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Retrospective Cohort Study
Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Exp Med. Sep 20, 2026; 16(3): 125753
Published online Sep 20, 2026. doi: 10.5493/wjem.125753
Real-world outcomes for multiple myeloma patients after apheresis for planned chimeric antigen receptor T-cell therapy
Ayrton Bangolo, Sarvarinder Gill, Lili Zhang, Jiahe Zhao, Behzad Amoozgar, Ronit Reich-Slotky, Justin Tran, Tri Vo, Gabby Mariblanca, Xenia Balulescu, Sean Mcknight, Nidhi Patel, Aidan Reed, Sukhmani Kaur, Shalini Subramanian, Julie Katyal, Christo Manikkuttiyil, Morgan Chakov, Alisa Nguyen, Sanjana Pashine, Andre Khalil, Steven Mathew, Ravdeep Gill, Varun Andrews, Philip Ordonez, Benjamin Olson, Marianne Koleng, Rajin Persaud, Hrithik S Saride, Mikhail Dharsi, Romon Thach, Winnie Chen, Mahad Shahid, Simcha Weissman, David Siegel, Harsh Parmar, Noa Biran, David H Vesole, Pooja Phull
Ayrton Bangolo, Department of Hematology and Oncology, John Theurer Cancer Center, Hackensack, NJ 07601, United States
Sarvarinder Gill, Division of Leukemia, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ 07601, United States
Lili Zhang, Jiahe Zhao, Behzad Amoozgar, Department of Hematology and Oncology, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ 07601, United States
Ronit Reich-Slotky, David Siegel, Harsh Parmar, Noa Biran, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ 07601, United States
Justin Tran, Tri Vo, Gabby Mariblanca, Xenia Balulescu, Sean Mcknight, Nidhi Patel, Aidan Reed, Sukhmani Kaur, Shalini Subramanian, Julie Katyal, Christo Manikkuttiyil, Morgan Chakov, Alisa Nguyen, Sanjana Pashine, Andre Khalil, Steven Mathew, Ravdeep Gill, Varun Andrews, Philip Ordonez, Benjamin Olson, Marianne Koleng, Rajin Persaud, Hrithik S Saride, Mikhail Dharsi, Romon Thach, Winnie Chen, Mahad Shahid, Internal Medicine, Palisades Medical Center, North Bergen, NJ 07047, United States
Simcha Weissman, Internal Medicine, Hackensack Meridian Health Palisades Medical Center, North Bergen, NJ 07047, United States
David H Vesole, Pooja Phull, John Theurer Cancer Center, Hackensack Meridian School of Medicine, Hackensack, NJ 07601, United States
Author contributions: Bangolo A and Gill S contributed to the methodology, data curation, formal analysis, investigation, writing-original draft and visualization; Tran J, Vo T, Mariblanca G, Balulescu X, Mcknight S, Patel N, Reed A, Kaur S, Subramanian S, Katyal J, Manikkuttiyil C, Chakov M, Nguyen A, Pashine S, Khalil A, Mathew S, Gill R, Andrews V, Ordonez P, Olson B, Koleng M, Persaud R, Saride HS, Dharsi M, Thach R, Chen W, Shahid M, and Weissman S performed data curation; Reich-Slotky R and Parmar N carried out formal analysis; Amoozgar B contributed to writing-original draft; Siegel D, Biran N, and Vesole DH provided supervision; Siegel D and Vesole DH contributed to resources; Phull P contributed to the methodology, supervision, project administration and resources; and all authors performed investigation, reviewed and edited the manuscript.
AI contribution statement: The authors utilized an artificial intelligence-based language model to assist in the preparation of this manuscript. The primary role of the AI was to perform grammar and spelling correction. Additionally, it was used to improve sentence structure for clarity and readability. All suggestions and modifications proposed by the AI were reviewed and critically edited by the human authors, who retain full responsibility for the final content and scientific integrity of this work.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Hackensack Meridian Health, approval No. Pro2024-0214.
Informed consent statement: Patient consent was waived as this project represented a non-interventional study utilizing routinely collected data for secondary research purposes.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Data sharing statement: The complete datasets used and/or analyzed during this study are available from the corresponding author upon request. Requests can be made through the corresponding author or directly to representatives of Hackensack Meridian Health (Ayrton Bangolo; Email: Ayrton.bangolo@hmhn.org).
Corresponding author: Ayrton Bangolo, Chief Physician, Department of Hematology and Oncology, John Theurer Cancer Center, 92 2nd Street, Hackensack, NJ 07601, United States. ayrton.bangolo@hmhn.org
Received: July 16, 2026
Revised: August 12, 2026
Accepted: September 16, 2026
Published online: September 20, 2026
Processing time: 67 Days and 0.6 Hours
Abstract
BACKGROUND

Chimeric antigen receptor T-cell (CAR-T) therapy is highly active in relapsed/refractory multiple myeloma (RRMM), but manufacturing creates an obligatory waiting period between apheresis and infusion. Patients may deteriorate, progress or die during this window. Analyses that begin follow-up at infusion exclude these patients entirely and cannot describe the experience of all patients who enter the CAR-T pathway.

AIM

To describe, in an intention-to-collect fashion, the outcomes of all RRMM patients who underwent T-cell apheresis for planned CAR-T therapy; to characterise the apheresis-to-infusion interval and the reasons for, and correlates of, failure to reach infusion; and to report progression-free survival (PFS) and overall survival (OS) anchored at the date of apheresis. The study was descriptive; it was not designed to estimate the causal effect of CAR-T infusion on survival.

METHODS

Retrospective single-centre cohort of all RRMM patients undergoing T-cell apheresis for CAR-T at Hackensack University Medical Center between 1 January 2021 and 30 April 2024. PFS and OS were calculated from apheresis by the Kaplan-Meier method with Greenwood 95% confidence intervals (CIs) and numbers at risk. Groups were compared with the log-rank test; baseline characteristics with the Wilcoxon rank-sum and Fisher exact tests. Because infusion is a post-baseline, time-dependent event, the association between infusion and survival was additionally examined using a Mantel-Byar time-dependent Cox model and a 60-day landmark analysis. Correlates of non-infusion were examined by univariable logistic regression; multivariable modelling was not performed owing to the small number of events.

RESULTS

Of 99 patients undergoing apheresis, 87 (87.9%, 95%CI: 79.8-93.6) were infused and 12 (12.1%, 95%CI: 6.4-20.2) were not. Median follow-up was 14.0 months [interquartile range (IQR): 8.2-20.7]. Median apheresis-to-infusion interval was 54 days (IQR 46-62; range 37-202; n = 84 evaluable). Contrary to our preliminary report, baseline disease phenotype differed significantly between groups: Extramedullary disease was present in 9/12 (75.0%) non-infused vs 17/87 (19.5%) infused patients (P < 0.001), and plasma cell leukaemia in 3/12 (25.0%) vs 3/87 (3.4%) (P = 0.017). Age, prior lines of therapy (median 5 in both), high-risk cytogenetics (36.4% vs 34.1%) and Revised International Staging System distribution did not differ. The commonest reasons for non-infusion were progressive disease or myeloma-related death (7/12, 58.3%), non-myeloma death (2/12, 16.7%), manufacturing or collection failure (2/12, 16.7%) and infection (1/12, 8.3%). The median time from apheresis to the attrition event was 44 days (IQR 30-72). Median PFS from apheresis was 17.5 months (95%CI: 12.7-21.6) in infused patients vs 1.5 months (95%CI: 0.8-2.3) in non-infused patients; median OS was not reached vs 1.9 months (95%CI: 1.0-6.2) (both log-rank P < 0.001). In the time-dependent Cox model the hazard ratio for death associated with infusion was 0.24 (95%CI: 0.11-0.53), substantially closer to the null than the unadjusted comparison, illustrating how much of the apparent difference reflects the time-dependent nature of the exposure and confounding by disease phenotype.

CONCLUSION

In this descriptive cohort, roughly one in eight patients who underwent apheresis never received CAR-T, and attrition clustered before the median time to infusion and among patients with extramedullary disease or plasma cell leukaemia. These data support shortening manufacturing turnaround, prioritising patients with aggressive phenotypes for expedited slots and intensified bridging, and reporting outcomes from apheresis using analytic methods that respect the time-dependent nature of infusion.

Keywords: Multiple myeloma; Chimeric antigen receptor T-cell therapy; Apheresis; Real-world data; Bridging therapy; Attrition; Immortal-time bias; Time-dependent analysis; B-cell maturation antigen

Core Tip: Among 99 myeloma patients undergoing apheresis for planned chimeric antigen receptor T-cell therapy, 12% progressed or died before manufacturing completed (median 54 days). This attrition disproportionately affected patients with aggressive phenotypes, such as extramedullary disease or plasma cell leukaemia. Because raw survival differences overstate treatment effects due to survival bias during manufacturing, time-dependent analyses are essential. Clinically, these findings highlight the urgent need for shorter manufacturing times, intensified bridging therapy and expedited scheduling for high-risk patients, and standardizing outcome reporting from the date of apheresis.

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