NCT03416374 · OUTCOME

Percentage of Participants Who Achieved VGPR or Better (CR + VGPR)

A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy · Source last updated 2022-09-27

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

Measure: NUMBER
Unit: Percentage of Participants
Interval / dispersion: 95% Confidence Interval
Time frame: Up to 39 months as a maximum

What was measured

VGPR or better (CR + VGPR) were assessed by IMWG Criteria. Per IMWG criteria, PR (partial response): ≥50% reduction of serum M protein+reduction in 24-hour urinary M protein by ≥90%/ to \<200 mg/24-hour or ≥50% decrease in difference between involved and uninvolved free light chain (FLC) levels/ ≥50% reduction in bone marrow plasma cells, if ≥30% at baseline/ ≥50% reduction in size of soft tissue plasmacytomas. VGPR (very good PR): serum+urine M-protein detectable by immunofixation but not on electrophoresis/ ≥90% reduction in serum M-protein+urine Mprotein level \<100 mg/24-hour. CR (complete response): negative immunofixation on serum+urine+disappearance of soft tissue plasmacytomas+\<5% plasma cells in bone marrow.

Analysis population: Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.

Groups in this outcome

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

[Overall]; Combination Therapy + Ixazomib Therapy

Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

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
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy	6
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy	39
[Overall]; Combination Therapy + Ixazomib Therapy	45

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy	33.3	Not reported	4.3	77.7	Not reported
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy	43.6	Not reported	27.8	60.4	Not reported
[Overall]; Combination Therapy + Ixazomib Therapy	42.2	Not reported	27.7	57.8	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
4.3
upper Limit
77.7
value
33.3
group Id
OG001
lower Limit
27.8
upper Limit
60.4
value
43.6
group Id
OG002
lower Limit
27.7
upper Limit
57.8
value
42.2

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
39
group Id
OG002
value
45
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
id
OG000
title
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
description
Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
id
OG001
title
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
description
Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
id
OG002
title
[Overall]; Combination Therapy + Ixazomib Therapy

param Type

NUMBER

population Description

Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.

reporting Status

POSTED

time Frame

Up to 39 months as a maximum

title

Percentage of Participants Who Achieved VGPR or Better (CR + VGPR)

type

SECONDARY

unit Of Measure

Percentage of Participants

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Preserved source evidence · Not medical advice