NCT02004275 · BASELINE

Baseline characteristics

Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2023-12-01

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

denoms

counts
group Id
BG000
value
45
group Id
BG001
value
47
group Id
BG002
value
3
group Id
BG003
value
5
group Id
BG004
value
7
group Id
BG005
value
11
group Id
BG006
value
118
units
Participants

groups

description
Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
id
BG000
title
Phase II Arm I (Pomalidomide, Dexamethasone)
description
Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
BG001
title
Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib)
description
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.
id
BG002
title
Phase 1 Dose Level 1
description
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.
id
BG003
title
Phase 1 Dose Level 2
description
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.
id
BG004
title
Phase 1 Dose Level 3
description
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
id
BG005
title
Phase 1 Dose Level 4
description
Total of all reporting groups
id
BG006
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
41
upper Limit
85
value
65
group Id
BG001
lower Limit
41
upper Limit
83
value
67
group Id
BG002
lower Limit
57
upper Limit
72
value
64.0
group Id
BG003
lower Limit
47
upper Limit
77
value
63
group Id
BG004
lower Limit
59
upper Limit
69
value
65
group Id
BG005
lower Limit
51
upper Limit
80
value
69
group Id
BG006
lower Limit
41
upper Limit
85
value
66
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
25
group Id
BG002
value
1
group Id
BG003
value
1
group Id
BG004
value
4
group Id
BG005
value
4
group Id
BG006
value
52
title
Female
measurements
group Id
BG000
value
28
group Id
BG001
value
22
group Id
BG002
value
2
group Id
BG003
value
4
group Id
BG004
value
3
group Id
BG005
value
7
group Id
BG006
value
66
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
group Id
BG004
value
0
group Id
BG005
value
2
group Id
BG006
value
8
title
Hispanic or Latino
measurements
group Id
BG000
value
33
group Id
BG001
value
43
group Id
BG002
value
3
group Id
BG003
value
3
group Id
BG004
value
6
group Id
BG005
value
9
group Id
BG006
value
97
title
Not Hispanic or Latino
measurements
group Id
BG000
value
8
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
1
group Id
BG004
value
1
group Id
BG005
value
0
group Id
BG006
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
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
0
group Id
BG006
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
1
group Id
BG006
value
2
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
0
group Id
BG006
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
1
group Id
BG003
value
0
group Id
BG004
value
1
group Id
BG005
value
0
group Id
BG006
value
13
title
Black or African American
measurements
group Id
BG000
value
37
group Id
BG001
value
39
group Id
BG002
value
2
group Id
BG003
value
5
group Id
BG004
value
6
group Id
BG005
value
8
group Id
BG006
value
97
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
0
group Id
BG006
value
0
title
More than one race
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
2
group Id
BG006
value
6
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
45
group Id
BG001
value
47
group Id
BG002
value
3
group Id
BG003
value
5
group Id
BG004
value
7
group Id
BG005
value
11
group Id
BG006
value
118
units
Participants

groups

description
Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
id
BG000
title
Phase II Arm I (Pomalidomide, Dexamethasone)
description
Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
BG001
title
Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib)
description
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.
id
BG002
title
Phase 1 Dose Level 1
description
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.
id
BG003
title
Phase 1 Dose Level 2
description
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.
id
BG004
title
Phase 1 Dose Level 3
description
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
id
BG005
title
Phase 1 Dose Level 4
description
Total of all reporting groups
id
BG006
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
41
upper Limit
85
value
65
group Id
BG001
lower Limit
41
upper Limit
83
value
67
group Id
BG002
lower Limit
57
upper Limit
72
value
64.0
group Id
BG003
lower Limit
47
upper Limit
77
value
63
group Id
BG004
lower Limit
59
upper Limit
69
value
65
group Id
BG005
lower Limit
51
upper Limit
80
value
69
group Id
BG006
lower Limit
41
upper Limit
85
value
66
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
25
group Id
BG002
value
1
group Id
BG003
value
1
group Id
BG004
value
4
group Id
BG005
value
4
group Id
BG006
value
52
title
Female
measurements
group Id
BG000
value
28
group Id
BG001
value
22
group Id
BG002
value
2
group Id
BG003
value
4
group Id
BG004
value
3
group Id
BG005
value
7
group Id
BG006
value
66
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
group Id
BG004
value
0
group Id
BG005
value
2
group Id
BG006
value
8
title
Hispanic or Latino
measurements
group Id
BG000
value
33
group Id
BG001
value
43
group Id
BG002
value
3
group Id
BG003
value
3
group Id
BG004
value
6
group Id
BG005
value
9
group Id
BG006
value
97
title
Not Hispanic or Latino
measurements
group Id
BG000
value
8
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
1
group Id
BG004
value
1
group Id
BG005
value
0
group Id
BG006
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
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
0
group Id
BG006
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
1
group Id
BG006
value
2
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
0
group Id
BG006
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
1
group Id
BG003
value
0
group Id
BG004
value
1
group Id
BG005
value
0
group Id
BG006
value
13
title
Black or African American
measurements
group Id
BG000
value
37
group Id
BG001
value
39
group Id
BG002
value
2
group Id
BG003
value
5
group Id
BG004
value
6
group Id
BG005
value
8
group Id
BG006
value
97
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
0
group Id
BG006
value
0
title
More than one race
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
0
group Id
BG005
value
2
group Id
BG006
value
6
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants

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Preserved source evidence · Not medical advice