NCT00807599 · ADVERSE EVENTS

Adverse events

Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L · Source last updated 2019-03-15

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 4 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Continue Lenalidomide and Dexamethasone All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection * continue lenalidomide and dexamethasone * saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.	17 / 26	26 / 26	3 / 26
Stem Cell Transplant x 1 or x 2 All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : * stem cell transplant right after collection * continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.	18 / 24	24 / 24	5 / 24

Group identifiers: EG000: Continue Lenalidomide and Dexamethasone · EG001: Stem Cell Transplant x 1 or x 2

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
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Back Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Blood Glucose Increase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
0
num At Risk
24
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Cardiac Valve Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
0
num At Risk
24
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
0
num At Risk
24
term
Decubitus ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
26
group Id
EG001
num Affected
4
num At Risk
24
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
2
num At Risk
24
term
Hemoglobin decreased

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
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
9
num At Risk
24
term
ALT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
5
num At Risk
24
term
AST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
3
num At Risk
24
term
Alkaline Phosphatase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
3
num At Risk
24
term
Bilirubin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
CPK
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
2
num At Risk
24
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
4
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
4
num At Risk
24
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
group Id
EG001
num Affected
0
num At Risk
24
term
Edema: limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
9
num At Risk
26
group Id
EG001
num Affected
10
num At Risk
24
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
17
num At Risk
26
group Id
EG001
num Affected
13
num At Risk
24
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Hypoglycemia

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
26
description
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection * continue lenalidomide and dexamethasone * saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
id
EG000
other Num Affected
26
other Num At Risk
26
serious Num Affected
17
serious Num At Risk
26
title
Continue Lenalidomide and Dexamethasone
deaths Num Affected
5
deaths Num At Risk
24
description
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : * stem cell transplant right after collection * continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
id
EG001
other Num Affected
24
other Num At Risk
24
serious Num Affected
18
serious Num At Risk
24
title
Stem Cell Transplant x 1 or x 2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
9
num At Risk
24
term
ALT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
5
num At Risk
24
term
AST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
3
num At Risk
24
term
Alkaline Phosphatase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
3
num At Risk
24
term
Bilirubin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
CPK
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
2
num At Risk
24
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
4
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
26
group Id
EG001
num Affected
4
num At Risk
24
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
group Id
EG001
num Affected
0
num At Risk
24
term
Edema: limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
9
num At Risk
26
group Id
EG001
num Affected
10
num At Risk
24
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
17
num At Risk
26
group Id
EG001
num Affected
13
num At Risk
24
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Hypoglycemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Back Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Blood Glucose Increase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
0
num At Risk
24
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Cardiac Valve Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
1
num At Risk
24
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
0
num At Risk
24
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
0
num At Risk
24
term
Decubitus ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
26
group Id
EG001
num Affected
4
num At Risk
24
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
26
group Id
EG001
num Affected
2
num At Risk
24
term
Hemoglobin decreased

time Frame

Up to 4 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice