Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments · Source last updated 2025-08-19
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 141 weeks
What was measured
Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.03. Grade (G)1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Analysis population: All treated population. Only those participants with data available at specified category have been analyzed.
Groups in this outcome
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
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
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
4
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
4
Reported measurements
Hyperglycemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
4
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
4
Not reported
Not reported
Not reported
Not reported
Hyperglycemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hyperglycemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CK, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CK, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
CK, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Creatinine, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Creatinine, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Creatinine, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
GGT, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
2
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
2
Not reported
Not reported
Not reported
Not reported
GGT, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
2
Not reported
Not reported
Not reported
Not reported
GGT, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypermagnesemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypermagnesemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypermagnesemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Phosphate, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
2
Not reported
Not reported
Not reported
Not reported
Phosphate, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Phosphate, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hyperkalemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
2
Not reported
Not reported
Not reported
Not reported
Hyperkalemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Hyperkalemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypokalemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
2
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
2
Not reported
Not reported
Not reported
Not reported
Hypokalemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Hypokalemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypernatremia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypernatremia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypernatremia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypoglycemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
2
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Hypoglycemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypoglycemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hyponatremia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
3
Not reported
Not reported
Not reported
Not reported
Hyponatremia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Hyponatremia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hyperuricemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hyperuricemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hyperuricemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
ALT, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
3
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
3
Not reported
Not reported
Not reported
Not reported
ALT, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
ALT, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Albumin, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
2
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Albumin, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Albumin, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
ALP, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
2
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
ALP, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
ALP, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
AST, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
4
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
4
Not reported
Not reported
Not reported
Not reported
AST, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
AST, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Bilirubin, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Bilirubin, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Bilirubin, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypercalcemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
1
Not reported
Not reported
Not reported
Not reported
Hypercalcemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypercalcemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypocalcemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
2
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypocalcemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Hypocalcemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
title
Hyperglycemia, Any Grade Increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hyperglycemia, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hyperglycemia, Increase to Grade 4
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
CK, Any Grade Increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
CK, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
CK, Increase to Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Creatinine, Any Grade Increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Creatinine, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Creatinine, Increase to Grade 4
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
title
GGT, Any Grade Increase
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
title
GGT, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
GGT, Increase to Grade 4
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
4
units
Participants
description
Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.03. Grade (G)1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
groups
description
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
id
OG000
title
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
description
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
id
OG001
title
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated population. Only those participants with data available at specified category have been analyzed.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 141 weeks
title
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters