NCT03828292 · OUTCOME
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments · Source last updated 2025-08-19
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 141 weeks
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, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample.
Analysis population: All treated population. Only those participants with data available at specified category have been analyzed.
Groups in this outcome
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 4 |
|---|
Reported measurements
Occult Blood, No Change/Decreased
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 2 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Occult Blood, Increase to SMALL
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 2 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Occult Blood, Increase to MODERATE
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 2 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Occult Blood, Increase to LARGE
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 2 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Protein, No Change/Decreased
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 3 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Protein, Increase to +-
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 3 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Protein, Increase to 1+
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 3 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Protein, Increase to 2+
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 3 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Protein, Increase to 3+
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 3 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Protein, Unknown
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 4 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Occult Blood, No Change/Decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Occult Blood, Increase to SMALL
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Occult Blood, Increase to MODERATE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Occult Blood, Increase to LARGE
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Protein, No Change/Decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Protein, Increase to +-
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Protein, Increase to 1+
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Protein, Increase to 2+
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Protein, Increase to 3+
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- Protein, Unknown
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- 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, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample.
- groups
- description
- Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
- id
- OG000
- title
- Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
- description
- Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
- id
- OG001
- title
- Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated population. Only those participants with data available at specified category have been analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to approximately 141 weeks
- title
- Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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