Skip to content
← Full study record

NCT07150104 · OUTCOME

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

Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone in Participants With RRMM · Source last updated 2026-06-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline (Day 1) and up to 137 weeks

What was measured

Blood samples were collected for the analysis of chemistry parameters. 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. CPK = creatine kinase.

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

0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14

Reported measurements

Hypoglycemia, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone4Not reportedNot reportedNot reportedNot reported
Hypoglycemia, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypoglycemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypoglycemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone4Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone4Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
CPK increased, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone2Not reportedNot reportedNot reportedNot reported
CPK increased, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone3Not reportedNot reportedNot reportedNot reported
CPK increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
CPK increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hyperkalemia, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone2Not reportedNot reportedNot reportedNot reported
Hyperkalemia, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Hyperkalemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hyperkalemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Blood lactate dehydrogenase increased, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone10Not reportedNot reportedNot reportedNot reported
Blood lactate dehydrogenase increased, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Blood lactate dehydrogenase increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Blood lactate dehydrogenase increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone2Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone4Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypernatremia, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone2Not reportedNot reportedNot reportedNot reported
Hypernatremia, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypernatremia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypernatremia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone2Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Chronic Kidney Disease, Increase to Grade 1

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Chronic Kidney Disease, Increase to Grade 2

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone3Not reportedNot reportedNot reportedNot reported
Chronic Kidney Disease, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Chronic Kidney Disease, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Hypoglycemia, Increase to Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Hypoglycemia, Increase to Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Hypoglycemia, Increase to Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Hypoglycemia, Increase to Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Hypoalbuminemia, Increase to Grade 1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Hypoalbuminemia, Increase to Grade 2
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Hypoalbuminemia, Increase to Grade 3
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Hypoalbuminemia, Increase to Grade 4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CPK increased, Increase to Grade 1
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CPK increased, Increase to Grade 2
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CPK increased, Increase to Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CPK increased, Increase to Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Blood samples were collected for the analysis of chemistry parameters. 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. CPK = creatine kinase.
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
    id
    OG000
    title
    0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone
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 137 weeks
title
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice