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NCT03117361 · MORE INFO

Limitations, agreements, and source contact

Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide · Source last updated 2020-12-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

certain Agreement
other Details
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
pi Sponsor Employee
false
restriction Type
OTHER
restrictive Agreement
true
limitations And Caveats
description
On 29052018 the Sponsor closed the recruitment of the study due to the slow patient accrual. Besides the negative opinion of the EMA recommending the refusal of the marketing authorization for plitidepsin for MM reinforced the decision.
point Of Contact
email
clinicaltrials@pharmamar.com
organization
Pharma Mar, S.A.
phone
+34 918466000
title
Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
Complete source fields
certain Agreement
other Details
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
pi Sponsor Employee
false
restriction Type
OTHER
restrictive Agreement
true
limitations And Caveats
description
On 29052018 the Sponsor closed the recruitment of the study due to the slow patient accrual. Besides the negative opinion of the EMA recommending the refusal of the marketing authorization for plitidepsin for MM reinforced the decision.
point Of Contact
email
clinicaltrials@pharmamar.com
organization
Pharma Mar, S.A.
phone
+34 918466000
title
Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice