NCT02043847 · ADVERSE EVENTS

Adverse events

TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03) · Source last updated 2024-11-13

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: 1 year
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1Total Marrow Irradiation (TMI) 3Gy 3Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days. Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue	1 / 3	2 / 3	1 / 3
Cohort 2 Total Marrow Irradiation (TMI) 6Gy 6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue	1 / 3	2 / 3	1 / 3
Cohort 3 Total Marrow Irradiation (TMI) 9Gy 9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue	1 / 6	3 / 6	1 / 6

Group identifiers: EG000: Cohort 1Total Marrow Irradiation (TMI) 3Gy · EG001: Cohort 2 Total Marrow Irradiation (TMI) 6Gy · EG002: Cohort 3 Total Marrow Irradiation (TMI) 9Gy

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Metastatic prostate cancer(3GY) Progressive myeloma (6Gy and 9Gy)
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Death

Other reported adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Mucositis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Diarrhea

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
3
description
3Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days. Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
id
EG000
other Num Affected
2
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Cohort 1Total Marrow Irradiation (TMI) 3Gy
deaths Num Affected
1
deaths Num At Risk
3
description
6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
id
EG001
other Num Affected
2
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
deaths Num Affected
1
deaths Num At Risk
6
description
9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
id
EG002
other Num Affected
3
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Cohort 3 Total Marrow Irradiation (TMI) 9Gy

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Mucositis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Diarrhea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Metastatic prostate cancer(3GY) Progressive myeloma (6Gy and 9Gy)
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
term
Death

time Frame

1 year

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Preserved source evidence · Not medical advice