Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
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.
Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Duration of treatment and follow up until death or 6 years post registration, whichever occurs first.
What was measured
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Analysis population: Participants who received at least one dose of protocol treatment.
Groups in this outcome
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
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
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
52
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
48
Reported measurements
Abdominal pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Acute kidney injury
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Agitation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
2
Not reported
Not reported
Not reported
Not reported
Alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Allergic reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Anemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
8
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
6
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
2
Not reported
Not reported
Not reported
Not reported
Atrial fibrillation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
3
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Back pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Bone pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
2
Not reported
Not reported
Not reported
Not reported
Cataract
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Creatinine increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
5
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Dizziness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Dry skin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
2
Not reported
Not reported
Not reported
Not reported
Edema limbs
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Encephalopathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Eye disorders - Other, specify
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Fall
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
6
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
5
Not reported
Not reported
Not reported
Not reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Fracture
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Gait disturbance
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Gastrointestinal disorders - Other, specify
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Generalized muscle weakness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
4
Not reported
Not reported
Not reported
Not reported
Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
4
Not reported
Not reported
Not reported
Not reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
3
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
4
Not reported
Not reported
Not reported
Not reported
Hypoxia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
INR increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Infections and infestations - Other, specify
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
3
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
4
Not reported
Not reported
Not reported
Not reported
Infusion related reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
3
Not reported
Not reported
Not reported
Not reported
Insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
2
Not reported
Not reported
Not reported
Not reported
Lung infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
3
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
5
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
14
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
13
Not reported
Not reported
Not reported
Not reported
Multi-organ failure
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Muscle weakness lower limb
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Muscle weakness trunk
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Musculoskeletal and connective tiss disorder - Other
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Neck pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Neuralgia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
8
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
5
Not reported
Not reported
Not reported
Not reported
Osteonecrosis of jaw
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Pain in extremity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Peripheral motor neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
4
Not reported
Not reported
Not reported
Not reported
Peripheral sensory neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
4
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
6
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
10
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
10
Not reported
Not reported
Not reported
Not reported
Pneumonitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Portal vein thrombosis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Pulmonary edema
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Rash acneiform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Rash maculo-papular
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
3
Not reported
Not reported
Not reported
Not reported
Resp, thoracic and mediastinal disorders - Other
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Respiratory failure
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Sepsis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Skin infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Stroke
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Supraventricular tachycardia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Syncope
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
2
Not reported
Not reported
Not reported
Not reported
Thromboembolic event
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
4
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Tremor
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Urinary tract infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Urine output decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
0
Not reported
Not reported
Not reported
Not reported
Weight loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
1
Not reported
Not reported
Not reported
Not reported
White blood cell decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
4
Not reported
Not reported
Not reported
Not reported
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
5
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Abdominal pain
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Acute kidney injury
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Agitation
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Alkaline phosphatase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Allergic reaction
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
6
title
Anemia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
title
Atrial fibrillation
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Back pain
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Blood bilirubin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Bone pain
denoms
counts
group Id
OG000
value
52
group Id
OG001
value
48
units
Participants
description
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
groups
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
OG000
title
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
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
OG001
title
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
param Type
NUMBER
population Description
Participants who received at least one dose of protocol treatment.
reporting Status
POSTED
time Frame
Duration of treatment and follow up until death or 6 years post registration, whichever occurs first.
title
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Triangle