Participant flow

Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex · Source last updated 2025-12-19

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

groups

1. description

   Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

   id

   FG000

   title

   Daratumumab+Pomalidomide+Dexamethasone

2. description

   Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles

   id

   FG001

   title

   Pomalidomide + Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         7

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         12

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         66

      2. group Id

         FG001

         num Subjects

         87

      type

      Lack of Efficacy

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         7

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      randomized but not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         151

      2. group Id

         FG001

         num Subjects

         153

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         149

      2. group Id

         FG001

         num Subjects

         150

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         60

      2. group Id

         FG001

         num Subjects

         33

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         91

      2. group Id

         FG001

         num Subjects

         120

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Patients were randomly allocated to 1 of the 2 arms (Pd or DPd). 7 patients started with daratumumab IV. The study was amended to daratumumab SC formulation. Of those 7 patients, 4 switched to daratumumab SC and 3 discontinued treatment before the study was amended to SC administration. All other daratumumab-treated patients (142 of 149 DPd subjects) received only daratumumab SC. In summary, almost all patients (146 of 149) that were treated in the DPd arm received daratumumab SC.

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Preserved source evidence · Not medical advice