Trial Outcomes & Findings for Study of Initial Treatment With Elotuzumab, Carfilzomib, Lenalidomide and Dexamethasone in Multiple Myeloma (NCT NCT02969837)

NCT ID: NCT02969837

Last Updated: 2026-01-16

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Landmark evaluations were performed after cycles 4, 8, 12, 18 and 24 (that is, 4, 8, 12, 18 and 24 months)

Results posted on

2026-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Elo-KRd Regimen Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
Overall Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Initial Treatment With Elotuzumab, Carfilzomib, Lenalidomide and Dexamethasone in Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elo-KRd Regimen n=46 Participants Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
Age, Continuous	62 years n=9 Participants
Sex: Female, Male Female	13 Participants n=9 Participants
Sex: Female, Male Male	33 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	6 Participants n=9 Participants
Race (NIH/OMB) White	32 Participants n=9 Participants
Race (NIH/OMB) More than one race	3 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=9 Participants

PRIMARY outcome

Timeframe: Landmark evaluations were performed after cycles 4, 8, 12, 18 and 24 (that is, 4, 8, 12, 18 and 24 months)

Population: One censored because of autologous stem cell transplant cycle 8 without progression

Outcome measures

Outcome measures
Measure	Elo-KRd Regimen n=45 Participants Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
Number of Participants With Stringent Complete Response (sCR)	17 Participants

PRIMARY outcome

Timeframe: Landmark evaluations were performed after cycle 8

Population: One censored because of autologous stem cell transplant cycle 8 without progression

Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycle 8. The flow cytometry analysis procedure used to determine MRD is performed on a NAVIOS FLOW CYTOMETER SYSTEM manufactured by BECKMAN COULTER, INC., using a laboratory developed assay. The Premarket Notification 510(k) (Number K130373) for the device can be found using the following link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130373.

Outcome measures

Outcome measures
Measure	Elo-KRd Regimen n=45 Participants Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
Number of Participants With MRD-negativity (10^-5) After C8 Elo-KRd	26 Participants

PRIMARY outcome

Timeframe: Landmark evaluations were performed after cycles 4, 8, 12, 18 and 24 (that is, 4, 8, 12, 18 and 24 months)

Population: One censored because of autologous stem cell transplant cycle 8 without progression

Response will be determined according to the International Myeloma Working Group (IMWG) response criteria for multiple myeloma. sCR is defined as CR plus : * normal FLC ratio and * absence of clonal cells in bone marrow by immunohistochemistry or 2 - 4 color flow cytometry CR is defined as below : * Negative immunofixation on the serum and urine and * disappearance of any soft tissue plasmacytomas and * \< 5% plasma cells in bone marrow. * In subjects with only FLC disease, a normal FLC ratio of 0.26-1.65 is required. Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 4,8,12,18 and 24. The flow cytometry analysis procedure used to determine MRD is performed on a NAVIOS FLOW CYTOMETER SYSTEM manufactured by BECKMAN COULTER, INC., using a laboratory developed assay.

Outcome measures

Outcome measures
Measure	Elo-KRd Regimen n=45 Participants Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
The Number of Participants With Stringent Complete Response (sCR) and/or MRD Negative (10^-5) by NGS	26 Participants

SECONDARY outcome

Timeframe: AEs were recorded from the day of signed consent through 30 days after the last does of Elo-KRd or initiation of new therapy, an average of 2 years.

AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

Outcome measures

Outcome measures
Measure	Elo-KRd Regimen n=46 Participants Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Infusion reactions	5 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Acute kidney injury	5 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Nausea	16 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Hyperglycemia	14 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Anemia	11 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Neutropenia	9 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Thrombocytopenia	8 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Lymphopenia	4 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Fatigue	33 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Infection-Upper respiratory	19 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Infection-Non-pulmonary	22 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Infection-Lung	7 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Infection-Bronchial	2 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Diarrhea	29 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Dyspnea	20 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Peripheral neuropathy	19 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Cardia events, any	12 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Electrolyte imbalances, any	12 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Hypertension	11 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Rash	7 Participants
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Thromboembolic events	5 Participants

SECONDARY outcome

Timeframe: Up to two years

These events will be analyzed at differing points of time based on the individual subjects disease progression. It will be measured by the number of cycles of therapy.

Outcome measures

Outcome measures
Measure	Elo-KRd Regimen n=46 Participants Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
Duration of Response	23 cycles of therapy Interval 2.0 to 39.0

SECONDARY outcome

Timeframe: up to two years

Progression free survival (PFS) was assessed based on time to disease progression or death (whichever occurred first) from the start of treatment.

Outcome measures

Outcome measures
Measure	Elo-KRd Regimen n=46 Participants Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
Median Progression Free Survival	NA months Median PFS has not been reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: up to two years

Overall survival (OS) was assessed based on time to disease progression or death (whichever occurred first) from the start of treatment.

Outcome measures

Outcome measures
Measure	Elo-KRd Regimen n=46 Participants Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
Median Overall Survival	NA months Median OS has not been reached due to insufficient number of participants with events.

Adverse Events

Elo-KRd Regimen

Serious events: 18 serious events

Other events: 42 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Elo-KRd Regimen n=46 participants at risk Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
Renal and urinary disorders Acute kidney injury	2.2% 1/46 • Up to 2 years
Cardiac disorders Atrial fibrillation	2.2% 1/46 • Up to 2 years
Infections and infestations Bronchial infection	2.2% 1/46 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	2.2% 1/46 • Up to 2 years
Investigations Ejection fraction decreased	2.2% 1/46 • Up to 2 years
Blood and lymphatic system disorders Febrile neutropenia	4.3% 2/46 • Up to 2 years
General disorders Fever	4.3% 2/46 • Up to 2 years
Metabolism and nutrition disorders Hyperglycemia	2.2% 1/46 • Up to 2 years
Vascular disorders Hypotension	2.2% 1/46 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Hypoxia	2.2% 1/46 • Up to 2 years
Infections and infestations Infections and infestations - Other	2.2% 1/46 • Up to 2 years
Infections and infestations Lung infection	10.9% 5/46 • Up to 2 years
Cardiac disorders Myocardial infraction	2.2% 1/46 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 1/46 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	2.2% 1/46 • Up to 2 years
Renal and urinary disorders Renal and urinary disorders - Other	2.2% 1/46 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.2% 1/46 • Up to 2 years
Vascular disorders Thromboembolic event	2.2% 1/46 • Up to 2 years

Other adverse events

Other adverse events
Measure	Elo-KRd Regimen n=46 participants at risk Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression. Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15 Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles. Dexamethasone: Dexamethasone will be given as follows: Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
General disorders Localized edema	15.2% 7/46 • Up to 2 years
Investigations Lymphocyte count decreased	6.5% 3/46 • Up to 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	15.2% 7/46 • Up to 2 years
Gastrointestinal disorders Nausea	30.4% 14/46 • Up to 2 years
Investigations Neutrophil count decreased	13.0% 6/46 • Up to 2 years
Nervous system disorders Paresthesia	8.7% 4/46 • Up to 2 years
Nervous system disorders Peripheral sensory neuropathy	37.0% 17/46 • Up to 2 years
Investigations Platelet count decreased	15.2% 7/46 • Up to 2 years
Skin and subcutaneous tissue disorders Pruritus	8.7% 4/46 • Up to 2 years
Skin and subcutaneous tissue disorders Rash maculo-papular	13.0% 6/46 • Up to 2 years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders- Other	10.9% 5/46 • Up to 2 years
Vascular disorders Thromboembolic event	8.7% 4/46 • Up to 2 years
Nervous system disorders Tremor	8.7% 4/46 • Up to 2 years
Infections and infestations Upper respiratory infection	15.2% 7/46 • Up to 2 years
Gastrointestinal disorders Vomiting	6.5% 3/46 • Up to 2 years
Investigations Weight gain	10.9% 5/46 • Up to 2 years
Investigations White blood cell decreased	21.7% 10/46 • Up to 2 years
Cardiac disorders Cardiac disorders - Other	6.5% 3/46 • Up to 2 years
General disorders Chills	6.5% 3/46 • Up to 2 years
Nervous system disorders Dysgeusia	6.5% 3/46 • Up to 2 years
General disorders Flu like symptoms	6.5% 3/46 • Up to 2 years
Gastrointestinal disorders Gastroesophageal reflux disease	8.7% 4/46 • Up to 2 years
General disorders General disorders and administration site conditions-Other	6.5% 3/46 • Up to 2 years
Nervous system disorders Headache	6.5% 3/46 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Hoarseness	6.5% 3/46 • Up to 2 years
Metabolism and nutrition disorders Hypokalemia	10.9% 5/46 • Up to 2 years
Vascular disorders Hypotension	6.5% 3/46 • Up to 2 years
Gastrointestinal disorders Mucositis oral	6.5% 3/46 • Up to 2 years
Musculoskeletal and connective tissue disorders Myalgia	6.5% 3/46 • Up to 2 years
Infections and infestations Sinusitis	6.5% 3/46 • Up to 2 years
Psychiatric disorders Agitation	6.5% 3/46 • Up to 2 years
Investigations Alanine aminotransferase increased	19.6% 9/46 • Up to 2 years
Blood and lymphatic system disorders Anemia	15.2% 7/46 • Up to 2 years
Investigations Aspartate aminotransferase increased	8.7% 4/46 • Up to 2 years
Cardiac disorders Atrial fibrillation	6.5% 3/46 • Up to 2 years
Eye disorders Blurred vision	8.7% 4/46 • Up to 2 years
Gastrointestinal disorders Constipation	13.0% 6/46 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Cough	10.9% 5/46 • Up to 2 years
Gastrointestinal disorders Diarrhea	45.7% 21/46 • Up to 2 years
Nervous system disorders Dizziness	15.2% 7/46 • Up to 2 years
Gastrointestinal disorders Dyspepsia	8.7% 4/46 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	28.3% 13/46 • Up to 2 years
General disorders Edema limbs	37.0% 17/46 • Up to 2 years
General disorders Fatigue	63.0% 29/46 • Up to 2 years
General disorders Fever	17.4% 8/46 • Up to 2 years
Metabolism and nutrition disorders Hyperglycemia	23.9% 11/46 • Up to 2 years
Vascular disorders Hypertension	15.2% 7/46 • Up to 2 years
General disorders Infusion related reaction	8.7% 4/46 • Up to 2 years
Psychiatric disorders Insomnia	28.3% 13/46 • Up to 2 years

Additional Information

Member of the Biostatistics Lab

University of Chicago

Phone: 773.702.2453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place