Trial Outcomes & Findings for Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients (NCT NCT01402284)
NCT ID: NCT01402284
Last Updated: 2021-03-02
Results Overview
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
4 years and 9 months and 2 days
Results posted on
2021-03-02
Participant Flow
Participant milestones
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone Therapy
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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|---|---|
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Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone Therapy
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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|---|---|
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Overall Study
Withdrawal consent
|
2
|
|
Overall Study
Follows up at Memorial Sloan Kettering
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Disease progression on study
|
10
|
Baseline Characteristics
Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients
Baseline characteristics by cohort
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 Participants
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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45 Participants
n=5 Participants
|
|
Isotypes
IgG kappa
|
51 percentage of participants
n=5 Participants
|
|
Isotypes
IgG lambda
|
16 percentage of participants
n=5 Participants
|
|
Isotypes
IgA kappa
|
9 percentage of participants
n=5 Participants
|
|
Isotypes
IgA lambda
|
9 percentage of participants
n=5 Participants
|
|
Isotypes
Free kappa
|
9 percentage of participants
n=5 Participants
|
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Isotypes
Free lambda
|
4 percentage of participants
n=5 Participants
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PRIMARY outcome
Timeframe: 4 years and 9 months and 2 daysHere is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 Participants
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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Number of Participants With Serious and Non-serious Adverse Events
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45 Participants
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SECONDARY outcome
Timeframe: 48.3 monthsResponse is assessed by the International Myeloma Working Group Criteria. Patients who attained a partial response or better (BoR) response by the end of induction. Partial response is ≥50% reduction of serum M-protein and reduction in 24h urinary M-protein.
Outcome measures
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 Participants
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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Overall Response Rate
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97.8 percentage of participants
Interval 88.2 to 99.9
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SECONDARY outcome
Timeframe: 48 monthsPFS is defined as time of start of treatment to time of progression or death, whichever occurs first. Response is assessed by the International Myeloma Working Group Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be \>10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 Participants
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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Progression Free Survival (PFS) at 48 Months
|
79.2 percentage of participants
Interval 63.8 to 88.6
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SECONDARY outcome
Timeframe: 48 monthsResponse is assessed by the International Myeloma Working Group Criteria. DOR is measured from the time measurement criteria are met for a partial response or better until first date that recurrent or progressive disease is objectively documented. Partial response is ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200mg per 24h. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be \>10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%.
Outcome measures
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 Participants
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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Percentage of Responders With Duration of Response (DOR) at 48 Months
|
81.1 percentage of participants
Interval 65.7 to 90.1
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SECONDARY outcome
Timeframe: up to 6 monthsOS is defined as the time of start of treatment to death from any cause.
Outcome measures
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 Participants
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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Overall Survival (OS) Rate
|
89.5 percentage of participants
Interval 63.6 to 97.3
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SECONDARY outcome
Timeframe: Cycle 1 Day 1, an average of 28 days ± 2 daysPopulation: Data were not collected due to lack of financial resources.
Cluster of differentiation 138+ (CD138)+ plasma cells purified from bone marrow aspirates to identify potential markers of early progression. Changes in selected genes were confirmed by quantitative polymerase chain reaction (PCR) if suggested to be related to risk of progression to multiple myeloma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 100Response is assessed by the International Myeloma Working Group Criteria. Complete response is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains. Immunophenotyping is performed by multi-parametric flow cytometry.
Outcome measures
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 Participants
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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Rate of Minimal Residual Disease (MRD) by Flow Cytometry
|
44.4 percentage of participants
Interval 29.6 to 60.0
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SECONDARY outcome
Timeframe: up to 2 yearsPopulation: \*Six patients withdrew from the study, four due to non-compliance and two to continue treatment at another institution. 'One patient refused to have a bone marrow biopsy procedure and one patient withdrew due to non-compliance. CR (n=0) after 8 cycles.
Response is assessed by the International Myeloma Working Group Criteria. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains (FLC). Complete response is negative immunofixation on serum, and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Stringent complete response (sCR) is normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. Near complete response (nCR) is the absence of myeloma protein on electrophoresis, independent of immunofixation status. Very good partial response (VGPR) is 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 \<100mg per 24h. Overall response rate (ORR) is patients who attained a partial response (PR) (≥50% reduction of serum M-protein and reduction in 24h urinary M-protein) or better (BoR) response.
Outcome measures
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 Participants
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
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Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
sCR/CR after 8 cycles
|
46.7 percentage of participants
Interval 31.7 to 62.1
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
MRDnegCR after 8 cycles
|
44.4 percentage of participants
Interval 29.6 to 60.0
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
nCR after 8 cycles
|
20 percentage of participants
Interval 9.6 to 34.6
|
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Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
≥VGPR after 8 cycles
|
89 percentage of participants
Interval 75.6 to 96.3
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
ORR after 8 cycles
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
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Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
sCR after 8 cycles
|
46.7 percentage of participants
Interval 31.7 to 62.1
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
sCR/CR after 1 year
|
62.2 percentage of participants
Interval 46.5 to 76.2
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
sCR after 1 year
|
60.0 percentage of participants
Interval 44.3 to 74.3
|
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Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
CR after 1 year
|
2.2 percentage of participants
Interval 0.0 to 11.8
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
MRDnegCR after 1 year'
|
53.5 percentage of participants
Interval 37.7 to 68.8
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
nCR after 1 year
|
11.1 percentage of participants
Interval 3.7 to 24.1
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
≥VGPR after 1 year
|
89 percentage of participants
Interval 75.6 to 96.3
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
ORR after 1 year
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
sCR/CR after 2 years
|
64.4 percentage of participants
Interval 48.8 to 78.1
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
sCR after 2 years
|
62.2 percentage of participants
Interval 46.5 to 76.2
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
CR after 2 years
|
2.2 percentage of participants
Interval 0.0 to 11.8
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
MRDnegCR after 2 years*
|
46.2 percentage of participants
Interval 30.1 to 62.8
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
nCR after 2 years
|
11.1 percentage of participants
Interval 3.7 to 24.1
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
≥VGPR after 2 years
|
91.1 percentage of participants
Interval 78.8 to 97.5
|
|
Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
ORR after 2 years
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
Adverse Events
Carfilzomib, Lenalidomide, and Dexamethasone
Serious events: 19 serious events
Other events: 45 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 participants at risk
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
2.2%
1/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Blood and lymphatic system disorders
Anemia
|
8.9%
4/45 • Number of events 8 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Investigations
CD4 lymphocytes decreased
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Hepatobiliary disorders
Cholecystitis
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Confusion
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Investigations
Creatinine increased
|
4.4%
2/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Immune system disorders
Cytokine release syndrome
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
2/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
5/45 • Number of events 10 • 4 years and 9 months and 2 days
|
|
General disorders
Edema limbs
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Enterocolitis infectious
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
General disorders
Fatigue
|
2.2%
1/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
General disorders
Fever
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
General disorders
General disorders and administration site conditions - Other, night sweats/tremors
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Hypertension
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Hypotension
|
4.4%
2/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Lung infection
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Investigations
Lymphocyte count decreased
|
6.7%
3/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Investigations
Neutrophil count decreased
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Investigations
Platelet count decreased
|
4.4%
2/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Presyncope
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Thromboembolic event
|
13.3%
6/45 • Number of events 6 • 4 years and 9 months and 2 days
|
|
Investigations
White blood cell decreased
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
General disorders
Death
|
4.4%
2/45 • Number of events 45 • 4 years and 9 months and 2 days
|
Other adverse events
| Measure |
Carfilzomib, Lenalidomide, and Dexamethasone
n=45 participants at risk
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
3/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
15.6%
7/45 • Number of events 9 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Agitation
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Investigations
Alanine aminotransferase increased
|
80.0%
36/45 • Number of events 166 • 4 years and 9 months and 2 days
|
|
Investigations
Alkaline phosphatase increased
|
64.4%
29/45 • Number of events 67 • 4 years and 9 months and 2 days
|
|
Immune system disorders
Allergic reaction
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Blood and lymphatic system disorders
Anemia
|
75.6%
34/45 • Number of events 148 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
5/45 • Number of events 7 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Anxiety
|
6.7%
3/45 • Number of events 5 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Appendicitis
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
10/45 • Number of events 10 • 4 years and 9 months and 2 days
|
|
Investigations
Aspartate aminotransferase increased
|
55.6%
25/45 • Number of events 71 • 4 years and 9 months and 2 days
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.6%
7/45 • Number of events 8 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Bloating
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Investigations
Blood bilirubin increased
|
51.1%
23/45 • Number of events 72 • 4 years and 9 months and 2 days
|
|
Eye disorders
Blurred vision
|
13.3%
6/45 • Number of events 6 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Bronchial infection
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Injury, poisoning and procedural complications
Bruising
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Investigations
CPK increased
|
22.2%
10/45 • Number of events 19 • 4 years and 9 months and 2 days
|
|
Cardiac disorders
Cardiac disorders - Other, cardiac NOS
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Eye disorders
Cataract
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
24.4%
11/45 • Number of events 14 • 4 years and 9 months and 2 days
|
|
General disorders
Chills
|
11.1%
5/45 • Number of events 6 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Cognitive disturbance
|
8.9%
4/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Concentration impairment
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Confusion
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Eye disorders
Conjunctivitis
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Constipation
|
55.6%
25/45 • Number of events 34 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
9/45 • Number of events 12 • 4 years and 9 months and 2 days
|
|
Investigations
Creatinine increased
|
40.0%
18/45 • Number of events 51 • 4 years and 9 months and 2 days
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Dehydration
|
8.9%
4/45 • Number of events 5 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Dental caries
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Depression
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
30/45 • Number of events 51 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Dizziness
|
8.9%
4/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Eye disorders
Dry eye
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
6/45 • Number of events 6 • 4 years and 9 months and 2 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Dysarthria
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Dysesthesia
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Dysgeusia
|
20.0%
9/45 • Number of events 10 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
6/45 • Number of events 6 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.4%
20/45 • Number of events 37 • 4 years and 9 months and 2 days
|
|
General disorders
Edema face
|
8.9%
4/45 • Number of events 5 • 4 years and 9 months and 2 days
|
|
General disorders
Edema limbs
|
37.8%
17/45 • Number of events 30 • 4 years and 9 months and 2 days
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Enterocolitis infectious
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Eye disorders
Eye disorders - Other, specify
|
17.8%
8/45 • Number of events 9 • 4 years and 9 months and 2 days
|
|
Injury, poisoning and procedural complications
Fall
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
General disorders
Fatigue
|
62.2%
28/45 • Number of events 43 • 4 years and 9 months and 2 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
General disorders
Fever
|
26.7%
12/45 • Number of events 18 • 4 years and 9 months and 2 days
|
|
General disorders
Flu like symptoms
|
11.1%
5/45 • Number of events 5 • 4 years and 9 months and 2 days
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
General disorders
Gait disturbance
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
17.8%
8/45 • Number of events 8 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
General disorders
General disorders and administration site conditions - Other, Gastrointeritis
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
General disorders
Generalized muscle weakness
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Gingival pain
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Eye disorders
Glaucoma
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Headache
|
33.3%
15/45 • Number of events 21 • 4 years and 9 months and 2 days
|
|
Cardiac disorders
Heart failure
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Hematoma
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.4%
2/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
13.3%
6/45 • Number of events 6 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Hot flashes
|
13.3%
6/45 • Number of events 7 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
22.2%
10/45 • Number of events 18 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
9/45 • Number of events 12 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
51.1%
23/45 • Number of events 35 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
57.8%
26/45 • Number of events 52 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Hypertension
|
11.1%
5/45 • Number of events 16 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
26.7%
12/45 • Number of events 25 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
93.3%
42/45 • Number of events 136 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
44.4%
20/45 • Number of events 36 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
10/45 • Number of events 19 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
37.8%
17/45 • Number of events 40 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.6%
16/45 • Number of events 33 • 4 years and 9 months and 2 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
64.4%
29/45 • Number of events 79 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Hypotension
|
4.4%
2/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Endocrine disorders
Hypothyroidism
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Infections and infestations - Other, specify
|
8.9%
4/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
General disorders
Infusion related reaction
|
6.7%
3/45 • Number of events 5 • 4 years and 9 months and 2 days
|
|
General disorders
Injection site reaction
|
71.1%
32/45 • Number of events 51 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Insomnia
|
57.8%
26/45 • Number of events 30 • 4 years and 9 months and 2 days
|
|
General disorders
Irritability
|
8.9%
4/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Laryngitis
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Libido decreased
|
2.2%
1/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Investigations
Lipase increased
|
2.2%
1/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Lung infection
|
4.4%
2/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Investigations
Lymphocyte count decreased
|
100.0%
45/45 • Number of events 438 • 4 years and 9 months and 2 days
|
|
Investigations
Lymphocyte count increased
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Memory impairment
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Mucositis oral
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
13.3%
6/45 • Number of events 9 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.1%
14/45 • Number of events 19 • 4 years and 9 months and 2 days
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Nausea
|
17.8%
8/45 • Number of events 10 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Investigations
Neutrophil count decreased
|
77.8%
35/45 • Number of events 207 • 4 years and 9 months and 2 days
|
|
Renal and urinary disorders
Nocturia
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Ear and labyrinth disorders
Otitis media
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
General disorders
Pain
|
42.2%
19/45 • Number of events 25 • 4 years and 9 months and 2 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
15/45 • Number of events 17 • 4 years and 9 months and 2 days
|
|
Cardiac disorders
Palpitations
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Eye disorders
Papilledema
|
2.2%
1/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Paresthesia
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial effusion
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Peripheral nerve infection
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
48.9%
22/45 • Number of events 33 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Personality change
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Phlebitis
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Investigations
Platelet count decreased
|
93.3%
42/45 • Number of events 214 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.9%
4/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Presyncope
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
6/45 • Number of events 8 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Psychiatric disorders - Other, Emotional lability
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.4%
2/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
60.0%
27/45 • Number of events 68 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Rectal pain
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Rhinorrhea; Rt. Pleural density
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Rhinitis infective
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Investigations
Serum amylase increased
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Cardiac disorders
Sinus bradycardia
|
8.9%
4/45 • Number of events 5 • 4 years and 9 months and 2 days
|
|
Cardiac disorders
Sinus tachycardia
|
4.4%
2/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Sinusitis
|
11.1%
5/45 • Number of events 6 • 4 years and 9 months and 2 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.1%
5/45 • Number of events 5 • 4 years and 9 months and 2 days
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Skin infection
|
8.9%
4/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Somnolence
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.7%
3/45 • Number of events 4 • 4 years and 9 months and 2 days
|
|
Psychiatric disorders
Suicidal ideation
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Superficial thrombophlebitis
|
6.7%
3/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Syncope
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Thromboembolic event
|
11.1%
5/45 • Number of events 6 • 4 years and 9 months and 2 days
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Tooth infection
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Toothache
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Nervous system disorders
Tremor
|
20.0%
9/45 • Number of events 11 • 4 years and 9 months and 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
66.7%
30/45 • Number of events 47 • 4 years and 9 months and 2 days
|
|
Renal and urinary disorders
Urinary frequency
|
4.4%
2/45 • Number of events 2 • 4 years and 9 months and 2 days
|
|
Renal and urinary disorders
Urinary incontinence
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Renal and urinary disorders
Urinary retention
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Urinary tract infection
|
4.4%
2/45 • Number of events 3 • 4 years and 9 months and 2 days
|
|
Infections and infestations
Vaginal infection
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Vascular disorders
Vascular disorders - Other, Raynaud's disorder
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Ear and labyrinth disorders
Vestibular disorder
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
4/45 • Number of events 7 • 4 years and 9 months and 2 days
|
|
Investigations
Weight loss
|
2.2%
1/45 • Number of events 1 • 4 years and 9 months and 2 days
|
|
Investigations
White blood cell decreased
|
84.4%
38/45 • Number of events 284 • 4 years and 9 months and 2 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place