Participant flow

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17

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

groups

1. description

   Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 306.6 weeks).

   id

   FG000

   title

   Pd (Pomalidomide + Dexamethasone)

2. description

   Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 311.0 weeks).

   id

   FG001

   title

   IPd (Isatuximab + Pomalidomide + Dexamethasone)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Randomized and not treated

   2. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         22

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         118

      2. group Id

         FG001

         num Subjects

         107

      type

      Progressive disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Poor compliance to protocol

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      type

      Physician's decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      type

      Treatment extension study

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Unconfirmed disease progression per investigator

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Continue with therapy available commercially

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         153

      2. group Id

         FG001

         num Subjects

         154

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         149

      2. group Id

         FG001

         num Subjects

         152

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         153

      2. group Id

         FG001

         num Subjects

         154

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Randomization was stratified by age (less than \[\<\] 75 years versus greater than and equal to \[\>=\] 75 years) and number of previous lines of therapy (2 or 3 versus more than 3). "Reason for not completed" = "Reason for definitive treatment discontinuation."

recruitment Details

The study was conducted at 102 sites in 24 countries. A total of 387 participants were screened between 22 December 2016 and 01 February 2018. Out of which, 307 participants were randomized in 1:1 ratio to IPd (Isatuximab + Pomalidomide + Dexamethasone) and Pd (Pomalidomide + Dexamethasone) arms using an interactive response technology (IRT).

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Preserved source evidence · Not medical advice