NCT01438177 · OUTCOME

Number of Participants With Adverse Events of Grade 3 or Higher

Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma · Source last updated 2020-02-24

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: Treatment period plus 30 days post-treatment

What was measured

Adverse events reported here were at least possibly related to the protocol therapy.

Analysis population: Any patients who started the treatment

Groups in this outcome

Velcade+Cyclophosphamide+Chloroquine

VELCADE given by intravenous push at 1.3 mg/m\^2 on days 1, 4, 8, 11, 22, 25, 29 and 32. Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35. Chloroquine given at 500 mg orally daily on days 1-14 and 22-35. Each cycle is 42 days in length.

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
Velcade+Cyclophosphamide+Chloroquine	9

Reported measurements

Fatigue

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Velcade+Cyclophosphamide+Chloroquine	2	Not reported	Not reported	Not reported	Not reported

Hemoglobin

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Velcade+Cyclophosphamide+Chloroquine	1	Not reported	Not reported	Not reported	Not reported

Nasal cavity/paranasal reactions

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Velcade+Cyclophosphamide+Chloroquine	1	Not reported	Not reported	Not reported	Not reported

ANC/AGC

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Velcade+Cyclophosphamide+Chloroquine	4	Not reported	Not reported	Not reported	Not reported

Pain: pleural

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Velcade+Cyclophosphamide+Chloroquine	1	Not reported	Not reported	Not reported	Not reported

Platelets

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Velcade+Cyclophosphamide+Chloroquine	5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
title
Fatigue
categories
measurements
group Id
OG000
value
1
title
Hemoglobin
categories
measurements
group Id
OG000
value
1
title
Nasal cavity/paranasal reactions
categories
measurements
group Id
OG000
value
4
title
ANC/AGC
categories
measurements
group Id
OG000
value
1
title
Pain: pleural
categories
measurements
group Id
OG000
value
5
title
Platelets

denoms

counts
group Id
OG000
value
9
units
Participants

description

Adverse events reported here were at least possibly related to the protocol therapy.

groups

description
VELCADE given by intravenous push at 1.3 mg/m\^2 on days 1, 4, 8, 11, 22, 25, 29 and 32. Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35. Chloroquine given at 500 mg orally daily on days 1-14 and 22-35. Each cycle is 42 days in length.
id
OG000
title
Velcade+Cyclophosphamide+Chloroquine

param Type

NUMBER

population Description

Any patients who started the treatment

reporting Status

POSTED

time Frame

Treatment period plus 30 days post-treatment

title

Number of Participants With Adverse Events of Grade 3 or Higher

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice