NCT07564128

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started Aug 2026

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

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Multiple Mieloma

Keywords

Relapsed/Refractory Multiple MyelomaInfection SurveillanceElranatamab

Outcome Measures

Primary Outcomes (1)

  • Infection rate in the first 12 months of therapy with elranatamab

    12 months

Study Arms (1)

Adult patients with R/R Multiple Myeloma treated with elranatamab as standard clinical practice

Eligibility Criteria

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

Adult patients with Relapsed/Refractory Multiple Myeloma treated with elranatamab as standard clinical practice

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Paola Fazi

CONTACT

0039 0670390528p.fazi@gimema.it

Enrico Crea

CONTACT

0039 0670390514e.crea@gimema.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share