-based study on 9253 multiple myeloma patients. Haematologica. 2015;100(1):107-13.
Vassilopoulos S, Vassilopoulos A, Kalligeros M, Shehadeh F, Mylonakis E. Cumulative Incidence and Relative Risk of Infection in Patients With Multiple Myeloma Treated With Anti-CD38 Monoclonal Antibody-Based Regimens: A Systematic Review and Meta-analysis. Open Forum Infectious Diseases. 2022;9(11).
Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, et al. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019;380(22):2104-15.
Sonneveld P, Dimopoulos MA, Boccadoro M, Quach H, Ho PJ, Beksac M, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024;390(4):301-13.
Facon T, Dimopoulos MA, Meuleman N, Belch A, Mohty M, Chen W-M, et al. A simplified frailty scale predicts outcomes in transplant-ineligible patients with newly diagnosed multiple myeloma treated in the FIRST (MM-020) trial. Leukemia. 2020;34(1):224-33.

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