NCT00558896 · OUTCOME

Progression Free Survival (PFS)

CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis · Source last updated 2018-04-18

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Duration of study (up to 5 years)

What was measured

PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method. Progression was defined as any one or more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25% increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas

Groups in this outcome

Relapsed Myeloma (<4 Prior Regimens): Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Lenalidomide Refractory Myeloma: Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose

Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Relapsed Myeloma (< 4 Prior Regimens): High Dose

Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Relapsed/Refractory Myeloma: High Dose

Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Relapsed Amyloidosis: Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

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

Analysis denominator · Participants

Group	Source count
Relapsed Myeloma (<4 Prior Regimens): Low Dose	60
Lenalidomide Refractory Myeloma: Low Dose	34
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose	35
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose	35
Relapsed Myeloma (< 4 Prior Regimens): High Dose	60
Relapsed/Refractory Myeloma: High Dose	120
Relapsed Amyloidosis: Low Dose	33

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Relapsed Myeloma (<4 Prior Regimens): Low Dose	13	Not reported	8.1	20.4	Not reported
Lenalidomide Refractory Myeloma: Low Dose	5	Not reported	2.7	10.3	Not reported
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose	6.4	Not reported	3.2	8.0	Not reported
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose	3.3	Not reported	1.9	6.2	Not reported
Relapsed Myeloma (< 4 Prior Regimens): High Dose	7.7	Not reported	4.8	10.8	Not reported
Relapsed/Refractory Myeloma: High Dose	4.3	Not reported	2.9	5	Not reported
Relapsed Amyloidosis: Low Dose	14.1	Not reported	9.7	21.1	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
8.1
upper Limit
20.4
value
13
group Id
OG001
lower Limit
2.7
upper Limit
10.3
value
5
group Id
OG002
lower Limit
3.2
upper Limit
8.0
value
6.4
group Id
OG003
lower Limit
1.9
upper Limit
6.2
value
3.3
group Id
OG004
lower Limit
4.8
upper Limit
10.8
value
7.7
group Id
OG005
lower Limit
2.9
upper Limit
5
value
4.3
group Id
OG006
lower Limit
9.7
upper Limit
21.1
value
14.1

denoms

counts
group Id
OG000
value
60
group Id
OG001
value
34
group Id
OG002
value
35
group Id
OG003
value
35
group Id
OG004
value
60
group Id
OG005
value
120
group Id
OG006
value
33
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
id
OG000
title
Relapsed Myeloma (<4 Prior Regimens): Low Dose
description
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
id
OG001
title
Lenalidomide Refractory Myeloma: Low Dose
description
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
id
OG002
title
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
description
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
id
OG003
title
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
description
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
id
OG004
title
Relapsed Myeloma (< 4 Prior Regimens): High Dose
description
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
id
OG005
title
Relapsed/Refractory Myeloma: High Dose
description
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
id
OG006
title
Relapsed Amyloidosis: Low Dose

param Type

MEDIAN

reporting Status

POSTED

time Frame

Duration of study (up to 5 years)

title

Progression Free Survival (PFS)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice