NCT07217184 · OUTCOME
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM · Source last updated 2026-06-25
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 approximately 194 weeks What was measured Blood samples were collected for the analysis of hematology parameters. The laboratory parameters were graded according to CTCAE v 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. WBC: White blood cells.
Analysis population: Safety population. Only those participants who were measured and analyzed (i.e., contributed 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 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Reported measurements Anemia, Increase to G1 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 3 Not reported Not reported Not reported Not reported
Anemia, Increase to G2 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 3 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 4 Not reported Not reported Not reported Not reported
Anemia, Increase to G3 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported
Anemia, Increase to G4 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to G1 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to G2 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to G3 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to G4 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Lymphocyte decreased, Increase to G1 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported
Lymphocyte decreased, Increase to G2 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 4 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported
Lymphocyte decreased, Increase to G3 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported
Lymphocyte decreased, Increase to G4 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported
Lymphocyte increased, Increase to G1 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Lymphocyte increased, Increase to G2 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported
Lymphocyte increased, Increase to G3 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Lymphocyte increased, Increase to G4 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported
Neutrophil decreased, Increase to G1 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported
Neutrophil decreased, Increase to G2 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 3 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported
Neutrophil decreased, Increase to G3 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Neutrophil decreased, Increase to G4 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Platelet decreased, Increase to G1 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 5 Not reported Not reported Not reported Not reported
Platelet decreased, Increase to G2 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported
Platelet decreased, Increase to G3 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported
Platelet decreased, Increase to G4 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to G1 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to G2 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to G3 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to G4 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
WBC decreased, Increase to G1 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported
WBC decreased, Increase to G2 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 1 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 4 Not reported Not reported Not reported Not reported
WBC decreased, Increase to G3 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 2 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
WBC decreased, Increase to G4 Analysis denominator · Participants
Group Source count 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 10 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 9 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab 0 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 3 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Anemia, Increase to G1 categories measurements
group Id OG000
value 3
group Id OG001
value 2
group Id OG002
value 4 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Anemia, Increase to G2 categories measurements
group Id OG000
value 2
group Id OG001
value 1
group Id OG002
value 2 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Anemia, Increase to G3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Anemia, Increase to G4 categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Hemoglobin increased, Increase to G1 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Hemoglobin increased, Increase to G2 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Hemoglobin increased, Increase to G3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Hemoglobin increased, Increase to G4 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 2 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Lymphocyte decreased, Increase to G1 categories measurements
group Id OG000
value 2
group Id OG001
value 4
group Id OG002
value 2 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Lymphocyte decreased, Increase to G2 categories measurements
group Id OG000
value 2
group Id OG001
value 1
group Id OG002
value 2 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Lymphocyte decreased, Increase to G3 categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 2 denoms counts
group Id OG000
value 10
group Id OG001
value 9
group Id OG002
value 10
units Participants
title Lymphocyte decreased, Increase to G4 Show more (12 of 32) denoms counts
group Id OG000
value 10
group Id OG001
value 10
group Id OG002
value 10
units Participants
description Blood samples were collected for the analysis of hematology parameters. The laboratory parameters were graded according to CTCAE v 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. WBC: White blood cells. groups
description Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
id OG000
title 1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
description Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
id OG001
title 1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
description Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
id OG002
title 1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
param Type COUNT_OF_PARTICIPANTS
population Description Safety population. Only those participants who were measured and analyzed (i.e., contributed 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 approximately 194 weeks
title DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
type PRIMARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle