Participant flow

A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) · Source last updated 2018-10-16

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

groups

1. description

   Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.

   id

   FG000

   title

   Daratumumab and Durvalumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         14

      type

      Progressive Disease (PD)

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Miscellaneous

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         18

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         18

      type

      NOT COMPLETED

   title

   Treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Study Terminated by Sponsor

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. comment

         1 participant died in Cycle 1 due to PD prior to evaluation.

         group Id

         FG000

         num Subjects

         17

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         10

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         7

      type

      NOT COMPLETED

   title

   Follow-Up Period

pre Assignment Details

Eligible participants included those with relapsed and refractory multiple myeloma (RRMM) who progressed on daratumumab (DARA) while on a DARA-containing regimen as the most recent multiple myeloma (MM) therapy. Participants had to have received at least 3 prior anti-myeloma therapies.

recruitment Details

The study was conducted at 8 sites in 4 countries including Greece, Spain, Sweden and the United States, from 14 March 2017 to 04 December 2017

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

Preserved source evidence · Not medical advice