Respiatory Viral Infections in Patients With Multiple Mye... | NCT06810115

Studies
Respiatory Viral Infections in Patients With Multiple Myeloma

NCT06810115

Sponsor

University Medical Centre Ljubljana

Status

Completed

Last Update Posted

Feb 5, 2025Actual

Enrollment

219Actual

Phase

Not provided

Conditions

Multiple Mieloma
Respiratory Viral Infections

Interventions

Viral PCR test

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

Oct 1, 2024Actual

First Submitted Date

Jan 30, 2025

First Submission Date that Met QC Criteria

Jan 30, 2025

First Posted Date

Feb 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2025

Last Update Posted Date

Feb 5, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Polona Novak, Polona Novak, MD, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Respiratory viruses are known to be a major cause of morbodity in multiple myeloma patients but prospective long-term sudies are lacking. We analysed 219 multiple myeloma patients that had 554 nasopharingeal swabs with 58 documented viral episodes. Respiratory viruses studied were rhinovirus, enterovirus, parainflienza, respirator, syncytial virus, metapneumovirus, coronavirus, bocavirus, influenza A, influenza B. Clinical data were extracted from a prospectively entered database, medical records were reviewed. We have prospectively studiend patients until May 2019 when we gathered survival data. Lastly because of Covid-19 pandemic when almost no other viral infections were isolated, we analysed clinical course of respiratory infections in patients with multiple myeloma after the pandemic.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

219Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with multiple myeloma			Other: Viral PCR test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Viral PCR test	Other	Viral PCR test regardles of symptoms	Patient with multiple myeloma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of respiratory viral infections in patirnts with multiple myeloma		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with multiple myeloma

Exclusion Criteria:Other hematological malignancies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient with multiple myeloma on observation/receiving treatment at outpatient clinuc

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25344526	Result	Blimark C, Holmberg E, Mellqvist UH, Landgren O, Bjorkholm M, Hultcrantz M, Kjellander C, Turesson I, Kristinsson SY. Multiple myeloma and infections: a population-based study on 9253 multiple myeloma patients. Haematologica. 2015 Jan;100(1):107-13. doi: 10.3324/haematol.2014.107714. Epub 2014 Oct 24.