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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07564128

Acronym

RISE

Enrollment

Registered

2026-05-04

Start date

2026-08-01

Completion date

2028-02-01

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Mieloma

Keywords

Relapsed/Refractory Multiple Myeloma, Infection Surveillance, Elranatamab

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Infection rate in the first 12 months of therapy with elranatamab	12 months

Contacts

CONTACTPaola Fazi

p.fazi@gimema.it0039 0670390528

CONTACTEnrico Crea

e.crea@gimema.it0039 0670390514

Outcome results