NCT00217438 · ADVERSE EVENTS

Adverse events

Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma · Source last updated 2015-08-21

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: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant) INDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.	0 / 66	14 / 66	Not reported / Not reported
Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant) INDUCTION THERAPY: Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.	0 / 64	7 / 64	Not reported / Not reported

Group identifiers: EG000: Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant) · EG001: Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)

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.

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
66
num Events
7
group Id
EG001
num Affected
3
num At Risk
64
num Events
3
term
Mucositis-Grade 3 or higher
notes
Mucositis recorded separately.
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
66
num Events
7
group Id
EG001
num Affected
3
num At Risk
64
num Events
3
term
Diarrhea
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
66
num Events
0
group Id
EG001
num Affected
1
num At Risk
64
num Events
1
term
Atrial fibrillation
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
66
num Events
1
group Id
EG001
num Affected
0
num At Risk
64
num Events
0
term
Pulmonary embolism
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
66
num Events
1
group Id
EG001
num Affected
0
num At Risk
64
num Events
0
term
Neutropenic fever
notes
Mucositis recorded separately
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
66
num Events
7
group Id
EG001
num Affected
2
num At Risk
64
num Events
2
term
Nausea/Vomiting
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
66
num Events
0
group Id
EG001
num Affected
1
num At Risk
64
num Events
1
term
Dehydration
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
66
num Events
1
group Id
EG001
num Affected
0
num At Risk
64
num Events
0
term
Anorexia
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
66
num Events
1
group Id
EG001
num Affected
0
num At Risk
64
num Events
0
term
Graft versus host disease of the gut

Complete source fields

event Groups

description
INDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
id
EG000
other Num Affected
14
other Num At Risk
66
serious Num Affected
0
serious Num At Risk
66
title
Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)
description
INDUCTION THERAPY: Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
id
EG001
other Num Affected
7
other Num At Risk
64
serious Num Affected
0
serious Num At Risk
64
title
Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)

frequency Threshold

other Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
66
num Events
7
group Id
EG001
num Affected
3
num At Risk
64
num Events
3
term
Mucositis-Grade 3 or higher
notes
Mucositis recorded separately.
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
66
num Events
7
group Id
EG001
num Affected
3
num At Risk
64
num Events
3
term
Diarrhea
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
66
num Events
0
group Id
EG001
num Affected
1
num At Risk
64
num Events
1
term
Atrial fibrillation
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
66
num Events
1
group Id
EG001
num Affected
0
num At Risk
64
num Events
0
term
Pulmonary embolism
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
66
num Events
1
group Id
EG001
num Affected
0
num At Risk
64
num Events
0
term
Neutropenic fever
notes
Mucositis recorded separately
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
66
num Events
7
group Id
EG001
num Affected
2
num At Risk
64
num Events
2
term
Nausea/Vomiting
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
66
num Events
0
group Id
EG001
num Affected
1
num At Risk
64
num Events
1
term
Dehydration
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
66
num Events
1
group Id
EG001
num Affected
0
num At Risk
64
num Events
0
term
Anorexia
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
66
num Events
1
group Id
EG001
num Affected
0
num At Risk
64
num Events
0
term
Graft versus host disease of the gut

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Preserved source evidence · Not medical advice