NCT03151811 · BASELINE

Baseline characteristics

A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide · Source last updated 2024-01-30

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

denoms

counts
group Id
BG000
value
246
group Id
BG001
value
249
group Id
BG002
value
495
units
Participants

groups

description
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Melflufen: Intravenous infusion Dexamethasone: Oral tablets
id
BG000
title
Arm A: Melflufen+Dexamethasone
description
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Pomalidomide: Oral capsules Dexamethasone: Oral tablets
id
BG001
title
Arm B: Pomalidomide+Dexamethasone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
96
group Id
BG001
value
85
group Id
BG002
value
181
title
Between 18 and 65 years
measurements
group Id
BG000
value
150
group Id
BG001
value
164
group Id
BG002
value
314
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
41
upper Limit
91
value
68
group Id
BG001
lower Limit
39
upper Limit
87
value
68
group Id
BG002
lower Limit
39
upper Limit
91
value
68
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
107
group Id
BG001
value
109
group Id
BG002
value
216
title
Female
measurements
group Id
BG000
value
139
group Id
BG001
value
140
group Id
BG002
value
279
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
5
group Id
BG002
value
13
title
Hispanic or Latino
measurements
group Id
BG000
value
232
group Id
BG001
value
237
group Id
BG002
value
469
title
Not Hispanic or Latino
measurements
group Id
BG000
value
6
group Id
BG001
value
7
group Id
BG002
value
13
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
8
group Id
BG001
value
13
group Id
BG002
value
21
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
Black or African American
measurements
group Id
BG000
value
224
group Id
BG001
value
222
group Id
BG002
value
446
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
10
group Id
BG001
value
10
group Id
BG002
value
20
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
10
group Id
BG002
value
20
title
Romania
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
14
group Id
BG002
value
31
title
Hungary
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
30
group Id
BG002
value
59
title
Czechia
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
15
group Id
BG002
value
26
title
United States
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
10
title
United Kingdom
categories
measurements
group Id
BG000
value
22
group Id
BG001
value
20
group Id
BG002
value
42
title
Spain
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
39
group Id
BG002
value
79
title
Russia
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
23
group Id
BG002
value
46
title
Greece
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Netherlands
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Austria
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
15
title
South Korea
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Belgium
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

population Description

All patients that were enrolled defined as patients assigned a unique patient number by Interactive Response Technology system at the time of enrollment.

Complete source fields

denoms

counts
group Id
BG000
value
246
group Id
BG001
value
249
group Id
BG002
value
495
units
Participants

groups

description
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Melflufen: Intravenous infusion Dexamethasone: Oral tablets
id
BG000
title
Arm A: Melflufen+Dexamethasone
description
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Pomalidomide: Oral capsules Dexamethasone: Oral tablets
id
BG001
title
Arm B: Pomalidomide+Dexamethasone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
96
group Id
BG001
value
85
group Id
BG002
value
181
title
Between 18 and 65 years
measurements
group Id
BG000
value
150
group Id
BG001
value
164
group Id
BG002
value
314
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
41
upper Limit
91
value
68
group Id
BG001
lower Limit
39
upper Limit
87
value
68
group Id
BG002
lower Limit
39
upper Limit
91
value
68
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
107
group Id
BG001
value
109
group Id
BG002
value
216
title
Female
measurements
group Id
BG000
value
139
group Id
BG001
value
140
group Id
BG002
value
279
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
5
group Id
BG002
value
13
title
Hispanic or Latino
measurements
group Id
BG000
value
232
group Id
BG001
value
237
group Id
BG002
value
469
title
Not Hispanic or Latino
measurements
group Id
BG000
value
6
group Id
BG001
value
7
group Id
BG002
value
13
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
8
group Id
BG001
value
13
group Id
BG002
value
21
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
Black or African American
measurements
group Id
BG000
value
224
group Id
BG001
value
222
group Id
BG002
value
446
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
10
group Id
BG001
value
10
group Id
BG002
value
20
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
10
group Id
BG002
value
20
title
Romania
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
14
group Id
BG002
value
31
title
Hungary
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
30
group Id
BG002
value
59
title
Czechia
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
15
group Id
BG002
value
26
title
United States
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
10
title
United Kingdom
categories
measurements
group Id
BG000
value
22
group Id
BG001
value
20
group Id
BG002
value
42
title
Spain
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
39
group Id
BG002
value
79
title
Russia
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
23
group Id
BG002
value
46
title
Greece
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Netherlands
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Austria
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
15
title
South Korea
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Belgium
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

population Description

All patients that were enrolled defined as patients assigned a unique patient number by Interactive Response Technology system at the time of enrollment.

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

Preserved source evidence · Not medical advice