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 Nirogacestat in Participants With RRMM · Source last updated 2026-05-06
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 253 weeks
What was measured
Blood samples were collected for evaluation of hematology parameters including Anemia (An), Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. 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 increases 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.
Analysis population: Safety Population.
Groups in this outcome
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
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
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
10
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
1
Reported measurements
An, Increase to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
An, Increase to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
3
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
An, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
3
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
An, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
HbI, Increase to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
HbI, Increase to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
HbI, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
HbI, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LyD, Increase to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LyD, Increase to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
4
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LyD, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
5
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LyD, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LyI, Increase to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LyI, Increase to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LyI, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LyI, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
NeuD, Increase to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
3
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
3
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
NeuD, Increase to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
NeuD, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
NeuD, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
PD, Increase to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
3
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
PD, Increase to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
PD, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
PD, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LC, Increase to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LC, Increase to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LC, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
LC, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
WBCD, Increase to Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
WBCD, Increase to Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
5
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
3
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
2
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
WBCD, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
1
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
WBCD, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
title
An, Increase to Grade 1
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
0
title
An, Increase to Grade 2
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
title
An, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
An, Increase to Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
HbI, Increase to Grade 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
HbI, Increase to Grade 2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
HbI, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
HbI, Increase to Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
title
LyD, Increase to Grade 1
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
4
group Id
OG003
value
1
group Id
OG004
value
0
title
LyD, Increase to Grade 2
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
0
title
LyD, Increase to Grade 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
title
LyD, Increase to Grade 4
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
4
group Id
OG002
value
10
group Id
OG003
value
10
group Id
OG004
value
1
units
Participants
description
Blood samples were collected for evaluation of hematology parameters including Anemia (An), Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. 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 increases 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.
groups
description
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
OG000
title
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
description
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
OG001
title
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
description
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
OG002
title
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
description
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
OG003
title
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
description
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
OG004
title
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 253 weeks
title
DE Phase: Number of Participants With Worst-case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Triangle