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NCT03544281 · OUTCOME

Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2025-03-18

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 4.5 years

What was measured

Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased and increase to trace, 1+, 2+, 3+, \>3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

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: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex

Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 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: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16

Reported measurements

Occult Blood, No Change/Decreased

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex5Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex8Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex9Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex4Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex11Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex7Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex12Not reportedNot reportedNot reportedNot reported
Occult Blood, Increase to TRACE

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex3Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex4Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex5Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Occult Blood, Increase to 1+

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex4Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex3Not reportedNot reportedNot reportedNot reported
Occult Blood, Increase to 2+

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex3Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Occult Blood, Increase to 3+

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Occult Blood, Increase to >3+

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Protein, No Change/Decreased

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex5Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex7Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex3Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex5Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex5Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex5Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex8Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex4Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex5Not reportedNot reportedNot reportedNot reported
Protein, Increase to TRACE

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Protein, Increase to 1+

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex3Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex4Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex4Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex6Not reportedNot reportedNot reportedNot reported
Protein, Increase to 2+

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex3Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex3Not reportedNot reportedNot reportedNot reported
Protein, Increase to 3+

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex3Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex3Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Protein, Increase to >3+

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex13
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex1Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        8
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        9
      9. group Id
        OG008
        value
        4
      10. group Id
        OG009
        value
        11
      11. group Id
        OG010
        value
        7
      12. group Id
        OG011
        value
        12
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        11
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Occult Blood, No Change/Decreased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        11
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Occult Blood, Increase to TRACE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        4
      11. group Id
        OG010
        value
        2
      12. group Id
        OG011
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        11
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Occult Blood, Increase to 1+
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        2
      12. group Id
        OG011
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        11
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Occult Blood, Increase to 2+
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        11
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Occult Blood, Increase to 3+
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        11
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Occult Blood, Increase to >3+
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        6
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        8
      11. group Id
        OG010
        value
        4
      12. group Id
        OG011
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        12
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Protein, No Change/Decreased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        12
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Protein, Increase to TRACE
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        4
      11. group Id
        OG010
        value
        2
      12. group Id
        OG011
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        12
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Protein, Increase to 1+
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        2
      12. group Id
        OG011
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        12
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Protein, Increase to 2+
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        3
      12. group Id
        OG011
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        12
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Protein, Increase to 3+
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        13
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        12
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        11
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    Protein, Increase to >3+
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      13
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      12
    7. group Id
      OG006
      value
      12
    8. group Id
      OG007
      value
      12
    9. group Id
      OG008
      value
      12
    10. group Id
      OG009
      value
      18
    11. group Id
      OG010
      value
      11
    12. group Id
      OG011
      value
      16
    units
    Participants
description
Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased and increase to trace, 1+, 2+, 3+, \>3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
groups
  1. description
    Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
    id
    OG000
    title
    Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
  2. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG001
    title
    Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
  3. description
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG002
    title
    Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
  4. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG003
    title
    Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
  5. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG004
    title
    Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
  6. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG005
    title
    Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
  7. description
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG006
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
  8. description
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG007
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
  9. description
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG008
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
  10. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG009
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
  11. description
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG010
    title
    Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
  12. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG011
    title
    Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
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 4.5 years
title
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice