Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03848845 · OUTCOME

Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2024-04-09

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 178 weeks

What was measured

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Analysis population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Groups in this outcome

Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion

Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

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

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27

Reported measurements

Hyperglycemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
Hyperglycemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hyperglycemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypoglycemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion4Not reportedNot reportedNot reportedNot reported
Hypoglycemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypoglycemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
ALT increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion5Not reportedNot reportedNot reportedNot reported
ALT increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
ALT increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion9Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion9Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
AST increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion20Not reportedNot reportedNot reportedNot reported
AST increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
AST increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion3Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion3Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion3Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
CPK increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion4Not reportedNot reportedNot reportedNot reported
CPK increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
CPK increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Creatinine increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion7Not reportedNot reportedNot reportedNot reported
Creatinine increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Creatinine increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
GGT increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion10Not reportedNot reportedNot reportedNot reported
GGT increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
GGT increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion6Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypophosphatemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion3Not reportedNot reportedNot reportedNot reported
Hypophosphatemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
Hypophosphatemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hyperkalemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hyperkalemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hyperkalemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypokalemia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion4Not reportedNot reportedNot reportedNot reported
Hypokalemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
Hypokalemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypernatremia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypernatremia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hypernatremia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Hyponatremia, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion3Not reportedNot reportedNot reportedNot reported
Hyponatremia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
Hyponatremia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Hyperglycemia, Any Grade Increase
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Hyperglycemia, Increase to Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Hyperglycemia, Increase to Grade 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Hypoglycemia, Any Grade Increase
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Hypoglycemia, Increase to Grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Hypoglycemia, Increase to Grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    ALT increased, Any Grade Increase
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    ALT increased, Increase to Grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    ALT increased, Increase to Grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Hypoalbuminemia, Any Grade Increase
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Hypoalbuminemia, Increase to Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Hypoalbuminemia, Increase to Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
groups
  1. description
    Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
    id
    OG000
    title
    Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Population. Only those participants with data available at specified time points have been analyzed.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 178 weeks
title
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice