Participant flow

A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function · Source last updated 2026-07-01

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) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

   id

   FG000

   title

   Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)

2. description

   Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

   id

   FG001

   title

   Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)

3. description

   Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

   id

   FG002

   title

   Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)

4. description

   Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

   id

   FG003

   title

   Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)

5. description

   Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

   id

   FG004

   title

   Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         3

      type

      Ongoing at time of analysis

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         8

      comment

      All participants who signed the ICF, passed the screening, and entered the study.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         8

      comment

      All enrolled participants who received at least 1 dose of belantamab mafodotin.

      type

      Safety Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         8

      comment

      All participants in the Safety Population who had at least 80% non-missing expected plasma PK data during the Cycle 1 profile (i.e., all Cycle 1 timepoints and Cycle 2 Day 1 pre-dose).

      type

      Pharmacokinetic (PK) Evaluable Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         4

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The results presented are based on the data cut-off date of 21 April 2025. Those participants still benefiting from study drug in the opinion of their treating physician continue to receive study drug in the Post Analysis Continuation of Treatment (PACT) phase. Additional safety results will be provided within one year of study completion.

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

Preserved source evidence · Not medical advice