NCT06285318 A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials
| NCT ID | NCT06285318 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janssen-Cilag Ltd. |
| Condition | Relapsed/Refractory Multiple Myeloma (RRMM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2023-12-18 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.
Eligibility Criteria
Inclusion Criteria: * Have a documented diagnosis of multiple myeloma * Received the first dose of teclistamab on or before 31 December 2022, regardless of the duration of teclistamab treatment (REALiTEC cohort 1) OR Received the first dose of teclistamab from 01 January 2023 to 31 December 2024, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 2) OR Received the first dose of teclistamab from 01 January 2025 to 31 December 2025, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 3) OR Received the first dose of talquetamab on or before 31 December 2023, regardless of the duration of talquetamab treatment (REALiTAL cohort). Participants who received both teclistamab \& talquetamab can be included in both REALiTEC and REALiTAL cohorts * Received at least one dose of teclistamab/talquetamab * Provision of a patient-signed informed consent form (ICF), or an ICF waiver for deceased patients as applicable based on country/site-specific requirements Exclusion Criteria: * To be excluded from REALiTEC cohorts if received teclistamab as part of an interventional clinical trial * To be excluded from REALiTAL cohort if received talquetamab as part of an interventional clinical trial * Participants who have received teclistamab as part of a Janssen pre-approval access program are excluded from the REALiTEC Cohort 2 and REALiTEC Cohort 3
Contact & Investigator
Janssen-Cilag Limited Clinical Trial
STUDY DIRECTOR
Janssen-Cilag Limited
Frequently Asked Questions
Who can join the NCT06285318 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed/Refractory Multiple Myeloma (RRMM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06285318 currently recruiting?
Yes, NCT06285318 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT06285318 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus N, Denmark, Copenhagen, Denmark, Odense, Denmark and 11 additional locations.
Who is sponsoring the NCT06285318 clinical trial?
NCT06285318 is sponsored by Janssen-Cilag Ltd.. The principal investigator is Janssen-Cilag Limited Clinical Trial at Janssen-Cilag Limited. The trial plans to enroll 900 participants.