Participant flow

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma · Source last updated 2026-04-23

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

groups

1. description

   Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.

   id

   FG000

   title

   Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)

2. description

   Participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.

   id

   FG001

   title

   Daratumumab + Bor + Dex

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         77

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         10

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         26

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         169

      2. group Id

         FG001

         num Subjects

         135

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         243

      2. group Id

         FG001

         num Subjects

         251

      comment

      Intent-to-Treat (ITT) Population included of all randomized participants whether or not randomized treatment was administered.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         242

      2. group Id

         FG001

         num Subjects

         246

      comment

      Participants randomized who took at least 1 dose of study treatment.

      type

      Safety Population

   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

         243

      2. group Id

         FG001

         num Subjects

         251

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The results presented are until the primary completion date. Additional results will be provided within a year of study completion.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice