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      string(191) "NCT03548207 - A Phase 1b-2, Open-Label Study of JNJ-68284528, A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Relapsed or Refractory Multiple Myeloma"
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  ["project_title"]=>
  string(116) "Exploring Soluble BCMA as a Biomarker for CAR T-Cell Therapy Outcomes in Multiple Myeloma: Insights from CARTITUDE-1"
  ["project_narrative_summary"]=>
  string(702) "Our study focuses on improving treatment for multiple myeloma, a serious blood cancer, by using a groundbreaking approach called CAR T-cell therapy. This treatment tailors a patient’s own immune cells to better attack the cancer, but it's complex and resource-intensive. We're investigating if a simple blood test for soluble B-cell maturation antigen (sBCMA) can forecast who benefits most from this treatment. Higher or lower sBCMA levels might predict treatment success, offering a way to optimize patient selection. By analyzing CARTITUDE-1 trial data, we hope to validate sBCMA's effectiveness as a marker, potentially transforming patient care and resource use in treating this challenging canc"
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    ["first_name"]=>
    string(6) "Ciara "
    ["last_name"]=>
    string(7) "Freeman"
    ["degree"]=>
    string(10) "MD PhD MSc"
    ["primary_affiliation"]=>
    string(21) "Moffitt Cancer Center"
    ["email"]=>
    string(25) "ciara.freeman@moffitt.org"
    ["state_or_province"]=>
    string(2) "FL"
    ["country"]=>
    string(13) "United States"
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      ["p_pers_degree"]=>
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1683) "Background:

Multiple myeloma, characterized by high relapse rates and limited survival, necessitates innovative treatments. CAR T-cell therapies like ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel) show promise. Soluble B-cell maturation antigen (sBCMA), a cleavage product of the membrane-bound form, has been proposed as a potential biomarker due to its role in myeloma pathogenesis and correlation with disease activity.

Objective:

To validate sBCMA's prognostic value in CAR T-cell therapies for multiple myeloma, using CARTITUDE-1 data and establishing sBCMA as a key biomarker.

Study Design:

A retrospective study of CARTITUDE-1 participants and patients treated with FDA approved CAR-T cell products, validating the role of sBCMA. 

Participants:

Adults with relapsed/refractory multiple myeloma treated with CAR T-cell therapies enrolled on CARTITUDE-1. 

Outcome Measures:

The primary outcome measure is to validate baseline sBCMA levels and progression free survival (PFS).  Secondary outcome measures include overall survival (OS), clinical response rates post-CAR T-cell therapy, incidence and severity of toxicities. 

Statistical Analysis:

Multivariate models will analyze sBCMA's impact on outcomes, adjusting for confounders like age, disease stage, prior treatments, baseline ferritin and extramedullary disease. Kaplan-Meier and log-rank tests will assess PFS and OS by sBCMA levels.

Conclusion:

This study aims to validate the role of sBCMA as a predictive biomarker for clinical outcomes in multiple myeloma patients undergoing CAR T-cell therapy. "
  ["project_brief_bg"]=>
  string(3109) "Multiple myeloma (MM) is a complex hematologic malignancy characterized by the clonal proliferation of malignant plasma cells in the bone marrow, leading to bone destruction, anemia, renal failure, and immunodeficiency. Despite advances in treatment strategies, including stem cell transplantation, immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies, MM remains incurable with most patients relapsing or becoming refractory to treatment. The introduction of Chimeric Antigen Receptor (CAR) T-cell therapies, such as ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel), represents a significant breakthrough, offering hope for patients with relapsed or refractory MM[1-3]. These therapies involve engineering patients' T-cells to target specific antigens on cancer cells, demonstrating remarkable efficacy in clinical trials. However, the response to CAR T-cell therapies varies significantly among patients, and the treatments are associated with severe toxicities such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), necessitating the identification of predictive biomarkers to optimize patient selection and management.

Soluble B-cell maturation antigen (sBCMA) has emerged as a potential biomarker due to its role in MM pathogenesis and its correlation with disease activity[4]. sBCMA is shed from the surface of myeloma cells into the circulation, where its levels have been associated with tumor burden and disease progression[5]. Preliminary studies suggest that high pre-treatment levels of sBCMA may predict better responses to CAR T-cell therapies, offering a non-invasive method to guide therapeutic decisions and potentially predict treatment-related toxicities. However, comprehensive validation of sBCMA's prognostic value across different therapeutic contexts and patient populations is lacking. Our project aims to address this gap by leveraging clinical trial data from the CARTITUDE-1 study. By doing so, we intend to validate sBCMA as a reliable biomarker for predicting clinical outcomes, including response rates, progression-free survival (PFS), overall survival (OS), and the incidence and severity of toxicities in patients with MM undergoing CAR T-cell therapy. This work has the potential to significantly impact the field of MM treatment by enabling more personalized and effective therapeutic strategies, improving patient outcomes, and optimizing the use of healthcare resources.

Furthermore, the findings from this study could contribute to the broader understanding of MM biology and the mechanisms underlying the efficacy and toxicity of CAR T-cell therapies. By elucidating the relationship between sBCMA levels and treatment outcomes, we can enhance our knowledge of MM pathogenesis and immune therapy dynamics, informing the development of future therapies and biomarkers. The insights gained from this work will be disseminated through scientific publications and presentations, aiming to inform clinical practice and public health strategies for managing MM. "
  ["project_specific_aims"]=>
  string(1172) "Aim 1: Validate sBCMA's Prognostic Value 

Objective: Determine if pre-treatment sBCMA levels predict clinical outcomes in MM patients undergoing CAR T-cell therapy.

Hypothesis: Higher sBCMA levels before treatment are linked to improved progression-free survival (PFS), better responses, and enhanced overall survival (OS).

Aim 2: Correlate sBCMA with Treatment Toxicities

Objective: Investigate how pre-treatment sBCMA levels relate to CAR T-cell therapy toxicities, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and prolonged cytopenias.

Hypothesis: Elevated sBCMA levels raise the risk of severe toxicities, aiding in risk stratification and CAR T-cell therapy management in MM.

Achieving these aims will validate sBCMA in tailoring CAR T-cell therapy for MM, potentially making treatment more effective and safer. This study's outcomes could profoundly affect clinical practice, allowing healthcare providers to identify patients likely to respond well to CAR T-cell therapies and those at higher toxicity risk, thus optimizing treatment decisions and patient care."
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      ["label"]=>
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      ["value"]=>
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      ["label"]=>
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    }
    [3]=>
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      ["value"]=>
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      ["label"]=>
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  ["project_research_methods"]=>
  string(926) "Single-arm analysis of CARTITUDE-1 data of trial patients with RRMM treated with cilta-cel. Individual trial analysis. 

Research Methods:

We will perform a retrospective analysis, focusing on pre-treatment baseline sBCMA levels, survival outcomes, responses, incidence and severity of toxicities and employing regression models for statistical analysis. 

Software to be used:

Statistical analyses will be conducted using R and Python, with data visualizations created in RStudio

Data Source and Inclusion/Exclusion Criteria:

Adults with relapsed/refractory multiple myeloma treated with ciltacel enrolled on CARTITUDE-1 

Inclusion and exclusion criteria 

All patients from the CARTITUDE-1 dataset with pre-treatment values for sBCMA available. Patients with missing data may be also utilized for comparison and/or modelling or imputing data as deemed necessary. 

"
  ["project_main_outcome_measure"]=>
  string(260) "Primary: Validation of pre-treatment sBCMA levels as a prognostic factor for PFS

Secondary: sBCMA impact on overall response rates (ORR), rates of MRD negativity, OS, incidence and grade of toxicity (CRS, ICANS and cytopenias).  





"
  ["project_main_predictor_indep"]=>
  string(63) "Pre-treatment (prior to lymphodepletion) sBCMA levels. 

"
  ["project_other_variables_interest"]=>
  string(667) "Covariates including age, performance status (ECOG), number of prior treatment lines, refractory status to lenalidomide, presence of extramedullary disease (EMD), bridging therapy requirement and response, renal function, cytogenetic risk, pre-treatment plasma cell marrow burden and baseline ferritin for comprehensive analysis. Outcomes measures as stated: PFS, OS, ORR, MRD negativity rates. Key dates such as date of diagnosis, date of CART infusion, date of progression/death or date of last follow up will also be required. Other sBCMA levels (at apheresis and at available timepoints post therapy would also serve as useful determinants of risk and response). "
  ["project_stat_analysis_plan"]=>
  string(1321) "All variables will be summarized with descriptive statistics. Mann-Whitney U test, ordinary least squares regression (OLS), chi-squared or Fisher’s exact used where appropriate. Ordinal logistical regression used to estimate the effect of sBCMA on CRS and ICANS severity and odds ratios (OR) were reported. Progression free survival (PFS) defined as time from date of CAR-T infusion to disease progression, relapse, or death from any cause. Overall survival (OS) calculated from the date of CAR-T cell infusion until death or last follow up. The Kaplan-Meier survival analysis were used to estimate differences for progression free survival (PFS) and overall survival (OS), statistical significance using the log-rank test for comparisons between groups[6-8]. Cox proportional hazards regression models were used to estimate the hazard ratios (HRs) for potential prognostic factors influencing PFS and OS [8] and likelihood ratio test (LRT) p-values reported. In multivariate models, previously established clinically important univariate factors [9] included, and the model’s performance reported. The optimal cut points for dichotomizing sBCMA and MTV will be determined per Liu et al., to maximize sensitivity and specificity [10]. R scripts used for linear regressions, logistical regressions, survival analyses. "
  ["project_timeline"]=>
  string(137) "Project Timeline:

Project Start: June 2024

Analysis Complete: August 2024

Manuscript Submission: March 2025 

"
  ["project_dissemination_plan"]=>
  string(1095) "Our findings on soluble B-cell maturation antigen (sBCMA) as a predictive biomarker for CAR T-cell therapy outcomes in multiple myeloma (MM) will be disseminated through:

Peer-Reviewed Manuscripts targeting high-impact journals in hematology and oncology, such as Blood and The Lancet Oncology.

Conference Presentations at key meetings including the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO), facilitating discussions with field experts.

Public Health Communications through accessible summaries and webinars for healthcare policymakers and patient advocacy groups, highlighting the study's relevance to MM treatment and care.

Audiences: Aimed at academic researchers, clinicians, healthcare policymakers, and patient communities, our goal is to advance scientific knowledge, influence clinical practice, and empower informed patient care decisions in MM.

This multi-faceted approach ensures broad and impactful dissemination, encouraging the integration of sBCMA in optimizing CAR T-cell therapy for MM.

"
  ["project_bibliography"]=>
  string(2025) "
 

Munshi, N.C., et al., Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. New England Journal of Medicine, 2021. 384(8): p. 705-716.
Raje, N., et al., Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine, 2019. 380(18): p. 1726-1737.
Berdeja, J.G., et al., Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. The Lancet, 2021. 398(10297): p. 314-324.
Michael, G., et al., Serum B-cell maturation antigen: a novel biomarker to predict outcomes for multiple myeloma patients. Haematologica, 2017. 102(4): p. 785-795.
Sanchez, E., et al., Serum B-cell maturation antigen is elevated in multiple myeloma and correlates with disease status and survival. Br J Haematol, 2012. 158(6): p. 727-38.
Kaplan, E.L. and P. Meier, Nonparametric Estimation from Incomplete Observations. Journal of the American Statistical Association, 1958. 53(282): p. 457-481.
Mantel, N., Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep, 1966. 50(3): p. 163-70.
Cox, D.R., Regression Models and Life-Tables. Journal of the Royal Statistical Society. Series B (Methodological), 1972. 34(2): p. 187-220.
Hansen, D.K., et al., Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma: Real-World Experience From the Myeloma CAR T Consortium. J Clin Oncol, 2023. 41(11): p. 2087-2097.
Liu, X., Classification accuracy and cut point selection. Stat Med, 2012. 31(23): p. 2676-86.

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    string(34) "yoda-project-review-2024-0388_site"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(14440)
    ["date"]=>
    string(19) "2024-11-05 19:02:11"
    ["modified"]=>
    string(19) "2024-11-05 19:02:11"
    ["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(15) "johnson-johnson"
  ["human_research_protection_training"]=>
  bool(false)
  ["request_overridden_res"]=>
  string(1) "3"
}
data partner
array(1) {
  [0]=>
  string(15) "johnson-johnson"
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(1) {
  [0]=>
  string(8) "carvykti"
}


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


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