NCT01668719 · ADVERSE EVENTS

Adverse events

S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma · Source last updated 2026-04-28

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: Duration of treatment and follow up until death or 6 years post registration, whichever occurs first.
Other-event reporting threshold: 0%

6 participants in Phase I and 100 participants in Phase II were evaluable and assessed for AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenali INDUCTION: Participants receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	3 / 6	6 / 6	2 / 6
Arm I (Bortezomib, Lenalidomide, Dexamethasone) INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Lenalidomide: Given PO	6 / 52	52 / 52	19 / 52
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Elotuzumab: Given IV Lenalidomide: Given PO	24 / 48	47 / 48	16 / 48

Group identifiers: EG000: Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenali · EG001: Arm I (Bortezomib, Lenalidomide, Dexamethasone) · EG002: Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)

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
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
4
num At Risk
48
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
3
num At Risk
48
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
2
num At Risk
48
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Flu like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
2
num At Risk
48
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Malaise

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
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
39
num At Risk
52
group Id
EG002
num Affected
21
num At Risk
48
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Blood and lymphatic system disorders - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Cardiac disorders-Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Paroxysmal atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
52
group Id
EG002
num Affected
3
num At Risk
48
term
Sinus bradycardia

Complete source fields

description

6 participants in Phase I and 100 participants in Phase II were evaluable and assessed for AEs.

event Groups

deaths Num Affected
2
deaths Num At Risk
6
description
INDUCTION: Participants receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenali
deaths Num Affected
19
deaths Num At Risk
52
description
INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Lenalidomide: Given PO
id
EG001
other Num Affected
52
other Num At Risk
52
serious Num Affected
6
serious Num At Risk
52
title
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
deaths Num Affected
16
deaths Num At Risk
48
description
INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Elotuzumab: Given IV Lenalidomide: Given PO
id
EG002
other Num Affected
47
other Num At Risk
48
serious Num Affected
24
serious Num At Risk
48
title
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
39
num At Risk
52
group Id
EG002
num Affected
21
num At Risk
48
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Blood and lymphatic system disorders - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Cardiac disorders-Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
0
num At Risk
48
term
Paroxysmal atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
52
group Id
EG002
num Affected
3
num At Risk
48
term
Sinus bradycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
4
num At Risk
48
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
3
num At Risk
48
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
2
num At Risk
48
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Flu like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
2
num At Risk
48
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
52
group Id
EG002
num Affected
1
num At Risk
48
term
Malaise

time Frame

Duration of treatment and follow up until death or 6 years post registration, whichever occurs first.

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

Preserved source evidence · Not medical advice