Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- overall response rate (ORR) of teclistamab according to IMWG criteria
- timeFrame
- 6 months
- description
- ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.
- measure
- overall response rate (ORR) of teclistamab according to IMWG criteria
- timeFrame
- 24 months
- description
- ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.
Secondary outcomes (10)
- measure
- Effectiveness of teclistamab
- timeFrame
- 24 months
- description
- Progression Free Survival 1 and 2 (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available