NCT00617591 · OUTCOME

Occurrence of Induction Toxicities

Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM) · Source last updated 2014-01-17

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: Not reported
Time frame: 24 Months

What was measured

Tolerability of full dose Revlimid® with full dose Doxil® in combination with reduced schedule dexamethasone was to be assessed during Cycle 1 and at the start of Cycle 2 using, whenever possible, the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0. Due to increased neutropenia and fatigue, toxicities were reviewed after the first 29 participants were enrolled.

Analysis population: First 29 participants with the PLD starting dose of PLD 40 mg/m\^2, due to increased neutropenia and fatigue.

Groups in this outcome

Induction at Initial Full Dose

Induction Phase for First 29 Participants Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1.

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
Induction at Initial Full Dose	29

Reported measurements

Percentage with Dose Reductions Required

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction at Initial Full Dose	24	Not reported	Not reported	Not reported	Not reported

Percentage Receiving < 4 Cycles of Therapy

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction at Initial Full Dose	20	Not reported	Not reported	Not reported	Not reported

Percentage Who Discontinued After Only 1 Cycle

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction at Initial Full Dose	13.79	Not reported	Not reported	Not reported	Not reported

Percentage with Grade 3/4 Neutropenia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction at Initial Full Dose	48	Not reported	Not reported	Not reported	Not reported

Percentage with Grade 3/4 Fatigue

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction at Initial Full Dose	20	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
24
title
Percentage with Dose Reductions Required
categories
measurements
group Id
OG000
value
20
title
Percentage Receiving < 4 Cycles of Therapy
categories
measurements
group Id
OG000
value
13.79
title
Percentage Who Discontinued After Only 1 Cycle
categories
measurements
group Id
OG000
value
48
title
Percentage with Grade 3/4 Neutropenia
categories
measurements
group Id
OG000
value
20
title
Percentage with Grade 3/4 Fatigue

denoms

counts
group Id
OG000
value
29
units
Participants

description

groups

description
Induction Phase for First 29 Participants Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1.
id
OG000
title
Induction at Initial Full Dose

param Type

NUMBER

population Description

First 29 participants with the PLD starting dose of PLD 40 mg/m\^2, due to increased neutropenia and fatigue.

reporting Status

POSTED

time Frame

24 Months

title

Occurrence of Induction Toxicities

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice