NCT01109004 · ADVERSE EVENTS

Adverse events

Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702) · Source last updated 2021-12-09

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: 1%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tandem Auto Transplant Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.	42 / 247	0 / 247	Not reported / Not reported
RVD Consolidation Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.	45 / 254	0 / 254	Not reported / Not reported
Lenalidomide Maintenance Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.	53 / 257	0 / 257	Not reported / Not reported

Group identifiers: EG000: Tandem Auto Transplant · EG001: RVD Consolidation · EG002: Lenalidomide Maintenance

Serious adverse events

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

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Haemolytic anaemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Splenic infarction
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Acute myocardial infarction
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Atrial fibrillation
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Bradycardia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
247
num Events
1
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Cardiac failure congestive
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Cardiac tamponade
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
247
num Events
1
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Cardiac valve disease
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
247
num Events
1
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Cardio-respiratory arrest
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Left ventricular failure
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
247
num Events
2
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Myocardial infarction
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Sinus bradycardia

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

description
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
id
EG000
other Num Affected
0
other Num At Risk
247
serious Num Affected
42
serious Num At Risk
247
title
Tandem Auto Transplant
description
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
id
EG001
other Num Affected
0
other Num At Risk
254
serious Num Affected
45
serious Num At Risk
254
title
RVD Consolidation
description
Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
id
EG002
other Num Affected
0
other Num At Risk
257
serious Num Affected
53
serious Num At Risk
257
title
Lenalidomide Maintenance

frequency Threshold

serious Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Haemolytic anaemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Splenic infarction
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Acute myocardial infarction
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Atrial fibrillation
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Bradycardia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
247
num Events
1
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Cardiac failure congestive
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Cardiac tamponade
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
247
num Events
1
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Cardiac valve disease
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
247
num Events
1
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Cardio-respiratory arrest
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
0
num At Risk
254
num Events
0
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Left ventricular failure
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
247
num Events
2
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
1
num At Risk
257
num Events
1
term
Myocardial infarction
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
247
num Events
0
group Id
EG001
num Affected
1
num At Risk
254
num Events
1
group Id
EG002
num Affected
0
num At Risk
257
num Events
0
term
Sinus bradycardia

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Preserved source evidence · Not medical advice