NCT00522392 · OUTCOME

Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR])

Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone · Source last updated 2015-06-26

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

Measure: NUMBER
Unit: Proportion of patients
Interval / dispersion: 95% Confidence Interval
Time frame: Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years

What was measured

CR: Patients with complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. To be considered CR, patients must meet all of the following criteria: * Negative immunofixation on the serum and urine at two consecutive times * Disappearance of any soft tissue plasmacytomas * ≤5% plasma cells in bone marrow * If serum and urine M protein are unmeasurable and the immunoglobulin free light chain (FLC) parameter is being used, patients must have a normal ratio of 0.26-1.65 at two consecutive times VGPR: * Serum and urine M-component detectable by immunofixation but not on electrophoresis OR * \>=90% reduction in serum M-component plus urine M-component \<100 mg per 24 hours (by SPEP and UPEP) * If the serum and urine M protein are unmeasurable and the immunoglobulin FLC parameter is being used, a \>90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M protein criteria

Analysis population: Patients with measurable disease at randomization were included in this analysis.

Groups in this outcome

Arm A (VRD)

Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin. bortezomib: Given IV lenalidomide: Given PO dexamethasone: Given PO

Arm B (VD)

Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. bortezomib: Given IV dexamethasone: Given PO

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
Arm A (VRD)	16
Arm B (VD)	16

Reported measurements

Source class 1

Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A (VRD)	0.625	Not reported	0.354	0.848	Not reported
Arm B (VD)	0.188	Not reported	0.041	0.457	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Num Sides
TWO_SIDED
group Description
Fisher's exact test was used to compare the response rates between the two arms.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.029
statistical Method
Fisher Exact
tested Non Inferiority
false

Complete source fields

analyses

ci Num Sides
TWO_SIDED
group Description
Fisher's exact test was used to compare the response rates between the two arms.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.029
statistical Method
Fisher Exact
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
0.354
upper Limit
0.848
value
0.625
group Id
OG001
lower Limit
0.041
upper Limit
0.457
value
0.188

denoms

counts
group Id
OG000
value
16
group Id
OG001
value
16
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin. bortezomib: Given IV lenalidomide: Given PO dexamethasone: Given PO
id
OG000
title
Arm A (VRD)
description
Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. bortezomib: Given IV dexamethasone: Given PO
id
OG001
title
Arm B (VD)

param Type

NUMBER

population Description

Patients with measurable disease at randomization were included in this analysis.

reporting Status

POSTED

time Frame

Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years

title

Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR])

type

SECONDARY

unit Of Measure

Proportion of patients

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

Preserved source evidence · Not medical advice