Participant flow

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma · Source last updated 2022-01-10

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

groups

1. description

   Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

   id

   FG000

   title

   Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Lack of Efficacy

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         504

      type

      Progressive Disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         57

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         52

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         31

      type

      Miscellaneous

   7. reasons

      1. group Id

         FG000

         num Subjects

         21

      type

      Withdrawal by Subject

   8. reasons

      1. group Id

         FG000

         num Subjects

         8

      type

      Transition to Commercial Treatment

   9. reasons

      1. group Id

         FG000

         num Subjects

         6

      type

      Participants Did Not Receive Study Drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         682

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         676

      type

      Received Study Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      comment

      Completed = did not discontinue treatment Note: "Reason for Not Completed" below equates to "Reason for Treatment Discontinuation"

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         682

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Study participants had to have either refractory or relapsed and refractory disease, defined as documented disease progression during or within 60 days of completing their last myeloma therapy to be eligible to participate in the trial.

recruitment Details

The study was conducted at 112 sites: 4 in Austria, 7 in Belgium, 3 in Denmark, 1 in Estonia, 2 in Finland, 13 in France, 17 in Germany, 1 in Greece, 3 in Ireland, 15 in Italy, 5 in the Netherlands, 2 in Norway, 3 in Poland, 4 in Portugal, 1 in Slovakia, 15 in Spain, 2 in Sweden, 3 in Switzerland, 2 in Turkey, and 9 in the United Kingdom.

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

Preserved source evidence · Not medical advice