Participant flow

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.

groups

1. description

   Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.

   id

   FG000

   title

   Experimental

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Progressive disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      On study treatment at the end of study

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Treatment-related adverse event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         10

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         10

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

IC signed;Age≥18 years;confirmed diagnosis of MM,ECOG PS≤2;LVEF≥45%;negative pregnancy test

recruitment Details

Patients participated between 15May2017 - 30Jul2018 (last follow-up cutoff date). The 1st dose/1st cycle was administered on 15May2017 and the last dose/last cycle on 23Jul2018. At cutoff date 10 patients had been included and treated with plitidepsin+BTZ+DXM and they were evaluable for safety. 8 of these were evaluable for the efficacy endpoint

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

Preserved source evidence · Not medical advice