A Real-World Study of Bispecific Antibodies in Multiple M... | NCT06359067

Studies
A Real-World Study of Bispecific Antibodies in Multiple Myeloma

NCT06359067

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Apr 11, 2024Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Treated by bispecific antibodies, teclistamab or elranatamab in usual care
Not treated by bispecific antibodies in usual care

Countries

France

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 2024

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

Jul 1, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Mar 25, 2024

First Submission Date that Met QC Criteria

Apr 8, 2024

First Posted Date

Apr 11, 2024Actual

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

Apr 8, 2024

Last Update Posted Date

Apr 11, 2024Actual

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

Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).

Detailed Description

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

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treated by bispecific antibodies		Patients with multiple myeloma, penta-drug or triple class refractory and treated by bispecific antibodies, teclistamab or elranatamab	Other: Treated by bispecific antibodies, teclistamab or elranatamab in usual care
Control group		Patients with multiple myeloma, penta-drug or triple class refractory and not treated by bispecific antibodies	Other: Not treated by bispecific antibodies in usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treated by bispecific antibodies, teclistamab or elranatamab in usual care	Other	Treated by bispecific antibodies, teclistamab or elranatamab in usual care	Treated by bispecific antibodies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infection rate	Explore the infection rate	Up to 18 months

Secondary Outcomes

Measure	Description	Time Frame
Global survival	Explore the global survival	Up to 18 months
Progression-free survivals	Explore the progression-free survivals	Up to 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult ≥ 18 years old
Patients with multiple myeloma
Patients who received at least one administration of the following therapies: teclistamab, elranatamab

Exclusion Criteria:

- Patients opposed to the collection of their personal data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with multiple myeloma treated with bispecific antibodies, teclistamab or elranatamab.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeremie ZERBIT, PharmD	Pharmacy Department, Assistance Publique-Hopitaux de Paris, Université de Paris, Paris, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique - Hôpitaux de Paris (AP-HP)		Paris	IDF	75004	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided