Trial Outcomes & Findings for Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM) (NCT NCT01782963)
NCT ID: NCT01782963
Last Updated: 2018-10-31
Results Overview
Participants are considered to have achieved an objective response if they meet the International Myeloma Working Group uniform response criteria for any of the following: * Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) * CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BM * VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours * PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
2 years
Results posted on
2018-10-31
Participant Flow
Participant milestones
| Measure |
Treatment Arm
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=50 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
|
ISS Stage at Diagnosis
I
|
19 Participants
n=5 Participants
|
|
ISS Stage at Diagnosis
II
|
17 Participants
n=5 Participants
|
|
ISS Stage at Diagnosis
III
|
14 Participants
n=5 Participants
|
|
Durie-Salmon Stage
I
|
16 Participants
n=5 Participants
|
|
Durie-Salmon Stage
II
|
16 Participants
n=5 Participants
|
|
Durie-Salmon Stage
III
|
18 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
25 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
18 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
7 Participants
n=5 Participants
|
|
ECOG Performance Status
3
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
4
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
5
|
0 Participants
n=5 Participants
|
|
High-Risk Cytogenetics
Yes
|
6 Participants
n=5 Participants
|
|
High-Risk Cytogenetics
No
|
42 Participants
n=5 Participants
|
|
High-Risk Cytogenetics
Unknown
|
2 Participants
n=5 Participants
|
|
Serum Heavy/Light Chain
IgG
|
34 Participants
n=5 Participants
|
|
Serum Heavy/Light Chain
IgA
|
9 Participants
n=5 Participants
|
|
Serum Heavy/Light Chain
Light-chain only
|
5 Participants
n=5 Participants
|
|
Serum Heavy/Light Chain
Unknown
|
2 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28 Kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsParticipants are considered to have achieved an objective response if they meet the International Myeloma Working Group uniform response criteria for any of the following: * Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) * CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BM * VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours * PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required
Outcome measures
| Measure |
Treatment Arm
n=50 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
Low Risk Cytogenetics
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|---|
|
Objective Response Rate
Complete Response (CR)
|
16 Participants
|
—
|
|
Objective Response Rate
Stringent Complete Response
|
6 Participants
|
—
|
|
Objective Response Rate
Very Good Partial Response (VGPR)
|
11 Participants
|
—
|
|
Objective Response Rate
Partial Response (PR)
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsA summary of the number of participants with grade 3 or higher treatment related adverse events for adverse events that had an overall incidence of greater than 15% (any grade) as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4).
Outcome measures
| Measure |
Treatment Arm
n=50 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
Low Risk Cytogenetics
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Fatigue
|
8 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Peripheral Neuropathy
|
1 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Peripheral Edema
|
1 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Insomnia
|
1 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Anemia
|
1 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Thrombocytopenia
|
1 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Constipation
|
0 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Dysgeusia
|
0 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Hyperglycemia
|
2 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Nausea
|
0 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Psychiatric Disorder, other
|
2 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Generalized Muscle Weakness
|
2 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Hypophosphatemia
|
17 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Neutropenia
|
7 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Diarrhea
|
0 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Rash
|
5 Participants
|
—
|
|
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Depression
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From the start of treatment until death or progression or until 3 years after the last participant is enrolledThe median amount of time as measured from the start of treatment until either death or progression. Progressive disease requires 1 or more of the following: * \>=25% increase from lowest response level in serum M-protein (\>=0.5 g/dL absolute increase) and/or urine M-component (\>=200 mg/24hr absolute increase) * \>=25% increase in the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL). Only for use in patients without measurable serum and M-protein levels. * \>=25% increase in bone marrow plasma cell percentage (absolute percentage \>=10%) * New or increase in existing bone lesions or soft tissue plasmacytomas * Hypercalcemia (serum calcium \>11.5 mg/dL) due solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
Treatment Arm
n=50 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
Low Risk Cytogenetics
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|---|
|
Median Progression Free Survival
|
35.1 Months
Interval 30.9 to
Upper bound is infinity due to skew of survival data
|
—
|
SECONDARY outcome
Timeframe: From the start of treatment until death or until 5 years after the time of disease progressionPopulation: Median overall survival was not met before the end of follow-up/ data cutoff point because more than half of the participants were still alive.
The median overall survival as measured from the start of treatment until the time of death due to any cause.
Outcome measures
| Measure |
Treatment Arm
n=50 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
Low Risk Cytogenetics
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|---|
|
Median Overall Survival
|
NA years
Median overall survival was not met before the data cutoff point because more than half of the participants were still alive
|
—
|
SECONDARY outcome
Timeframe: From the start of treatment until the time of first documented response, median duration of 1.1 monthsPopulation: Participants that achieved a response
Median amount of time from the start of treatment until first documented response as defined by the International Myeloma Working Group uniform response criteria Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BM VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required
Outcome measures
| Measure |
Treatment Arm
n=43 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
Low Risk Cytogenetics
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|---|
|
Median Time to Response
|
1.1 Months
Interval 1.1 to 1.3
|
—
|
SECONDARY outcome
Timeframe: 2 yearsResponse rate was assessed using the International Myeloma Working Group uniform response criteria. Stringent complete response, Complete Response, Very Good Partial Response, and Partial Response are defined in outcome measure 1. * MR included participants in whom some, but not all, criteria for PR were fulfilled, providing the remaining criteria satisfied the requirements for MR. Required all of the following: * ≥25% to ≤ 49% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart. * If present, a 50 to 89% reduction in 24-hour light chain excretion, which still exceeds 200 mg/24 h, for at least two determinations six weeks apart. * 25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for at least six weeks. * No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response). * Stable Disease: Not meeting the criteria for minimal response or
Outcome measures
| Measure |
Treatment Arm
n=6 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
Low Risk Cytogenetics
n=44 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|---|
|
Response Rate With Respect to Cytogenetic Characteristics
Stringent Complete Response
|
0 Participants
|
6 Participants
|
|
Response Rate With Respect to Cytogenetic Characteristics
Complete Response
|
2 Participants
|
14 Participants
|
|
Response Rate With Respect to Cytogenetic Characteristics
Minimal Response
|
1 Participants
|
0 Participants
|
|
Response Rate With Respect to Cytogenetic Characteristics
Stable Disease
|
0 Participants
|
3 Participants
|
|
Response Rate With Respect to Cytogenetic Characteristics
Not evaluable
|
0 Participants
|
3 Participants
|
|
Response Rate With Respect to Cytogenetic Characteristics
Very Good Partial Response
|
2 Participants
|
9 Participants
|
|
Response Rate With Respect to Cytogenetic Characteristics
Partial Response
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dosePopulation: A total of only 10 participants per arm were evaluated for drug plasma concentrations following Bortezomib administration.The number of participants vary by time-point due to missing measurements for the concentrations.
The pharmacokinetic profile of intravenous and subcutaneous bortezomib administration in combination with lenalidomide and dexamethasone.
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
Low Risk Cytogenetics
n=10 Participants
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|---|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Day 22, 30 min post-dose
|
14.9 ng/mL
Standard Deviation 4.3
|
21.69 ng/mL
Standard Deviation 10.1
|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Day 22, 5 hours post-dose
|
2.85 ng/mL
Standard Deviation 1.05
|
4.16 ng/mL
Standard Deviation 2.07
|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Cycle 2 Day 1, pre-dose
|
0.53 ng/mL
Standard Deviation 0.15
|
0.49 ng/mL
Standard Deviation 0.14
|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Day 1, 5 minutes (min) post dose
|
98.84 ng/mL
Standard Deviation 39.27
|
13 ng/mL
Standard Deviation 15.79
|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Day 1, 30 min post dose
|
8.73 ng/mL
Standard Deviation 5.59
|
20.5 ng/mL
Standard Deviation 10.91
|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Day 1, 5 hours post dose
|
1.82 ng/mL
Standard Deviation 1.31
|
1.96 ng/mL
Standard Deviation 0.56
|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Day 8 pre-dose
|
0.44 ng/mL
Standard Deviation 0.15
|
0.33 ng/mL
Standard Deviation 0.09
|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Day 15 pre-dose
|
0.66 ng/mL
Standard Deviation 0.22
|
0.49 ng/mL
Standard Deviation 0.12
|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Day 22 pre-dose
|
0.83 ng/mL
Standard Deviation 0.34
|
0.66 ng/mL
Standard Deviation 0.18
|
|
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Day 22, 5 min post-dose
|
114.3 ng/mL
Standard Deviation 76.6
|
10.29 ng/mL
Standard Deviation 13.24
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: No pharmacogenomic markers were evaluated for relation to neuropathy
To evaluate pharmacogenomic markers among patients with treatment related polyneuropathy.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Arm
Serious events: 34 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm
n=50 participants at risk
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Endocrine disorders
Adrenal insufficiency
|
4.0%
2/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Eye disorders
Corneal ulcer
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Creatinine increased
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
2/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
General disorders
Edema limbs
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Eye disorders
Eye disorders - Other, Sclera redness
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
General disorders
Fatigue
|
16.0%
8/50 • Number of events 9 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Gastroenteritis
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, GI Bleed
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.0%
2/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Cardiac disorders
Heart failure
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
2/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Vascular disorders
Hypertension
|
4.0%
2/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
2/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
30.0%
15/50 • Number of events 20 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Nervous system disorders
Nervous system disorders - Other, Altered mental status and loss of consciousness
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Neutrophil count decreased
|
4.0%
2/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Platelet count decreased
|
4.0%
2/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
2/50 • Number of events 2 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Infections and infestations
Upper respiratory infection
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
White blood cell decreased
|
2.0%
1/50 • Number of events 1 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
Other adverse events
| Measure |
Treatment Arm
n=50 participants at risk
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
4/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
5/50 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Psychiatric disorders
Agitation
|
10.0%
5/50 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
5/50 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
5/50 • Number of events 14 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
30/50 • Number of events 62 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Anorexia
|
24.0%
12/50 • Number of events 17 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Psychiatric disorders
Anxiety
|
16.0%
8/50 • Number of events 10 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
3/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.0%
3/50 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Aspartate aminotransferase increased
|
14.0%
7/50 • Number of events 9 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Cardiac disorders
Atrial fibrillation
|
6.0%
3/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
20/50 • Number of events 30 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Blood bilirubin increased
|
6.0%
3/50 • Number of events 14 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Eye disorders
Blurred vision
|
6.0%
3/50 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.0%
6/50 • Number of events 8 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
8.0%
4/50 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Psychiatric disorders
Confusion
|
8.0%
4/50 • Number of events 5 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Constipation
|
44.0%
22/50 • Number of events 30 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
5/50 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Creatinine increased
|
8.0%
4/50 • Number of events 16 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
4/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Psychiatric disorders
Depression
|
22.0%
11/50 • Number of events 12 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
25/50 • Number of events 37 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Nervous system disorders
Dizziness
|
20.0%
10/50 • Number of events 11 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Dry mouth
|
12.0%
6/50 • Number of events 7 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.0%
6/50 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Nervous system disorders
Dysgeusia
|
26.0%
13/50 • Number of events 17 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.0%
11/50 • Number of events 22 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
General disorders
Edema face
|
8.0%
4/50 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
General disorders
Edema limbs
|
46.0%
23/50 • Number of events 37 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
General disorders
Fatigue
|
82.0%
41/50 • Number of events 92 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
General disorders
Fever
|
10.0%
5/50 • Number of events 5 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
General disorders
Flu like symptoms
|
6.0%
3/50 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.0%
4/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
10/50 • Number of events 11 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Nervous system disorders
Headache
|
12.0%
6/50 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.0%
4/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Vascular disorders
Hot flashes
|
6.0%
3/50 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.0%
3/50 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
20/50 • Number of events 33 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.0%
4/50 • Number of events 5 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Vascular disorders
Hypertension
|
40.0%
20/50 • Number of events 72 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
5/50 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
10/50 • Number of events 20 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
10/50 • Number of events 13 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.0%
7/50 • Number of events 13 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.0%
13/50 • Number of events 26 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
54.0%
27/50 • Number of events 68 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Vascular disorders
Hypotension
|
16.0%
8/50 • Number of events 11 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
INR increased
|
6.0%
3/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Psychiatric disorders
Insomnia
|
38.0%
19/50 • Number of events 23 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.0%
4/50 • Number of events 5 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
10/50 • Number of events 11 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Neutrophil count decreased
|
14.0%
7/50 • Number of events 23 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
General disorders
Non-cardiac chest pain
|
6.0%
3/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Oral pain
|
6.0%
3/50 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
General disorders
Pain
|
24.0%
12/50 • Number of events 23 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.0%
14/50 • Number of events 26 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.0%
4/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.0%
7/50 • Number of events 8 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
64.0%
32/50 • Number of events 59 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Platelet count decreased
|
32.0%
16/50 • Number of events 48 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
32.0%
16/50 • Number of events 35 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Infections and infestations
Rhinitis infective
|
6.0%
3/50 • Number of events 3 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Cardiac disorders
Sinus bradycardia
|
16.0%
8/50 • Number of events 21 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
8.0%
4/50 • Number of events 4 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Vascular disorders
Thromboembolic event
|
10.0%
5/50 • Number of events 6 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Infections and infestations
Upper respiratory infection
|
30.0%
15/50 • Number of events 22 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Infections and infestations
Urinary tract infection
|
14.0%
7/50 • Number of events 8 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
6/50 • Number of events 8 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
Weight loss
|
16.0%
8/50 • Number of events 8 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
|
|
Investigations
White blood cell decreased
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26.0%
13/50 • Number of events 48 • From the start of treatment until 30 days after the end of treatment (approximately 16 months)
Serious adverse events were defined as any grade 3 or greater adverse event that was deemed to be at least potentially related to one of the study drugs.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place