NCT07713511

Brief Summary

This study includes adults with multiple myeloma or B-cell lymphoma who were/will be treated with CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The aim is to better understand infections that may occur during the first year after CAR-T treatment, including how often they happen, their causes, and factors that may increase the risk. The study will use information from patients treated in the past and from newly enrolled patients. For some patients who develop fever after CAR-T therapy, a rapid molecular blood test will be used alongside standard tests to help identify bloodstream infections more quickly and support timely clinical care.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Nov 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

June 19, 2026

Last Update Submit

July 17, 2026

Conditions

Relapsed Multiple MyelomaRefractory Multiple MyelomaB-Cell Non-Hodgkin LymphomaBloodstream InfectionsCAR-T Cell Therapy

Keywords

Multiple MyelomaB-cell Non-Hodgkin LymphomaCAR-T Cell TherapyCAR-T Cell InfusionBloodstream InfectionInfectious ComplicationsCAR-TddPCR blood testCytokine Release SyndromeCRS

Outcome Measures

Primary Outcomes (1)

  • Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.

    Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.

    Within 12 months after CAR-T infusion

Secondary Outcomes (5)

  • Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.

    Within 12 months after CAR-T infusion

  • Classification of the first febrile episode within 30 days after CAR-T infusion.

    Within the first 30 days after CAR-T infusion

  • Participants with microbiologically documented infection at the first febrile episode.

    Within the first 30 days after CAR-T infusion.

  • Post-Discharge Infectious Complications.

    From hospital discharge up to 12 months after CAR-T infusion.

  • Diagnostic Yield of the Pilot Gene ddPCR Blood Test.

    Up to 12 months after enrollment (at the first febrile episode)

Study Arms (1)

Adult patients (≥18 years old) undergoing CAR-T cell therapy at IRCCS AOUBo

Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods

You may qualify if:

  • Diagnosis of relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL)
  • Receipt of CAR-T infusion at IRCCS AOUBo
  • Age ≥18 years at the time of CAR-T infusion
  • Signed informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138, Italy

Location

MeSH Terms

Conditions

Multiple MyelomaLymphoma, B-CellSepsisCytokine Release Syndrome

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphomaLymphatic DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Zeno Adrien Igor Pasquini

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeno Adrien Igor Pasquini, MD

CONTACT

+39 051 214 3752zeno.pasquini@aosp.bo.it

Maddalena Giannella, MD, PhD

CONTACT

+39 051 2143199maddalena.giannella@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2026

First Posted

July 20, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

April 30, 2029

Last Updated

July 20, 2026

Record last verified: 2026-07

Locations

IT(1)