TriangleNCT02685826 · 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
- Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- The study was placed on full clinical hold by the United States (US) Food and Drug Administration (FDA) on 05 Sep 2017. As the result, the study was closed for further enrollment, and all participants were discontinued from all study treatments (durvalumab, lenalidomide and dexamethasone). All participants were followed for second primary malignancies (SPMs), every 6 months for 5 years after the last participant has been enrolled as per protocol.
- point Of Contact
- Clinical.Trials@bms.com
- organization
- Bristol-Myers Squibb
- phone
- Please Email
- title
- Bristol-Myers Squibb Study Director
Complete source fields
- certain Agreement
- other Details
- Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- The study was placed on full clinical hold by the United States (US) Food and Drug Administration (FDA) on 05 Sep 2017. As the result, the study was closed for further enrollment, and all participants were discontinued from all study treatments (durvalumab, lenalidomide and dexamethasone). All participants were followed for second primary malignancies (SPMs), every 6 months for 5 years after the last participant has been enrolled as per protocol.
- point Of Contact
- Clinical.Trials@bms.com
- organization
- Bristol-Myers Squibb
- phone
- Please Email
- title
- Bristol-Myers Squibb Study Director
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice