NCT00790842 · OUTCOME

Duration of Response

Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction · Source last updated 2018-10-24

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

Measure: MEDIAN
Unit: Months
Interval / dispersion: Inter-Quartile Range
Time frame: 56 months

What was measured

Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.

Analysis population: Patients treated at the recommended phase II dose who experienced a response to treatment

Groups in this outcome

Group A=30-60 CrCl (mL/Min)

Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

Group B=CrCL<30 mL/Min Not on Dialysis

Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

Group C=CrCL<30 mL/Min and on Dialysis

Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.

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
Group A=30-60 CrCl (mL/Min)	12
Group B=CrCL<30 mL/Min Not on Dialysis	6
Group C=CrCL<30 mL/Min and on Dialysis	1

Reported measurements

Source class 1

Values in Months · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Group A=30-60 CrCl (mL/Min)	21.8	Not reported	14.4	34.8	Not reported
Group B=CrCL<30 mL/Min Not on Dialysis	8.4	Not reported	7.9	9.4	Not reported
Group C=CrCL<30 mL/Min and on Dialysis	25.4	Not reported	25.4	25.4	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
14.4
upper Limit
34.8
value
21.8
group Id
OG001
lower Limit
7.9
upper Limit
9.4
value
8.4
group Id
OG002
lower Limit
25.4
upper Limit
25.4
value
25.4

denoms

counts
group Id
OG000
value
12
group Id
OG001
value
6
group Id
OG002
value
1
units
Participants

description

dispersion Type

Inter-Quartile Range

groups

description
Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
id
OG000
title
Group A=30-60 CrCl (mL/Min)
description
Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
id
OG001
title
Group B=CrCL<30 mL/Min Not on Dialysis
description
Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
id
OG002
title
Group C=CrCL<30 mL/Min and on Dialysis

param Type

MEDIAN

population Description

Patients treated at the recommended phase II dose who experienced a response to treatment

reporting Status

POSTED

time Frame

56 months

title

Duration of Response

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice