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NCT07084896 · OUTCOME

CE Phase: Number of Participants With Worst-Case Chemistry 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 clinical chemistry parameters including Hypoglycemia (HG), Hypoalbuminemia (HA), Creatinine Kinase increased (CPKi), Hyperkalemia (HK), Blood lactate dehydrogenase Increased (BLDi), Hypermagnesemia (HyperM), Hypomagnesemia (HypoM), Hypernatremia (HyperN), Hypercalcemia (HyperC), Hypocalcemia (HypoC) and Chronic Kidney Disease (CKD). The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; 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.

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

CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat

In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin 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 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.

CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W

In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles 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
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	34
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	37

Reported measurements

HG, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	7	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	2	Not reported	Not reported	Not reported	Not reported

HG, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HG, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HG, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HA, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	2	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	3	Not reported	Not reported	Not reported	Not reported

HA, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	3	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	3	Not reported	Not reported	Not reported	Not reported

HA, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	1	Not reported	Not reported	Not reported	Not reported

HA, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

CPKi, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	31
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	33

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	7	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	9	Not reported	Not reported	Not reported	Not reported

CPKi, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	31
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	33

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	1	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	4	Not reported	Not reported	Not reported	Not reported

CPKi, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	31
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	33

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

CPKi, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	31
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	33

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	1	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HK, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	5	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	3	Not reported	Not reported	Not reported	Not reported

HK, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	1	Not reported	Not reported	Not reported	Not reported

HK, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	1	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HK, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

BLDi, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	18	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	24	Not reported	Not reported	Not reported	Not reported

BLDi, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

BLDi, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

BLDi, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HyperM, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	6	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	3	Not reported	Not reported	Not reported	Not reported

HyperM, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HyperM, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	1	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HyperM, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HypoM, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	6	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	5	Not reported	Not reported	Not reported	Not reported

HypoM, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	1	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HypoM, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HypoM, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HyperN, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	7	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	2	Not reported	Not reported	Not reported	Not reported

HyperN, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HyperN, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HyperN, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HyperC, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	4	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	7	Not reported	Not reported	Not reported	Not reported

HyperC, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	2	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HyperC, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	2	Not reported	Not reported	Not reported	Not reported

HyperC, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	1	Not reported	Not reported	Not reported	Not reported

HypoC, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	10	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	7	Not reported	Not reported	Not reported	Not reported

HypoC, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	2	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	2	Not reported	Not reported	Not reported	Not reported

HypoC, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	1	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

HypoC, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	36

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	1	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

CKD, Increase to Grade 1

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	24
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	27

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	0	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

CKD, Increase to Grade 2

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	24
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	27

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	2	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	9	Not reported	Not reported	Not reported	Not reported

CKD, Increase to Grade 3

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	24
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	27

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	6	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	1	Not reported	Not reported	Not reported	Not reported

CKD, Increase to Grade 4

Analysis denominator · Participants

Group	Source count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	24
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	27

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat	1	Not reported	Not reported	Not reported	Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
7
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
36
units
Participants
title
HG, Increase to Grade 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
36
units
Participants
title
HG, Increase to Grade 2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
36
units
Participants
title
HG, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
36
units
Participants
title
HG, Increase to Grade 4
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
36
units
Participants
title
HA, Increase to Grade 1
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
36
units
Participants
title
HA, Increase to Grade 2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
36
units
Participants
title
HA, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
36
units
Participants
title
HA, Increase to Grade 4
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
9
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
33
units
Participants
title
CPKi, Increase to Grade 1
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
33
units
Participants
title
CPKi, Increase to Grade 2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
33
units
Participants
title
CPKi, Increase to Grade 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
33
units
Participants
title
CPKi, Increase to Grade 4

denoms

counts
group Id
OG000
value
34
group Id
OG001
value
37
units
Participants

description

Blood samples were collected for evaluation of clinical chemistry parameters including Hypoglycemia (HG), Hypoalbuminemia (HA), Creatinine Kinase increased (CPKi), Hyperkalemia (HK), Blood lactate dehydrogenase Increased (BLDi), Hypermagnesemia (HyperM), Hypomagnesemia (HypoM), Hypernatremia (HyperN), Hypercalcemia (HyperC), Hypocalcemia (HypoC) and Chronic Kidney Disease (CKD). The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; 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.

groups

description
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin 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 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
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
description
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
id
OG001
title
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W

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 253 weeks

title

CE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice