NCT00602641 · ADVERSE EVENTS

Adverse events

Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2026-08-28

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: Assessed every 28 days while on treatment and for 30 days after the end of treatment
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
MPT-T Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.	110 / 148	29 / 148	Not reported / Not reported
mPR-R Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.	88 / 150	34 / 151	Not reported / Not reported

Group identifiers: EG000: MPT-T · EG001: mPR-R

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
Immune system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
148
group Id
EG001
num Affected
1
num At Risk
150
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
16
num At Risk
148
group Id
EG001
num Affected
11
num At Risk
150
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
148
group Id
EG001
num Affected
1
num At Risk
150
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
29
num At Risk
148
group Id
EG001
num Affected
17
num At Risk
150
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
21
num At Risk
148
group Id
EG001
num Affected
10
num At Risk
150
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
148
group Id
EG001
num Affected
0
num At Risk
150
term
Myelodysplastic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
41
num At Risk
148
group Id
EG001
num Affected
43
num At Risk
150
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
18
num At Risk
148
group Id
EG001
num Affected
14
num At Risk
150
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
148
group Id
EG001
num Affected
0
num At Risk
150
term
Asystole
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
148
group Id
EG001
num Affected
2
num At Risk
150
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
148
group Id
EG001
num Affected
0
num At Risk
150
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
148
group Id
EG001
num Affected
3
num At Risk
150
term
Myocardial infarction

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
11
num At Risk
148
group Id
EG001
num Affected
22
num At Risk
151
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
12
num At Risk
148
group Id
EG001
num Affected
17
num At Risk
151
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
9
num At Risk
151
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
8
num At Risk
148
group Id
EG001
num Affected
12
num At Risk
151
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
17
num At Risk
151
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
14
num At Risk
148
group Id
EG001
num Affected
15
num At Risk
151
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
9
num At Risk
151
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
8
num At Risk
148
group Id
EG001
num Affected
2
num At Risk
151
term
Peripheral sensory neuropathy

Complete source fields

event Groups

description
Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.
id
EG000
other Num Affected
29
other Num At Risk
148
serious Num Affected
110
serious Num At Risk
148
title
MPT-T
description
Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
id
EG001
other Num Affected
34
other Num At Risk
151
serious Num Affected
88
serious Num At Risk
150
title
mPR-R

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
11
num At Risk
148
group Id
EG001
num Affected
22
num At Risk
151
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
12
num At Risk
148
group Id
EG001
num Affected
17
num At Risk
151
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
9
num At Risk
151
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
8
num At Risk
148
group Id
EG001
num Affected
12
num At Risk
151
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
17
num At Risk
151
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
14
num At Risk
148
group Id
EG001
num Affected
15
num At Risk
151
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
10
num At Risk
148
group Id
EG001
num Affected
9
num At Risk
151
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
8
num At Risk
148
group Id
EG001
num Affected
2
num At Risk
151
term
Peripheral sensory neuropathy

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
148
group Id
EG001
num Affected
1
num At Risk
150
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
16
num At Risk
148
group Id
EG001
num Affected
11
num At Risk
150
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
148
group Id
EG001
num Affected
1
num At Risk
150
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
29
num At Risk
148
group Id
EG001
num Affected
17
num At Risk
150
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
21
num At Risk
148
group Id
EG001
num Affected
10
num At Risk
150
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
148
group Id
EG001
num Affected
0
num At Risk
150
term
Myelodysplastic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
41
num At Risk
148
group Id
EG001
num Affected
43
num At Risk
150
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
18
num At Risk
148
group Id
EG001
num Affected
14
num At Risk
150
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
148
group Id
EG001
num Affected
0
num At Risk
150
term
Asystole
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
148
group Id
EG001
num Affected
2
num At Risk
150
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
148
group Id
EG001
num Affected
0
num At Risk
150
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
148
group Id
EG001
num Affected
3
num At Risk
150
term
Myocardial infarction

time Frame

Assessed every 28 days while on treatment and for 30 days after the end of treatment

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Preserved source evidence · Not medical advice