NCT00558896 · OUTCOME

The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)

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: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Duration of study (up to 3 years)

What was measured

Response that was confirmed on 2 consecutive evaluations * Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow. * Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.

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 participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Relapsed Myeloma (<4 Prior Regimens): Low Dose	39	Not reported	Not reported	Not reported	Not reported
Lenalidomide Refractory Myeloma: Low Dose	11	Not reported	Not reported	Not reported	Not reported
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose	9	Not reported	Not reported	Not reported	Not reported
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose	10	Not reported	Not reported	Not reported	Not reported
Relapsed Myeloma (< 4 Prior Regimens): High Dose	23	Not reported	Not reported	Not reported	Not reported
Relapsed/Refractory Myeloma: High Dose	25	Not reported	Not reported	Not reported	Not reported
Relapsed Amyloidosis: Low Dose	16	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
39
group Id
OG001
value
11
group Id
OG002
value
9
group Id
OG003
value
10
group Id
OG004
value
23
group Id
OG005
value
25
group Id
OG006
value
16

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

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

NUMBER

reporting Status

POSTED

time Frame

Duration of study (up to 3 years)

title

The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)

type

PRIMARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice