Evidence map›Paper›PMID 41036677›Full record

Trial reportCancer medicine2025

Characterization and Management of Cytokine Release Syndrome From the MonumenTAL-1 Study of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma.

Niels W C J van de Donk, Ajai Chari, Thomas Martin, Amrita Krishnan, Leo Rasche, Jing Christine Ye, Rakesh Popat, Brea Lipe, Cesar Rodriguez, Carolina Schinke and 13 more

2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT03399799 phase1active not recruitingnot on this map

64407564MMY1001: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2027Enrolled279ConditionsHematological MalignanciesArmsTalquetamab
NCT04634552 phase2recruitingnot on this map

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2021 to 2029Enrolled510ConditionsHematological MalignanciesArmsTalquetamab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. 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

23 authors.

Niels W C J van de DonkAmsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
Ajai ChariUniversity of California San Francisco, San Francisco, California, USA.
Thomas MartinUniversity of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA.
Amrita KrishnanCity of Hope Comprehensive Cancer Center, Duarte, California, USA.
Leo RascheUniversity Hospital of Würzburg, Würzburg, Germany.ORCID https://orcid.org/0000-0002-9536-9649
Jing Christine YeMD Anderson Cancer Center, University of Texas, Houston, Texas, USA.
Rakesh PopatUniversity College London Hospitals, NHS Foundation Trust, London, UK.
Brea LipeUniversity of Rochester Medical Center, Rochester, New York, USA.
Cesar RodriguezDepartment of Hematology and Oncology, School of Medicine, Wake Forest University, Winston-Salem, North Carolina, USA.
Carolina SchinkeMyeloma Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Sheri SkergetJohnson & Johnson, Spring House, Pennsylvania, USA.
Deeksha VishwamitraJohnson & Johnson, Spring House, Pennsylvania, USA.
Raluca VeronaJohnson & Johnson, Spring House, Pennsylvania, USA.
Jue GongJohnson & Johnson, Spring House, Pennsylvania, USA.
Indrajeet SinghJohnson & Johnson, Spring House, Pennsylvania, USA.
Michela CampagnaJohnson & Johnson, Madrid, Spain.
Tara MastersonJohnson & Johnson, Spring House, Pennsylvania, USA.
Brandi HilderJohnson & Johnson, Spring House, Pennsylvania, USA.
Jaszianne TolbertJohnson & Johnson, Spring House, Pennsylvania, USA.
Thomas RenaudJohnson & Johnson, Raritan, New Jersey, USA.
M Damiette SmitJohnson & Johnson, Leiden, the Netherlands.
Christoph HeuckJohnson & Johnson, Spring House, Pennsylvania, USA.
Maria-Victoria MateosUniversity Hospital of Salamanca/IBSAL/CIC/CIBERONC, Salamanca, Spain.ORCID https://orcid.org/0000-0003-2390-1218

Funding

Johnson & Johnson
6 · The paper itself

Abstract

introductionCytokine release syndrome (CRS) is a common adverse event associated with T-cell redirection therapies (TCRT), including talquetamab, the first GPRC5D × CD3 bispecific antibody approved for relapsed/refractory multiple myeloma (RRMM). We describe CRS with talquetamab and implications for clinical practice.

methodsPatients without prior TCRT received talquetamab 0.4 mg/kg weekly (QW) and 0.8 mg/kg every other week (Q2W), with two or three step-up doses, respectively, plus pretreatment with a glucocorticoid, antihistamine, and antipyretic. A separate cohort of patients with prior TCRT received talquetamab at either the QW or Q2W schedule. CRS was graded per American Society for Transplantation and Cellular Therapy criteria and managed per study protocol.

resultsAcross talquetamab QW (n = 143), Q2W (n = 145), and prior TCRT (n = 51) cohorts, most CRS events occurred during step-up doses and were grade 1 or 2; grade 3 CRS events were rare. Approximately one-third of patients experienced more than one CRS event. Fewer patients experienced subsequent CRS events if tocilizumab was used versus not used to treat their first CRS event. Overall response rates with talquetamab were similar among patients with and without tocilizumab to manage CRS. Baseline characteristics were not associated with CRS incidence, recurrence, duration, or severity, whereas immune biomarkers showed some trends in association with CRS parameters.

conclusionCRS outcomes with talquetamab were consistent with those seen with other TCRT in RRMM, including teclistamab (BCMA×CD3 bispecific antibody), indicating a similar clinical approach, including early vigilance and prompt treatment of CRS.

trial registrationNCT03399799/NCT04634552.

Indexed as

Antibodies, BispecificAntineoplastic Agents, ImmunologicalCytokine Release SyndromeMultiple MyelomaAdultAgedFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalAntibodies, BispecificAntineoplastic Agents, Immunologicaltalquetamabclinical managementcytokine release syndromeGPRC5Dinterleukin‐6talquetamabtocilizumab

Identifiers

PMID41036677
PMCPMC12489744

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.