NCT02003625 · ADVERSE EVENTS

Adverse events

Meloxicam vs Placebo for Mobilization · Source last updated 2020-05-18

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to 30 days after the last apheresis session (up to 36 days after the start of treatment or 42 days for multiple myeloma patients that received cyclophosphamide)
Other-event reporting threshold: 0%

Only grade 3+ toxicities were recorded for the study

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
A. GCSF + Placebo GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo	0 / 15	0 / 15	0 / 15
B. GCSF + Meloxicam B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam	0 / 15	0 / 15	0 / 15

Group identifiers: EG000: A. GCSF + Placebo · EG001: B. GCSF + Meloxicam

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

description

Only grade 3+ toxicities were recorded for the study

event Groups

deaths Num Affected
0
deaths Num At Risk
15
description
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo
id
EG000
other Num Affected
0
other Num At Risk
15
serious Num Affected
0
serious Num At Risk
15
title
A. GCSF + Placebo
deaths Num Affected
0
deaths Num At Risk
15
description
B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam
id
EG001
other Num Affected
0
other Num At Risk
15
serious Num Affected
0
serious Num At Risk
15
title
B. GCSF + Meloxicam

frequency Threshold

time Frame

Up to 30 days after the last apheresis session (up to 36 days after the start of treatment or 42 days for multiple myeloma patients that received cyclophosphamide)

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Preserved source evidence · Not medical advice