Trial reportThe Lancet. Haematology2025
Patient-reported outcomes following ciltacabtagene autoleucel or standard of care in patients with lenalidomide-refractory multiple myeloma (CARTITUDE-4): results from a randomised, open-label, phase 3 trial.
Trial report in The Lancet. Haematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- CAR-T therapy is the preferred option in relapsed/refractory multiple myeloma.Blood advances · 2026Article
- CRISPR application in hematological disorders: from bench to bedside.Blood advances · 2026Review
- Health-related quality of life reporting in randomized controlled trials of chimeric antigen receptor T-cell therapy: A systematic review of dedicated publications.British journal of haematology · 2026Article
- Patient-reported outcomes after idecabtagene vicleucel vs. ciltacabtagene autoleucel CAR-T for multiple myeloma.Bone marrow transplantation · 2026Article
- Review
- Optimizing ciltacabtagene autoleucel outcomes: real-world experience and best practices from a single academic center.Frontiers in oncology · 2026Article
- Beyond exhaustion: T cell fitness for next generation of immunotherapy for hematological cancer.Frontiers in immunology · 2026Review
- From toxicity to immunity: Evaluating CAR-T and conventional therapies in multiple myeloma through quality-adjusted life year (QALY) outcomes.Therapeutic advances in hematology · 2026Review
- Patient-reported outcomes in patients with hematologic malignancies treated with CAR T-cell therapy in Europe.Blood advances · 2025Article
- CAR T-cell therapy and bispecific antibodies in the management of multiple myeloma.Hematology. American Society of Hematology. Education Program · 2025Review
- Current Status of Molecularly Targeted Therapeutics in Blood Cancers.International journal of molecular sciences · 2025Review
- Advances in Nanobody-Based Platforms for Precision Cancer Diagnosis and Therapy.Polymer science & technology (Washington, D.C.) · 2025Review
- Assessing Quality of Life and Symptoms in Transplantation and CAR-T Recipients: Expert Panel Recommendations from the Survivorship Special Interest Group of ASTCT.Transplantation and cellular therapy · 2025Review
- Clinical benefit loss in myeloma patients declining autologous stem cell transplantation: a real-world study.Discover oncology · 2025Article
- Establishing a successful outpatient CAR T-Cell program with cilta-cel: real-world experience from an expert roundtable.Future oncology (London, England) · 2025Review
Corrections and comments
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Authors and funding
25 authors.
Funding
Abstract
backgroundIn CARTITUDE-4, ciltacabtagene autoleucel (cilta-cel) significantly improved progression-free survival (primary endpoint; previously reported) versus standard of care in patients with relapsed, lenalidomide-refractory multiple myeloma. We report here patient-reported outcomes.
methodsIn the ongoing, phase 3, open-label CARTITUDE-4 study, patients were recruited from 81 sites in the USA, Europe, Asia, and Australia, and were randomly assigned 1:1 to cilta-cel (target, 0·75 × 10
findingsPatients were enrolled from July 10, 2020, to Nov 17, 2021, and 419 of 516 screened patients were randomly assigned (cilta-cel, n=208; standard of care, n=211; median follow-up, 15·9 months [IQR 12·4 to 17·8]); median age was 61 years. 191 (92%) of 208 patients in the cilta-cel group and 190 (91%) of 209 evaluable patients in the standard- of-care group completed baseline assessments. MySIm-Q compliance post-baseline was 70 to 81% (cilta-cel) and 79 to 89% (standard of care). MySIm-Q median time to sustained symptom worsening with cilta-cel versus standard of care was 23·7 versus 18·9 months (HR 0·42; 95% CI 0·26 to 0·68). 12-month mean changes for EORTC global health status (GHS) were +10·1 (95% CI 7·0 to 13·1) and -1·5 (95% CI -5·3 to 2·3) points and were +8·0 (95% CI 5·2 to 10·7) and +1·4 (95% CI -1·9 to 4·7) points for EQ-5D-5L visual analogue scale (VAS). Rates of clinically meaningful improvements in GHS and VAS were higher with cilta-cel than with standard of care.
interpretationHealth-related QoL improvements and delayed symptom worsening support cilta-cel's clinical efficacy in lenalidomide-refractory disease.
fundingJanssen Research & Development, Legend Biotech USA.
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