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      ["post_title"]=>
      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(192) "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-ineligi"
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      ["post_modified"]=>
      string(19) "2025-10-28 13:18:09"
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      string(241) "https://dev-yoda.pantheonsite.io/clinical-trial/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-ineligi/"
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  ["project_title"]=>
  string(132) "Real-World Data-based External Control arms and Real-World Effectiveness of Dara-Rd and Rd in Transplant-Ineligible Multiple Myeloma"
  ["project_narrative_summary"]=>
  string(817) "Multiple myeloma (MM) is a malignant plasma cell disorder and is the second most common type of blood cancer.  In the past decade, many new treatments have become available for patients with MM, leading to a rapidly evolving standard of care. This challenges the feasibility of clinical trials. Therefore, Real-World Data (RWD) is increasingly used to provide a comparison group for clinical trials. In addition, RWD on effectiveness and safety is important to realistically inform patients’ and clinicians’ treatment decisions in clinical practice. In this study, we will compare characteristics and outcomes of patients diagnosed with MM and treated with daratumumab, lenalidomide and dexamethasone (D-Rd) in the real-world setting in the Netherlands with those treated within the phase 3 randomized MAIA trial."
  ["project_learn_source"]=>
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    ["first_name"]=>
    string(5) "Sonja"
    ["last_name"]=>
    string(8) "Zweegman"
    ["degree"]=>
    string(6) "MD/PhD"
    ["primary_affiliation"]=>
    string(13) "Amsterdam UMC"
    ["email"]=>
    string(26) "s.zweegman@amsterdamumc.nl"
    ["state_or_province"]=>
    string(13) "Noord Holland"
    ["country"]=>
    string(15) "The Netherlands"
  }
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      ["p_pers_f_name"]=>
      string(4) "Anna"
      ["p_pers_l_name"]=>
      string(4) "Smit"
      ["p_pers_degree"]=>
      string(3) "Msc"
      ["p_pers_pr_affil"]=>
      string(33) "Erasmus University Medical Center"
      ["p_pers_scop_id"]=>
      string(11) "59998276900"
      ["requires_data_access"]=>
      string(3) "yes"
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      ["p_pers_f_name"]=>
      string(6) "David "
      ["p_pers_l_name"]=>
      string(6) "Cucchi"
      ["p_pers_degree"]=>
      string(6) "MD/PhD"
      ["p_pers_pr_affil"]=>
      string(33) "Erasmus University Medical Center"
      ["p_pers_scop_id"]=>
      string(11) "56422285700"
      ["requires_data_access"]=>
      string(3) "yes"
    }
  }
  ["project_ext_grants"]=>
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    ["value"]=>
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    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
  }
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1680) "Background

Real-world data (RWD) is increasingly used for external control arms to supplement treatment arms in clinical trials. However, validity depends on data quality and comparability to trial populations. The Netherlands Cancer Registry (NCR) developed an automated data extraction system, enabling capture of RWD for external controls.

RWD is also essential to assess real-world effectiveness. In non-transplant-eligible patients with multiple myeloma (NTE MM), daratumumab-lenalidomide-dexamethasone (Dara-Rd) is currently standard first-line therapy, yet RWD on the effectiveness and toxicity of Dara-Rd versus Rd is lacking.

Objective

To assess: (1) whether RWD-based external control arms can be used to supplement treatment arms in clinical trials; and (2) real-world effectiveness and toxicity of Dara-Rd versus Rd in NTE MM patients with comparison to the MAIA trial.

Study Design

Patients from the MAIA trial will be matched with patients from the NCR treated with Dara-Rd and Rd. Efficacy and safety outcomes will be compared between real-world and trial populations.

Participants

Newly diagnosed NTE MM patients treated with Dara-Rd and Rd between 2020-2026 in the Netherlands, sourced from the NCR, are included in the study. 

Primary and Secondary Outcome Measure(s)

Outcomes include time to next treatment (TTNT), overall survival (OS), progression-free survival (PFS) and time to treatment discontinuation.

Statistical Analysis

Patients will be matched using propensity-score matching. TTNT, OS and PFS will be analyzed using Kaplan-Meier and Cox proportional hazards models."
  ["project_brief_bg"]=>
  string(3239) "Project background

Multiple myeloma (MM) is a plasma cell malignancy associated with substantial morbidity and mortality, with survival improvements remaining limited in older, non transplant eligible (NTE) patients. 

In the past decade, the therapeutic landscape for patients with MM has rapidly expanded. Consequently, the standard of care defined at the time of trial initiation may no longer represent the standard by the time randomized controlled trials (RCTs) reach readout. This challenges the feasibility and clinical relevance of RCTs. Therefore, external control data are increasingly used to supplement treatment arms and as external control arms in single-arm trials in settings where RCTs are not feasible (1).

At present, external control arms using Real-World Data (RWD) have significant limitations in terms of data availability and quality, differences in patient selection and missing toxicity and follow-up data (2,3). An automated electronic health record-data extraction system has been developed and validated by the Netherlands Cancer Registry (NCR) and our team to capture patient characteristics and follow-up data related to effectiveness, toxicity and treatment regimens (4). Using this system, RWD can be captured for the use of external controls. However, the question remains whether these data are of sufficient quality, how patients from the real-world (RW) population compare with the patients treated in a RCT, and whether they can be used as external controls.

If of sufficient quality, RWD can also be used to compare trial efficacy with RW effectiveness and identify opportunities to improve care in daily clinical practice. For NTE-NDMM, the current standard of care for first-line therapy is daratumumab-lenalidomide-dexamethasone (Dara-Rd), based on superior progression-free and overall survival versus Rd as demonstrated by the phase III MAIA trial (5). However, since reimbursement in 2023, treatment of potentially eligible patients has plateaued at ~75% in the Netherlands, particularly in older and frailer patients, where Rd or alternative regimens are still frequently selected. Reasons might include fear for higher toxicity or lower efficacy of Dara-Rd in RW than in the trial population, potentially leading to unwanted treatment variation. RWD on effectiveness and toxicity of Dara-Rd versus Rd in routine care could address these issues but are currently lacking.



Project significance

Designing RCTs in rare cancers presents an enormous challenge for researchers, regulators, and other stakeholders(3). This urged the oncology research community to consider RWD to construct external control arms for clinical trials. This project will contribute to the methodological foundation for using RWD in clinical trials and aims to serve as proof-of-concept for automated data extraction to construct high-quality external controls with the potential to be applied in future prospective trials in hemato-oncology.

Furthermore, RWD on the effectiveness and toxicity of Dara-Rd and Rd in unselected, routine-care populations will support patients and physicians to choose the most effective and appropriate treatment option for NTE NDMM."
  ["project_specific_aims"]=>
  string(498) "This study aims to address the following questions:

1.	To what extent can RWD-based external control arms be used to supplement treatment arms in clinical trials; and how do external control arm patients treated in the real-world compare with patients treated in the MAIA trial?

2.	What are the real-world effectiveness and toxicity of Dara-Rd compared with Rd in Dutch transplant-ineligible newly diagnosed MM patients, and how do these compare with data from the MAIA trial?

"
  ["project_study_design"]=>
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    ["value"]=>
    string(8) "meth_res"
    ["label"]=>
    string(23) "Methodological research"
  }
  ["project_purposes"]=>
  array(2) {
    [0]=>
    array(2) {
      ["value"]=>
      string(34) "research_on_clinical_trial_methods"
      ["label"]=>
      string(34) "Research on clinical trial methods"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(28) "research_on_comparison_group"
      ["label"]=>
      string(28) "Research on comparison group"
    }
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  ["project_research_methods"]=>
  string(1676) "Inclusion/Exclusion Criteria

MAIA trial data (NCT02252172): No exclusion criteria.



Real-world dataset:						

Inclusion criteria: First-line transplant-ineligible MM patients diagnosed in the Netherlands between 2020-2026, treated with daratumumab, lenalidomide and dexamethasone (D-Rd) or lenalidomide and dexamethasone (Rd).

 

Data Source

The real-world dataset will be obtained from the following two registries: Netherlands Cancer Registry (NCR), Netherlands Comprehensive Cancer Organisation (IKNL) and from Dutch Hospital Data (DHD). 					



Netherlands Cancer Registry

The NCR compiles clinical data of all individuals newly diagnosed with cancer in the Netherlands. Cancer registration data managers register newly diagnosed cancer patients since 1989 on a national basis. This registry provides clinicians and academic researchers with clinical data (e.g., stage, primary treatment, baseline characteristics and clinical outcomes) of patients with cancer in the Netherlands.



Dutch Hospital Data (DHD)

DHD registers hospital activity, procedures and complications, and monitors use of expensive drugs in the Netherlands (Medicines Monitor). 

Both registries are active, and sustainability is ensured by national funding, and integration into healthcare monitoring for the government. The use of NCR and DHD data is covered by national legal frameworks and registry governance.



IPD analysis will be performed within the secure platform and the anonymized real-world dataset will be uploaded as additional data set to the secure platform for IPD analysis. "
  ["project_main_outcome_measure"]=>
  string(1849) "Primary  outcome:

•Time to next treatment (TTNT). Time to next treatment is defined as time from randomization to the start of the next-line treatment.



Secondary outcomes:

Time-to-event endpoints

•Overall survival (OS). Overall survival is defined as the time from randomization to death. 

•Progression-free survival (PFS). Progression-free survival is defined as the time from randomization to disease progression or death, whichever came first. Disease progression is defined in accordance with the International Myeloma Working Group criteria.



Response

•Response first line therapy. Response is defined in accordance with the International Myeloma Working Group criteria.



Treatment discontinuation

•Time to treatment discontinuation

•Treatment duration 

•Early (≤3, ≤9 months) treatment discontinuation rate

•Reason for treatment discontinuation



Health Related Quality of Life (HRQOL) as defined by: 

-	EORTC QLQ-C30

-	EQ5D



Safety data: 

Adverse events Grade 3 and 4 categories as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 

Hematologic adverse events

Anaemia; Neutropenia; Leukopenia; Febrile neutropenia; Thrombocytopenia; Lymphopenia

Non-hematologic adverse events

Infections - Respiratory;   Infection - Pneumonia;   Infections - Sepsis;   Infections - COVID19;   Infections - Other;   Peripheral sensory neuropathy;  Pyrexia;   Vascular events - Arterial embolism and   thrombosis;   Vascular events - Venous embolism and   thrombosis;   Vascular events - Pulmonary embolism;   Vascular events - Deep vein thrombosis;   Myocardial infarction;    Acute renal failure;   Second primary malignancy"
  ["project_main_predictor_indep"]=>
  string(199) "Independent variables will include 

•	age, International Staging System (ISS) disease stage, cytogenetic profile, and Eastern Cooperative Oncology Group performance status (ECOG PS).

"
  ["project_other_variables_interest"]=>
  string(229) "Other variables of interest will include: 

•	 sex, frailty status, type of measurable disease, creatinine clearance at baseline (CrCl), median time since initial diagnosis of MM, Charlson Comorbidity Index (CCI).

"
  ["project_stat_analysis_plan"]=>
  string(1341) "Baseline characteristics and safety data will be summarized using descriptive statistics. Group comparisons for baseline characteristics and safety data will be performed using independent samples t-test for normally distributed variables, Mann–Whitney U test for non-normally distributed variables, or Chi-square test, as appropriate. 



Time-to-event outcomes will be analyzed using Kaplan-Meier and Cox proportional hazards regression models, including time-to-next treatment (TTNT), overall survival (OS), progression-free survival (PFS) and time-to-treatment discontinuation (TTD).



Patients from the MAIA experimental and control arms will be matched using nearest neighbor propensity-score matching with patients from the Netherlands Cancer Registry real-world dataset. Caliper width will be applied based on standard deviation of the propensity score. Propensity-score matching variables will include age, ISS disease stage, cytogenetic risk and ECOG-PS. Strength of residual confounding will be assessed using E-values and alternative matching methods will be applied as appropriate.			



Missing data will be assessed for MCAR/MAR/NMAR. Multiple imputation for plausibly MAR variables will be applied, and sensitivity analyses will be performed (complete- case/alternative models).

"
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      ["label"]=>
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  ["project_timeline"]=>
  string(514) "Project Timeline

•	January 2026 – Project initiation.

•	March 2026 – Receipt data from Netherlands Cancer Registry (Data delivered March 10, 2026).

•	March - April 2026 – Data request and acquisition from the YODA Project (MAIA trial data).

•	Q2 2026 – Data analysis.

•	July 2026 - Analysis completion.

•	Q3-Q4 2026 – Manuscript preparation and submission for publication.

•	December 2026 - Results reported back to the YODA Project.

"
  ["project_dissemination_plan"]=>
  string(521) "The completed research study will be presented at national and international conferences and published in peer-reviewed manuscripts. Potential journals include Hemasphere; British Journal of Hematology; Haematologica; Cancer Medicine and Blood Advances. Potential conferences where the completed research study will be presented include European Myeloma Network Annual Meeting, European Hematology Association Annual Meeting, International Myeloma Society Annual Meeting and American Society of Hematology Annual Meeting."
  ["project_bibliography"]=>
  string(1964) "

Hermans, S. J. F., Versluis, J., van Werkhoven, E. D., van Norden, Y., Janssen, J. J. W. M., Huls, G. A., Pabst, T., Breems, D. A., Berkx, E., Dinmohamed, A. G., Huijgens, P. C., Sträng, E., Hernández Rivas, J. M., Sobas, M., Ayala Diaz, R., Martinez Lopez, J., Metzeler, K. H., Haferlach, T., Thiede, C., Uyl-de Groot, C. A., … Cornelissen, J. J. (2026). Comparability of external and internal control patients for the prospective randomized HOVON-103 trial in older AML patients. British journal of haematology, 208(1), 179–188.
Hermans, S. J. F., van der Maas, N. G., van Norden, Y., Dinmohamed, A. G., Berkx, E., Huijgens, P. C., Rivera, D. R., de Claro, R. A., Pignatti, F., Versluis, J., & Cornelissen, J. J. (2024). Externally Controlled Studies Using Real-World Data in Patients With Hematological Cancers: A Systematic Review. JAMA oncology, 10(10), 1426–1436.
Cornelissen, J. J., van Werkhoven, E., & Versluis, J. (2025). Borrowing from the past to test the future: Innovative approaches to prospective clinical trials in rare cancers. European journal of cancer (Oxford, England : 1990), 225, 115536.
Langhout, S. A. M., Hermans, S. J. F., Smit, A. J. T., Berkx, E., Kurk, S. A., Schade, K. J., Posthuma, E. F. M., Visser, O., Cornelissen, J. J., Huijgens, P. C., Versluis, J., van der Wilt, M., & Dinmohamed, A. G. (2025). Real-time data in cancer registries: Validation of an automated data extraction system. iScience, 28(8), 113056.
Facon, T., Moreau, P., Weisel, K., Goldschmidt, H., Usmani, S. Z., Chari, A., Plesner, T., Orlowski, R. Z., Bahlis, N., Basu, S., Hulin, C., Quach, H., O’Dwyer, M., Perrot, A., Jacquet, C., Venner, C. P., Raje, N., Tiab, M., Macro, M., Frenzel, L., … Kumar, S. K. (2025). Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes. Leukemia, 39(4), 942–950.

"
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    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_review_link"]=>
  array(21) {
    ["ID"]=>
    int(19615)
    ["id"]=>
    int(19615)
    ["title"]=>
    string(36) "YODA Project Review - 2026-0260_site"
    ["filename"]=>
    string(38) "YODA-Project-Review-2026-0260_site.pdf"
    ["filesize"]=>
    int(1074853)
    ["url"]=>
    string(87) "https://yoda.yale.edu/wp-content/uploads/2026/04/YODA-Project-Review-2026-0260_site.pdf"
    ["link"]=>
    string(80) "https://yoda.yale.edu/data-request/2026-0260/yoda-project-review-2026-0260_site/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1885"
    ["description"]=>
    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(34) "yoda-project-review-2026-0260_site"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(19099)
    ["date"]=>
    string(19) "2026-07-14 16:29:43"
    ["modified"]=>
    string(19) "2026-07-14 16:29:43"
    ["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"
}