TriangleNCT02874742 · MORE INFO
Limitations, agreements, and source contact
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- certain Agreement
- other Details
- If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- Initial protocol did not require minimal residual disease (MRD) testing in all participants, impacting the interpretation of MRD negativity rates in intent-to-treat (ITT) group, which strongly favored daratumumab treatment. Sensitivity analysis, including MRD negativity rate in participants with a complete response (CR) or better and with an informative baseline clone and follow-up MRD testing, were performed and confirmed a strong benefit for daratumumab treatment.
- point Of Contact
- ClinicalTrialDisclosure@its.jnj.com
- organization
- Janssen Research & Development, LLC
- phone
- 844-434-4210
- title
- Clinical Leader
Complete source fields
- certain Agreement
- other Details
- If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- Initial protocol did not require minimal residual disease (MRD) testing in all participants, impacting the interpretation of MRD negativity rates in intent-to-treat (ITT) group, which strongly favored daratumumab treatment. Sensitivity analysis, including MRD negativity rate in participants with a complete response (CR) or better and with an informative baseline clone and follow-up MRD testing, were performed and confirmed a strong benefit for daratumumab treatment.
- point Of Contact
- ClinicalTrialDisclosure@its.jnj.com
- organization
- Janssen Research & Development, LLC
- phone
- 844-434-4210
- title
- Clinical Leader
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice