Evidence map›Paper›PMID 40613875›Full record

Trial reportAdvances in therapy2025

Survival Outcomes with Cilta-cel Versus Conventional Treatment Regimens for Patients with Lenalidomide-Refractory Multiple Myeloma Using Inverse Probability of Treatment Weighting.

Rafael Fonseca, Joris Diels, Francesca Ghilotti, João Mendes, Sandra Van Hoorenbeeck, Seina Lee, Jordan M Schecter, Nikoletta Lendvai, Nitin Patel, Ana Triguero and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04181827 (A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04181827 phase3active not recruitingnot on this map

A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2020 to 2027Enrolled419ConditionsMultiple MyelomaArmsCilta-cel, Pomalidomide, Bortezomib, Dexamethasone, Daratumumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Rafael FonsecaMayo Clinic, 5700 E Mayo Blvd, Phoenix, AZ, 85054, USA. fonseca.rafael@mayo.edu.
Joris DielsJohnson & Johnson, Beerse, Belgium.
Francesca GhilottiJohnson & Johnson, Milan, Italy.
João MendesJohnson & Johnson, Raritan, NJ, USA.
Sandra Van HoorenbeeckJohnson & Johnson, Beerse, Belgium.
Seina LeeJohnson & Johnson, Raritan, NJ, USA.
Jordan M SchecterJohnson & Johnson, Raritan, NJ, USA.
Nikoletta LendvaiJohnson & Johnson, Raritan, NJ, USA.
Nitin PatelLegend Biotech USA Inc., Somerset, NJ, USA.
Ana TrigueroHosp. Clinic I Provincial de Barcelona, Barcelona, Spain.
Winfried AlsdorfUniversity Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Niels W C J van de DonkAmsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Margherita UrsiOspedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna, Bologna, Italy.

Funding

Project 4: Targeting Resistance to T-Cell Directed Therapy in Multiple MyelomaP50CA186781 · NCI · MAYO CLINIC ARIZONA · PI Yi Lin · 2015 to 2026
$25.5M
Mayo Clinic Center for Clinical ProteomicsU01CA271410 · NCI · MAYO CLINIC ROCHESTER · PI Rafael Fonseca, AKHILESH PANDEY · 2022 to 2026
$5.3M
NCI NIH HHS NCI U01CA271410NCI NIH HHS P50 CA186781NCI NIH HHS U01 CA271410
6 · The paper itself

Abstract

introductionThe phase 3 CARTITUDE-4 trial demonstrated superiority of ciltacabtagene autoleucel (cilta-cel) over daratumumab, pomalidomide and dexamethasone, or pomalidomide, bortezomib and dexamethasone, in lenalidomide-refractory patients with relapsed/refractory multiple myeloma (RRMM) who received 1-3 prior lines of therapy. The comparative efficacy of cilta-cel was previously evaluated against other common regimens. Here, we present an updated comparative efficacy assessment, including OS, between cilta-cel (CARTITUDE-4 34-month median follow-up) and common regimens.

methodsIndividual patient data were available from CARTITUDE-4 (cilta-cel), CASTOR (daratumumab, bortezomib and dexamethasone [DVd]), CANDOR (daratumumab, carfilzomib and dexamethasone [DKd] and carfilzomib and dexamethasone [Kd]) and APOLLO (pomalidomide and dexamethasone [Pd]). Inverse probability of treatment weighting (IPTW) was used to adjust for key baseline patient characteristic imbalances. Relative efficacies were estimated with response rate ratios and 95% confidence intervals (CIs) for response rates, with hazard ratios (HRs) and 95% CIs for PFS and OS. Sensitivity analyses using alternative statistical approaches were explored.

resultsAfter excluding 53 patients with prior anti-CD38 therapy exposure, cilta-cel (n = 155) was compared with DVd (n = 44), DKd (n = 98), Kd (n = 46) and Pd (n = 92). Baseline covariates were generally well balanced across cohorts after IPTW. Cilta-cel showed significant improvements in PFS (HR 0.21-0.58; p ≤ 0.01) and OS (HR 0.31-0.55; p < 0.05) vs all regimens. With longer follow-up, the relative benefit of cilta-cel versus other regimens further increased on deeper levels of response. Although all results, except ORR, significantly favored cilta-cel, the DKd comparison provided the most conservative estimates.

conclusionThis updated analysis confirms previously observed significant superiority of PFS and response outcomes of cilta-cel while showing significant OS benefit compared with common regimens for this population. These findings support cilta-cel as an effective treatment for lenalidomide-refractory RRMM patients as early as second line.

trial registrationCARTITUDE-4 ClinicalTrials.gov ID: NCT04181827.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsMultiple MyelomaAgedAged, 80 and overAntibodies, MonoclonalBortezomibDexamethasoneDrug Resistance, NeoplasmFemaleHumansLenalidomideMaleMiddle AgedOligopeptidesThalidomideTreatment OutcomeAntibodies, MonoclonalBortezomibcarfilzomibdaratumumabDexamethasoneLenalidomideOligopeptidespomalidomideThalidomideCARTITUDE-4Ciltacabtagene autoleucelIndirect comparisonInverse probability of treatment weightingLenalidomide refractoryRelapsed or refractory multiple myeloma

Identifiers

PMID40613875
PMCPMC12394250

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.