NCT00006244 · ADVERSE EVENTS

Adverse events

Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma · Source last updated 2017-07-12

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Immunotherapy Treatment Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion	10 / 36	0 / 36	27 / 36

Group identifiers: EG000: Immunotherapy Treatment

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
Transplant related
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Delayed ANC Engraftment
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
36
term
Neutropenic fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Fever and GI
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related One patient also had diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
one patient transplant related one patient interferon related
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
term
cardiac event
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Interferon related
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
sarcoidosis/failure to thrive
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
colitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
36
term
fever

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

event Groups

deaths Num Affected
27
deaths Num At Risk
36
description
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
id
EG000
other Num Affected
0
other Num At Risk
36
serious Num Affected
10
serious Num At Risk
36
title
Immunotherapy Treatment

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Delayed ANC Engraftment
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
36
term
Neutropenic fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
Fever and GI
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related One patient also had diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
one patient transplant related one patient interferon related
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
term
cardiac event
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Interferon related
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
sarcoidosis/failure to thrive
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
term
colitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transplant related
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
36
term
fever

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Preserved source evidence · Not medical advice