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      string(172) "NCT03277105 - A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma"
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  ["project_title"]=>
  string(143) "Comparison of the time course of treatment-emergent Grade 3/4 and serious adverse events for daratumumab SC vs. IV in the Phase 3 COLUMBA trial"
  ["project_narrative_summary"]=>
  string(852) "Antibody cancer drugs are most often given through an IV pump at a hospital or outpatient clinic. However, they can also be given under the skin, also called “subcutaneous” (SC) dosing, which takes much less time to administer than IV and potentially causes fewer reactions to the drug. One of these drugs, daratumumab is approved to treat multiple myeloma, a rare blood cancer, and both IV (DARZALEX) and SC routes (DARZALEX FASPRO) were directly compared in a clinical trial (named COLUMBA). We are researching whether SC daratumumab is safer than the IV version in myeloma patients and how long after dosing any severe or life-threatening safety issues arise with either form of the drug. This will help us to understand more fully the potential benefits of giving daratumumab and other cancer therapies via the SC route instead of the IV route."
  ["project_learn_source"]=>
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    string(7) "Charles"
    ["last_name"]=>
    string(6) "Theuer"
    ["degree"]=>
    string(7) "MD, PhD"
    ["primary_affiliation"]=>
    string(27) "Halozyme Therapeutics, Inc."
    ["email"]=>
    string(20) "ctheuer@halozyme.com"
    ["state_or_province"]=>
    string(2) "CA"
    ["country"]=>
    string(13) "United States"
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      ["p_pers_pr_affil"]=>
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    ["label"]=>
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  ["project_date_type"]=>
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  ["property_scientific_abstract"]=>
  string(96) "Please see the Supplementary Materials for the full Scientific Abstract for the proposed study. "
  ["project_brief_bg"]=>
  string(847) "These data will be used to inform clinicians, policy makers, and patients on potential safety differences between the SC and IV ROA for daratumumab, allowing optimized care for patients with multiple myeloma. Along with the planned inclusion of safety data over time for other antibodies in our published research, these findings could more broadly inform the public of the overall advantages and benefits of SC dosing compared to the IV ROA. If SC dosing of antibody-based therapies is consistently shown to provide safety benefits along with previously demonstrated humanistic and economic benefits versus IV dosing (Anderson et al. Future Oncol 2019, Epstein Clinicoecon Outcomes Res 2021, McCloskey et al Pharmacoecon Open 2023), this would spur the development of safer and more convenient SC formulations of existing and emerging therapies. "
  ["project_specific_aims"]=>
  string(1084) "•	The study objective is to characterize the time course of 1) Grade 3 (G3) / Grade 4 (G4) treatment-emergent adverse events (TEAEs), 2) treatment-related G3/G4 TEAEs, 3) serious TEAEs and 4) serious treatment-related TEAEs for daratumumab SC compared to daratumumab IV in patients with relapsed or refractory multiple myeloma in the COLUMBA trial.

•	The specific hypothesis is that daratumumab SC has a less frequent occurrence of G3/G4 TEAEs, treatment-related G3/G4 TEAEs, serious TEAEs and treatment-related serious TEAEs over the time course of treatment than for daratumumab IV.

•	The data from the COLUMBA trial will be compared descriptively with similar and separate analyses of the occurrence of adverse events over time from Phase 3 randomized non-inferiority clinical trials comparing SC and IV for two other antibodies (nivolumab [NCT04810078] and atezolizumab [NCT03735121]) to generate a clearer picture of the relative safety benefits of the SC route of administration (ROA) compared to the IV ROA in patients with hematologic or solid malignancies"
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    ["label"]=>
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      ["value"]=>
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      ["label"]=>
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  ["project_research_methods"]=>
  string(1570) "Individual patient-level data from NCT03277105: A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma (COLUMBA)

1.	Time to Onset (# days between the randomization date and the start date of the first event) of Grade 3 / Grade 4 treatment-emergent adverse events (TEAEs)

2.	Time to Onset (# days between the randomization date and the start date of the first event) of serious TEAEs

3.	Time to Onset (# days between the randomization date and the start date of the first event) of treatment-related Grade 3 / Grade 4 TEAEs

4.	Time to Onset (# days between the randomization date and the start date of the first event) of treatment-related serious TEAEs

5.	Duration (# of study days from event onset to resolution) of Grade 3 / Grade 4 TEAEs

6.	Duration (# of study days from event onset to resolution) of serious TEAEs

7.	Duration (# of study days from event onset to resolution) of treatment-related Grade 3 / Grade 4 TEAEs

8.	Duration (# of study days from event onset to resolution) of treatment-related serious TEAEs

9.	Duration of follow-up (# days from randomization to study end or study discontinuation)

10.	Reason for discontinuation (e.g., progressive disease, adverse events, patient withdrawal, physician decision, death, or other reason)



Population will include all patients in the safety-evaluable population from the COLUMBA study (n=260 for daratumumab SC, n=258 for daratumumab IV). "
  ["project_main_outcome_measure"]=>
  string(732) "•	The primary endpoint is the occurrence of Grade 3 / Grade 4 treatment emergent AEs (TEAEs) over time between patients dosed with daratumumab SC vs. daratumumab IV in the Phase III COLUMBA trial.  

•	Secondary endpoints include:

1.	The occurrence of treatment-related Grade 3 / Grade 4 TEAEs over time between patients dosed with daratumumab SC vs. daratumumab IV in the Phase III COLUMBA trial.

2.	The occurrence of serious TEAEs over time between patients dosed with daratumumab SC vs. daratumumab IV in the Phase III COLUMBA trial.

3.	The occurrence of treatment-related serious TEAEs over time between patients dosed with daratumumab SC vs. daratumumab IV in the Phase III COLUMBA trial.

"
  ["project_main_predictor_indep"]=>
  string(62) "Route of administration (SC, IV) is the Independent Variable. "
  ["project_other_variables_interest"]=>
  string(204) "Stratification factors will include:

•	Baseline body weight (≤65 kg, 66-85 kg, >85 kg)

•	Previous lines of treatment (≤four vs. >four)

•	Myeloma type (IgG vs. non-IgG)"
  ["project_stat_analysis_plan"]=>
  string(841) "Regression models will be used to estimate distributions and compare differences between routes of administration for time-to-event of (1) Grade 3 (G3) / Grade (G4) treatment-emergent adverse events (TEAEs), (2) treatment-related G3/G4 TEAEs, (3) serious TEAEs, and (4) treatment-related serious TEAEs.  Time to event onset will be calculated as the days between randomization date and start date of first event. The Grade 3/4 TEAE categories will include only highest grade TEAE of patients with grade 3/4 TEAEs to avoid double-counting. Hazard ratios and 95% confidence intervals will be estimated using a stratified Cox proportional hazard regression model. Stratification factors will be baseline body weight (85 kg), previous lines of treatment (four), and myeloma type (IgG vs non-IgG). R will be used to perform statistical analyses. "
  ["project_software_used"]=>
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    [0]=>
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      ["value"]=>
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      ["label"]=>
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  ["project_timeline"]=>
  string(467) "•	Project completion is estimated within 1 year of data availability

•	Completion of contract: August 17, 2025

•	Delivery of de-identified dataset: September 2025

•	Data analysis: September-November 2025

•	Date Manuscript drafted and first submitted for publication: December 2025 / January 2026

•	Draft and circulate abstract (potentially ASCO 2026): January 2026

•	Date report submitted to YODA: February 2026"
  ["project_dissemination_plan"]=>
  string(266) "Abstract to be submitted to a major international clinical oncology or hematology meeting. 

Manuscript to be submitted to a clinical oncology journal (e.g., Journal of Clinical Oncology or Clinical Cancer Research) or a more general journal to be determined. "
  ["project_bibliography"]=>
  string(1706) "
1. Aguiar-Ibáñez R, Fotheringham I, Mittal L, Sillah A, Pathak S. Differences Between Intravenous and Subcutaneous Modes of Administration in Oncology from the Patient, Healthcare Provider, and Healthcare System Perspectives: A Systematic Review. Adv Ther. 2024;41(12):4396-4417. doi:10.1007/s12325-024-02985-9

2. Usmani SZ, Nahi H, Legiec W, et al. Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma. Haematologica. 2022;107(10):2408-2417. Published 2022 Oct 1. doi:10.3324/haematol.2021.279459

3. Mateos MV, Nahi H, Legiec W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial [published correction appears in Lancet Haematol. 2020 Oct;7(10):e710. doi: 10.1016/S2352-3026(20)30296-9.]. Lancet Haematol. 2020;7(5):e370-e380. doi:10.1016/S2352-3026(20)30070-3

4. Anderson KC, Landgren O, Arend RC, Chou J, Jacobs IA. Humanistic and economic impact of subcutaneous versus intravenous administration of oncology biologics. Future Oncol. 2019;15(28):3267-3281. doi:10.2217/fon-2019-0368

5. Epstein RS. Payer Perspectives on Intravenous versus Subcutaneous Administration of Drugs. Clinicoecon Outcomes Res. 2021;13:801-807. doi:10.2147/CEOR.S317687

6. McCloskey C, Ortega MT, Nair S, Garcia MJ, Manevy F. A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting. Pharmacoecon Open. 2023;7(1):3-36. doi:10.1007/s41669-022-00361-3
"
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    string(42) "yoda-project-protocol-2025-0532-2025-07-22"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(17634)
    ["date"]=>
    string(19) "2025-09-18 13:55:28"
    ["modified"]=>
    string(19) "2025-09-18 13:55:28"
    ["menu_order"]=>
    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
    ["type"]=>
    string(11) "application"
    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_review_link"]=>
  array(21) {
    ["ID"]=>
    int(17941)
    ["id"]=>
    int(17941)
    ["title"]=>
    string(36) "YODA Project Review - 2025-0532_site"
    ["filename"]=>
    string(38) "YODA-Project-Review-2025-0532_site.pdf"
    ["filesize"]=>
    int(1315473)
    ["url"]=>
    string(87) "https://yoda.yale.edu/wp-content/uploads/2025/07/YODA-Project-Review-2025-0532_site.pdf"
    ["link"]=>
    string(80) "https://yoda.yale.edu/data-request/2025-0532/yoda-project-review-2025-0532_site/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1885"
    ["description"]=>
    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(34) "yoda-project-review-2025-0532_site"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(17634)
    ["date"]=>
    string(19) "2025-09-18 13:55:53"
    ["modified"]=>
    string(19) "2025-09-18 13:55:53"
    ["menu_order"]=>
    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
    ["type"]=>
    string(11) "application"
    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_highlight_button"]=>
  string(0) ""
  ["request_data_partner"]=>
  string(0) ""
}
data partner
array(1) {
  [0]=>
  string(0) ""
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(0) {
}


num of trials
array(1) {
  [0]=>
  string(1) "0"
}


res
array(1) {
  [0]=>
  string(1) "3"
}