Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients

Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients: a Collaborative Janssen - IFM Study IFM 2023-01: TEC-CARE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06062537

Acronym

TEC-CARE

Enrollment

200

Registered

2023-10-02

Start date

2023-09-19

Completion date

2026-12-01

Last updated

2026-04-13

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

Conditions

Multiple Myeloma

Keywords

teclistamab, refractory multiple myeloma, real word evidence study

Brief summary

200 adult patients with multiple myeloma receiving teclistamb will be included. Effectiveness, safety, and condition of use of teclistamab in early access program (post-MA) will be assessed. Primary objective is the evaluation of overall response rate (ORR) of teclistamab according to IMWG criteria. This is a multicenter, prospective, observational study.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)

Exclusion criteria

* Patients alive at the start of the study who did not receive study information or who objected to the collection of data * Patients who received teclistamab as part of an interventional clinical trial * Patients who are initiating teclistamab as part of a current interventional clinical trial

Design outcomes

Primary

Measure	Time frame	Description
overall response rate (ORR) of teclistamab according to IMWG criteria	6 months	ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.

Secondary

Measure	Time frame	Description
Effectiveness of teclistamab	24 months	Progression Free Survival 1 and 2 (PFS)
Adverse events of interest	24 months	ICANS, CSR and infections
Conditions of use	1 month	Patients' profiles (demographics characteristics and medical history) \- Injection facilities and schedules during step-up dosing phase

Countries

France

Outcome results