Trial Outcomes & Findings for Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma (NCT NCT01816971)

Last Updated: 2025-06-10

Results Overview

The percentage of stringent complete response (CR) (sCR) will be reported along with 95% confidence intervals, adjusted for the two-stage nature of the trial design.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

Day 224

Results posted on

2025-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Overall Study STARTED	76
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) n=76 Participants INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	45 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	14 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	7 participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 224

The percentage of stringent complete response (CR) (sCR) will be reported along with 95% confidence intervals, adjusted for the two-stage nature of the trial design.

Outcome measures

Outcome measures
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) n=76 Participants INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Percentage of Patients Achieving sCR	76 percentage of participants Interval 66.0 to 84.0

SECONDARY outcome

Timeframe: Up to 5 years

Reported along with its exact 95% binomial confidence interval.

Outcome measures

Outcome measures
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) n=76 Participants INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Overall Response Rate, Defined as at Least a Partial Response to Therapy (> PR), at Least Very Good Partial Response (VGPR) and at Least Near Complete Response (nCR) Rate	97 percentage of participants Interval 91.0 to 100.0

SECONDARY outcome

Timeframe: Up to 5 years

Estimated using the product-limit method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) n=76 Participants INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Time to Progression	NA month With median follow-up time of 56.0 months, time to progression has not reached the median by the Kaplan-Meier method.

SECONDARY outcome

Timeframe: Up to 5 years

Reported along with its exact 95% binomial confidence interval. Estimated using the product-limit method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) n=76 Participants INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Duration of Response	NA month With median follow-up time of 56.0 months, duration of response has not reached the median by the Kaplan-Meier method.

SECONDARY outcome

Timeframe: Up to 5 years

Progression-free Survival rate was estimated at months 12, 24, 36, 48, and 60, by the product-limit method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) n=76 Participants INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Percentage of Participants With Progression-free Survival (PFS) PFS rate at 12 months (%)	97 percentage of participants
Percentage of Participants With Progression-free Survival (PFS) PFS rate at 24 months(%)	93 percentage of participants
Percentage of Participants With Progression-free Survival (PFS) PFS rate at 36 months(%)	80 percentage of participants
Percentage of Participants With Progression-free Survival (PFS) PFS rate at 48 months(%)	76 percentage of participants
Percentage of Participants With Progression-free Survival (PFS) PFS rate at 60 months(%)	72 percentage of participants

SECONDARY outcome

Timeframe: Up to 5 years

Overall survival rate was estimated at months 12, 24, 36, 48, and 60, by the product-limit method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) n=76 Participants INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Percentage of Participants With Overall Survival (OS) OS rate at 12 months (%)	100 percentage of participants
Percentage of Participants With Overall Survival (OS) OS rate at 24 months (%)	97 percentage of participants
Percentage of Participants With Overall Survival (OS) OS rate at 36 months (%)	96 percentage of participants
Percentage of Participants With Overall Survival (OS) OS rate at 48 months (%)	93 percentage of participants
Percentage of Participants With Overall Survival (OS) OS rate at 60 months (%)	84 percentage of participants

Adverse Events

Treatment (Dexamethasone, Carfilzomib, Lenalidomide)

Serious events: 27 serious events

Other events: 76 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) n=76 participants at risk INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Cardiac disorders serious cardiovascular events	35.5% 27/76 • Number of events 54 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
General disorders Fever	13.2% 10/76 • Number of events 10 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Infections and infestations Lung infection	2.6% 2/76 • Number of events 4 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
General disorders Non-cardiac chest pain, pleuritic	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Blood and lymphatic system disorders Febrile neutropenia	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Eye disorders Eye disorders	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Gastrointestinal disorders Diarrhea	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Gastrointestinal disorders Gastrointestinal disorders	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
General disorders Chills	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
General disorders Flu like symptoms	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Infections and infestations Upper respiratory infection	3.9% 3/76 • Number of events 3 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Infections and infestations Infections and infestations	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Infections and infestations Joint infection	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Injury, poisoning and procedural complications Fall	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Investigations Platelet count decreased	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Investigations Neutrophil count decreased	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Musculoskeletal and connective tissue disorders Musculoskeletal	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt lymphoma	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Nervous system disorders Seizure, tonic clonic	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Nervous system disorders Syncope	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Nervous system disorders Nervous system disorders	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Psychiatric disorders Agitation	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Renal and urinary disorders Acute kidney injury	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Infections and infestations shingles outbreak near port-a-cath site	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Vascular disorders Thromboembolic Event	5.3% 4/76 • Number of events 4 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Gastrointestinal disorders Abdominal Pain	1.3% 1/76 • Number of events 2 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Respiratory, thoracic and mediastinal disorders Aspiration	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Skin and subcutaneous tissue disorders Skin and subcutaneous disorders	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Infections and infestations Bacteremia	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Infections and infestations Enterocolitis Infection	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Investigations ALT Elevation	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Gastrointestinal disorders colitis	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Immune system disorders Cytokine Release Syndrome	1.3% 1/76 • Number of events 1 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.

Other adverse events

Other adverse events
Measure	Treatment (Dexamethasone, Carfilzomib, Lenalidomide) n=76 participants at risk INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
Cardiac disorders Cardiac disorders	13.2% 10/76 • Number of events 15 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Vascular disorders Thromboembolic events	18.4% 14/76 • Number of events 15 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Vascular disorders Hypertension	19.7% 15/76 • Number of events 23 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Metabolism and nutrition disorders Hypophosphatemia	28.9% 22/76 • Number of events 49 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Infections and infestations Rash	43.4% 33/76 • Number of events 62 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Nervous system disorders Peripheral neuropathy	42.1% 32/76 • Number of events 41 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Respiratory, thoracic and mediastinal disorders Dyspnea	39.5% 30/76 • Number of events 47 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Metabolism and nutrition disorders Hyperglycemia	43.4% 33/76 • Number of events 79 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Gastrointestinal disorders Diarrhea	51.3% 39/76 • Number of events 67 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
General disorders Fatigue	67.1% 51/76 • Number of events 111 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
Infections and infestations Infection	73.7% 56/76 • Number of events 136 • adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.

Additional Information

Andrzej Jakubowiak, MD, PhD

University of Chicago Medical Center

Phone: 773-702-4005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place