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NCT04398745 · OUTCOME

Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline (Day 1) and up to approx. 236 weeks

What was measured

Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade was defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Increase to a maximum grade of 3 and 4 is presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.

Analysis population: Safety population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.

Groups in this outcome

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

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.

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

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.

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

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.

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

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.

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

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)10
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)8
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)3
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)5
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)7

Reported measurements

Anemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)2Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)2Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)1Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)2Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)3Not reportedNot reportedNot reportedNot reported
Anemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Eosinophilia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Eosinophilia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Hemoglobin increased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)1Not reportedNot reportedNot reportedNot reported
Hemoglobin increased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Leukocytosis, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Leukocytosis, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)2Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)1Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)2Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)1Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)1Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)1Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)1Not reportedNot reportedNot reportedNot reported
Platelet count decreased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)2Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)1Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)1Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)2Not reportedNot reportedNot reportedNot reported
Platelet count decreased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)2Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)2Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
White blood cell decreased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)1Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)1Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)1Not reportedNot reportedNot reportedNot reported
White blood cell decreased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)0Not reportedNot reportedNot reportedNot reported
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        3
    title
    Anemia, Increase to Grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Anemia, Increase to Grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Eosinophilia, Increase to Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Eosinophilia, Increase to Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
    title
    Hemoglobin increased, Increase to Grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Hemoglobin increased, Increase to Grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Leukocytosis, Increase to Grade 3
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Leukocytosis, Increase to Grade 4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
    title
    Lymphocyte count decreased, Increase to Grade 3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Lymphocyte count decreased, Increase to Grade 4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
    title
    Lymphocyte count increased, Increase to Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Lymphocyte count increased, Increase to Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      7
    units
    Participants
description
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade was defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Increase to a maximum grade of 3 and 4 is presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
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
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    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
    OG004
    title
    Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approx. 236 weeks
title
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice