Trial Outcomes & Findings for KRDI in Transplant-Eligible MM (NCT NCT04430894)
NCT ID: NCT04430894
Last Updated: 2026-01-29
Results Overview
Percentage of patients who achieved a complete response (CR) or stringent CR (sCR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI). IMWG criteria define a CR as "Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow" and an sCR as "CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence."
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
112 Days
Results posted on
2026-01-29
Participant Flow
Participant milestones
| Measure |
Induction
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
KRDI in Transplant-Eligible MM
Baseline characteristics by cohort
| Measure |
Induction
n=50 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Age, Continuous
|
59 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=35 Participants
|
|
ISS Stage at Diagnosis
I
|
28 Participants
n=35 Participants
|
|
ISS Stage at Diagnosis
II
|
16 Participants
n=35 Participants
|
|
ISS Stage at Diagnosis
III
|
6 Participants
n=35 Participants
|
|
Revised ISS Stage at Diagnosis
I
|
16 Participants
n=35 Participants
|
|
Revised ISS Stage at Diagnosis
II
|
32 Participants
n=35 Participants
|
|
Revised ISS Stage at Diagnosis
III
|
2 Participants
n=35 Participants
|
|
ECOG Performance Status
0
|
28 Participants
n=35 Participants
|
|
ECOG Performance Status
1
|
22 Participants
n=35 Participants
|
|
High Risk Cytogenetics
Yes
|
23 Participants
n=35 Participants
|
|
High Risk Cytogenetics
No
|
23 Participants
n=35 Participants
|
|
High Risk Cytogenetics
Unknown
|
4 Participants
n=35 Participants
|
|
Serum Heavy Light Chain
IgG
|
20 Participants
n=35 Participants
|
|
Serum Heavy Light Chain
IgA
|
13 Participants
n=35 Participants
|
|
Serum Heavy Light Chain
Light-chain only
|
10 Participants
n=35 Participants
|
|
Serum Heavy Light Chain
Unknown
|
7 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 112 DaysPercentage of patients who achieved a complete response (CR) or stringent CR (sCR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI). IMWG criteria define a CR as "Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow" and an sCR as "CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence."
Outcome measures
| Measure |
Induction
n=47 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Complete Response (CR + Stringent CR) Rate
|
19 Participants
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SECONDARY outcome
Timeframe: 112 days (4 cycles)Overall response rate will be the percentage of patients who achieve at least partial response (PR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI). The IMWG response criteria define a PR as: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h, OR If the serum and urine M-protein are unmeasurable, a \> 50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, OR If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \> 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \> 30%. In addition to the above listed criteria, if present at baseline, a \> 50% reduction in the size of soft tissue plasmacytomas is also required for a partial response.
Outcome measures
| Measure |
Induction
n=47 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Overall Response Rate After 4 Cycles Induction Therapy
|
47 Participants
|
SECONDARY outcome
Timeframe: 112 Days (4 Cycles)Population: After cycle 4, 28 patients out of 47 patients evaluable for response had evaluable MRD data.
MRD is the small number myeloma cells surviving in the bone marrow after a clinical response has been measured and the patient is in remission. MRD negativity will be determined by deep sequencing of genomic deoxyribonucleic acid from bone marrow samples using rearranged Ig locus-specific primers (Adaptive, Seattle, WA). The MRD rate after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI) is the percentage of patients who are MRD negative at 10\^(-5) and 10\^(-6), meaning that no MRD was detected in samples of 100,000 cells and 1,000,000 cells, respectively.
Outcome measures
| Measure |
Induction
n=28 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Minimal Residual Disease (MRD) Rate After 4 Cycles Induction Therapy
MRD negative at 10^(-5)
|
12 Participants
|
|
Minimal Residual Disease (MRD) Rate After 4 Cycles Induction Therapy
MRD negative at 10^(-6)
|
9 Participants
|
SECONDARY outcome
Timeframe: 168 Days (6 cycles, upfront transplant)Population: Of all patients enrolled to the main arm of the protocol (induction), 47 were evaluable for response. Of these 47 patients, 5 received upfront stem cell transplant. All five patients receiving upfront SCT had evaluable MRD results.
MRD is the small number myeloma cells surviving in the bone marrow after a clinical response has been measured and the patient is in remission. MRD negativity will be determined by deep sequencing of genomic deoxyribonucleic acid from bone marrow samples using rearranged Ig locus-specific primers (Adaptive, Seattle, WA). The MRD rate is the percentage of patients who are MRD negative at 10\^(-5), meaning that no MRD was detected in a sample of 100,000 cells. MRD status was assessed after 4 cycles of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI) induction, stem cell transplant, and 2 cycles of KRDI consolidation therapy (6 cycles total.)
Outcome measures
| Measure |
Induction
n=5 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Minimal Residual Disease (MRD) Rate at 10^(-5) in Patients Receiving Upfront Stem Cell Transplant
|
20 percentage of participants
|
SECONDARY outcome
Timeframe: 224 Days (8 cycles transplant-deferred)Population: Of all patients enrolled to the main arm of the protocol (induction), 47 were evaluable for response. Of these 47 patients, 42 deferred stem cell transplant. 35 of these 42 patients had evaluable MRD results.
MRD is the small number myeloma cells surviving in the bone marrow after a clinical response has been measured and the patient is in remission. MRD negativity will be determined by deep sequencing of genomic deoxyribonucleic acid from bone marrow samples using rearranged Ig locus-specific primers (Adaptive, Seattle, WA). The MRD rate is the percentage of patients who are MRD negative at 10\^(-5), meaning that no MRD was detected in a sample of 100,000 cells. MRD status was assessed after 4 cycles of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI) induction, stem cell collection, and 4 additional cycles of KRDI (8 cycles total).
Outcome measures
| Measure |
Induction
n=35 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Minimal Residual Disease (MRD) Rate at 10^(-5) in Patients Deferring Stem Cell Transplant
|
26 Participants
|
SECONDARY outcome
Timeframe: 12 monthsProgression free survival (PFS) is defined as the time between the start of treatment and disease progression or death due to any cause. PFS at 12 months is the percentage of patients who were alive and without disease progression 12 months after initiating treatment with of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI).
Outcome measures
| Measure |
Induction
n=47 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Progression Free Survival at 12 Months
|
97.9 percentage of participants
Interval 95.9 to 99.7
|
SECONDARY outcome
Timeframe: 12 monthsOverall survival (OS) is defined as the time between the start of treatment and death due to any cause. OS at 12 months is the percentage of patients who were alive 12 months after initiating treatment with of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI).
Outcome measures
| Measure |
Induction
n=47 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Overall Survival at 12 Months
|
97.9 percentage of participants
Interval 86.1 to 99.7
|
SECONDARY outcome
Timeframe: 168 DaysPopulation: Of all patients enrolled to the main arm of the protocol (induction), 47 were evaluable for response. Of these 47 patients, 5 received upfront stem cell transplant.
Percentage of patients who achieved a complete response (CR) or stringent CR (sCR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI), stem cell transplant, and 2 cycles of KRDI consolidation (6 cycles total). IMWG criteria define a CR as "Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow" and an sCR as "CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence."
Outcome measures
| Measure |
Induction
n=5 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
|
Complete Response Rate in Patients With Upfront Stem Cell Transplant
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: 224 DaysPopulation: Of all patients enrolled to the main arm of the protocol (induction), 47 were evaluable for response. Of these 47 patients, 42 deferred stem cell transplant.
Percentage of patients who achieved a complete response (CR) or stringent CR (sCR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI), stem cell collection, and 4 additional cycles of KRDI after deferring stem cell transplant (8 cycles total). IMWG criteria define a CR as "Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow" and an sCR as "CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence."
Outcome measures
| Measure |
Induction
n=42 Participants
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
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Complete Response Rate in Patients Deferring Stem Cell Transplant
|
67 percentage of participants
|
Adverse Events
Induction
Serious events: 8 serious events
Other events: 49 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Induction
n=50 participants at risk
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
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|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Appendicitis
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Eye disorders
Eye disorders - Other, specify
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Immune system disorders
Cytokine release syndrome
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Fever
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.0%
2/50 • Number of events 2 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Right Hip Fracture
|
2.0%
1/50 • Number of events 1 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
Other adverse events
| Measure |
Induction
n=50 participants at risk
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)
For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).
For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.
Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
5/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.0%
14/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Renal and urinary disorders
Renal and urinary disorder - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Eye disorders
Vision decreased
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
6/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Weight loss
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
White blood cell decreased
|
52.0%
26/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Wound complication
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Psychiatric disorders
Agitation
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Alanine aminotransferase increased
|
48.0%
24/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Alkaline phosphatase increased
|
34.0%
17/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Immune system disorders
Allergic Reaction
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Blood and lymphatic system disorders
Anemia
|
42.0%
21/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Anorexia
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Psychiatric disorders
Anxiety
|
16.0%
8/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.0%
4/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Aspartate aminotransferase increased
|
28.0%
14/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Immune system disorders
Autoimmune Disorder
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
38.0%
19/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Bloating
|
8.0%
4/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Blood bilirubin increased
|
12.0%
6/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Blood lactate dehydrogenase increased
|
20.0%
10/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Eye disorders
Blurred vision
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
10/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Bruising
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Cardiac troponin T increased
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Eye disorders
Cataract
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Chills
|
10.0%
5/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Cholesterol high
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Concentration impairment
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Conjunctivitis
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Constipation
|
26.0%
13/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
8/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Creatinine increased
|
16.0%
8/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Cardiac disorders
Cyanosis
|
34.0%
17/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Psychiatric disorders
Depression
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
20/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Dizziness
|
24.0%
12/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
5/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Dysgeusia
|
14.0%
7/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.0%
16/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Edema limbs
|
28.0%
14/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Eye disorders
Eye disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Fatigue
|
70.0%
35/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Fever
|
20.0%
10/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Flu like symptoms
|
10.0%
5/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Vascular disorders
Flushing
|
8.0%
4/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Fracture, anterior ribs and wrist
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Gait disturbance
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.0%
4/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
GGT increased
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Hallucinations
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Headache
|
30.0%
15/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Vascular disorders
Hematoma
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Renal and urinary disorders
Hematuria
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.0%
4/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Vascular disorders
Hot flashes
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.0%
22/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
12.0%
6/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Vascular disorders
Hypertension
|
44.0%
22/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Endocrine disorders
Hyperthyroidism
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.0%
8/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.0%
8/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
44.0%
22/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.0%
8/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.0%
9/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
44.0%
22/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Vascular disorders
Hypotension
|
8.0%
4/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Endocrine disorders
Hypothyroidism
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Infections and infestations - Other, specify
|
18.0%
9/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Infused related reaction
|
20.0%
10/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Injection site reaction
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Psychiatric disorders
Insomnia
|
42.0%
21/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Psychiatric disorders
Irritability
|
8.0%
4/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Localized edema
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Viral Meningitis
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
14.0%
7/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
6/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.0%
9/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Nausea
|
46.0%
23/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.0%
4/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Neutrophil count decreased
|
58.0%
29/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Non-cardiac chest pain
|
12.0%
6/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Metabolism and nutrition disorders
Obesity
|
8.0%
4/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Oral pain
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
General disorders
Pain
|
10.0%
5/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.0%
8/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Papulopustular rash
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Paresthesia
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.0%
7/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Investigations
Platelet count decreased
|
32.0%
16/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Renal and urinary disorders
Proteinuria
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Psychiatric disorders
Restlessness
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Rhinitis infective
|
44.0%
22/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Cardiac disorders
Sinus bradycardia
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Cardiac disorders
Sinus tachycardia
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Sinusitis
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Skin infection
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Stomach pain
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Reproductive system and breast disorders
Testicular disorder
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Vascular disorders
Thromboembolic event
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Thrush
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Tooth development disorder
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Tooth Infection
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Gastrointestinal disorders
Toothache
|
4.0%
2/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Nervous system disorders
Tremor
|
6.0%
3/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Infections and infestations
Upper respiratory infection
|
18.0%
9/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Renal and urinary disorders
Urinary tract pain
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Renal and urinary disorders
Urinary urgency
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.0%
1/50 • The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
|
Additional Information
Elizabeth K. O'Donnell, MD
Dana-Farber Cancer Institute
Phone: 617-632-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place