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Not yet recruiting NCT07564128

Infection Surveillance of R/R Multiple Myeloma Patients Treated With Elranatamab as Clinical Practice in Italy

Observational Multiple Mieloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Mieloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

An Italian Registry for Infection Surveillance of Patients Undergoing Salvage Treatment With Elranatamab Monotherapy

Overview

The primary objective of this study is to measure the infection rate and presentation pattern in first 12 months of therapy with elranatamab as standard clinical practice in adult patients with Relapsed/Refractory Multiple Myeloma.

Primary outcome measures

  • Infection rate in the first 12 months of therapy with elranatamab [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • adult patients (age >18 years) with no upper age limit
  • confirmed Relapsed and Refractory Multiple Myeloma (RRMM) according to IMWG criteria (demonstrated disease progression on the last therapy (progressed on or within 60 days of last therapy).
  • Patients must have received at least three (3) prior lines of therapy, including at least: one Immunomodulatory agent (e.g., Lenalidomide, Pomalidomide), one Proteasome Inhibitor (e.g., Bortezomib, Carfilzomib), one Anti-CD38 Monoclonal Antibody (e.g., Daratumumab, Isatuximab).
  • Treatment with elranatamab within standard clinical practice
  • Written informed consent signature

Exclusion criteria

none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07564128 · MM0426

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗