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Trial record 66 of 372 for:    LENALIDOMIDE AND Dexamethasone

Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01402284
Recruitment Status : Active, not recruiting
First Posted : July 26, 2011
Results First Posted : May 16, 2017
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
Celgene
Onyx Therapeutics, Inc.
Information provided by (Responsible Party):
Dickran Kazandjian, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Carfilzomib
Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone Therapy
Hide Arm/Group Description Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Period Title: Overall Study
Started 45
Completed 31
Not Completed 14
Reason Not Completed
Withdrawal consent             1
Follows up at Memorial Sloan Kettering             2
Physician Decision             1
Disease progression on study             8
Non compliance             2
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  57.8%
>=65 years
19
  42.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
60
(40 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
18
  40.0%
Male
27
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
45
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   4.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  13.3%
White
37
  82.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
 100.0%
Isotypes   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 45 participants
IgG kappa 51
IgG lambda 16
IgA kappa 9
IgA lambda 9
Free kappa 9
Free lambda 4
[1]
Measure Description: Measure Description: IgA Kappa, IgG Kappa, IgG Lambda, Free Kappa and Free lambda were measured in the urine to determine changes in renal function. Measurable is defined as any of the following: Serum monoclonal protein greater than or equal to 1.0 g/dL, urine monoclonal protein greater than 200 mg/24 hour, and serum immunoglobulin free light chain greater than 10mg/dL AND abnormal kappa/lambda ratio.
1.Primary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events
Hide Description Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame 4 years and 9 months and 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description:
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
45
 100.0%
2.Secondary Outcome
Title Overall Response Rate
Hide Description Response is assessed by the International Myeloma Working Group Criteria. Patients who attained a partial response or better (BoR) response by the end of induction. Partial response is ≥50% reduction of serum M-protein and reduction in 24h urinary M-protein.
Time Frame 48.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description:
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.8
(88.2 to 99.9)
3.Secondary Outcome
Title Progression Free Survival (PFS) at 48 Months
Hide Description PFS is defined as time of start of treatment to time of progression or death, whichever occurs first. Response is assessed by the International Myeloma Working Group Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be >10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description:
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79.2
(63.8 to 88.6)
4.Secondary Outcome
Title Percentage of Responders With Duration of Response (DOR) at 48 Months
Hide Description Response is assessed by the International Myeloma Working Group Criteria. DOR is measured from the time measurement criteria are met for a partial response or better until first date that recurrent or progressive disease is objectively documented. Partial response is ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24h. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be >10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description:
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.1
(65.7 to 90.1)
5.Secondary Outcome
Title Overall Survival (OS) Rate
Hide Description OS is defined as the time of start of treatment to death from any cause.
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description:
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.5
(63.6 to 97.3)
6.Secondary Outcome
Title Cluster of Differentiation 138 (CD138) + Plasma Cells Gene Expression Profiling on Pre and Post Carfilzomib Exposure Bone Marrow Samples
Hide Description Cluster of differentiation 138+ (CD138)+ plasma cells purified from bone marrow aspirates to identify potential markers of early progression. Changes in selected genes were confirmed by quantitative polymerase chain reaction (PCR) if suggested to be related to risk of progression to multiple myeloma.
Time Frame Cycle 1 Day 1, an average of 28 days ± 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected due to lack of financial resources.
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description:
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Rate of Minimal Residual Disease (MRD) by Flow Cytometry
Hide Description Response is assessed by the International Myeloma Working Group Criteria. Complete response is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains. Immunophenotyping is performed by multi-parametric flow cytometry.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description:
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44.4
(29.6 to 60.0)
8.Secondary Outcome
Title Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance
Hide Description Response is assessed by the International Myeloma Working Group Criteria. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains (FLC). Complete response is negative immunofixation on serum, and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Stringent complete response (sCR) is normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. Near complete response (nCR) is the absence of myeloma protein on electrophoresis, independent of immunofixation status. Very good partial response (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24h. Overall response rate (ORR) is patients who attained a partial response (PR) (≥50% reduction of serum M-protein and reduction in 24h urinary M-protein) or better (BoR) response.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
*Six patients withdrew from the study, four due to non-compliance and two to continue treatment at another institution. `One patient refused to have a bone marrow biopsy procedure and one patient withdrew due to non-compliance. CR (n=0) after 8 cycles.
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description:
Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
sCR/CR after 8 cycles Number Analyzed 21 participants
46.7
(31.7 to 62.1)
MRDnegCR after 8 cycles Number Analyzed 20 participants
44.4
(29.6 to 60.0)
nCR after 8 cycles Number Analyzed 9 participants
20
(9.6 to 34.6)
≥VGPR after 8 cycles Number Analyzed 40 participants
89
(75.6 to 96.3)
ORR after 8 cycles Number Analyzed 44 participants
97.8
(88.2 to 99.9)
sCR after 8 cycles Number Analyzed 21 participants
46.7
(31.7 to 62.1)
sCR/CR after 1 year Number Analyzed 28 participants
62.2
(46.5 to 76.2)
sCR after 1 year Number Analyzed 27 participants
60.0
(44.3 to 74.3)
CR after 1 year Number Analyzed 1 participants
2.2
(0 to 11.8)
MRDnegCR after 1 year` Number Analyzed 23 participants
53.5
(37.7 to 68.8)
nCR after 1 year Number Analyzed 5 participants
11.1
(3.7 to 24.1)
≥VGPR after 1 year Number Analyzed 40 participants
89
(75.6 to 96.3)
ORR after 1 year Number Analyzed 44 participants
97.8
(88.2 to 99.9)
sCR/CR after 2 years Number Analyzed 29 participants
64.4
(48.8 to 78.1)
sCR after 2 years Number Analyzed 28 participants
62.2
(46.5 to 76.2)
CR after 2 years Number Analyzed 1 participants
2.2
(0 to 11.8)
MRDnegCR after 2 years* Number Analyzed 18 participants
46.2
(30.1 to 62.8)
nCR after 2 years Number Analyzed 5 participants
11.1
(3.7 to 24.1)
≥VGPR after 2 years Number Analyzed 41 participants
91.1
(78.8 to 97.5)
ORR after 2 years Number Analyzed 44 participants
97.8
(88.2 to 99.9)
Time Frame 4 years and 9 months and 2 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carfilzomib, Lenalidomide, and Dexamethasone
Hide Arm/Group Description Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
All-Cause Mortality
Carfilzomib, Lenalidomide, and Dexamethasone
Affected / at Risk (%)
Total   3/45 (6.67%)    
Show Serious Adverse Events Hide Serious Adverse Events
Carfilzomib, Lenalidomide, and Dexamethasone
Affected / at Risk (%) # Events
Total   19/45 (42.22%)    
Blood and lymphatic system disorders   
Anemia  1  4/45 (8.89%)  8
Cardiac disorders   
Supraventricular tachycardia  1  1/45 (2.22%)  1
Endocrine disorders   
Adrenal insufficiency  1  1/45 (2.22%)  2
Gastrointestinal disorders   
Diarrhea  1  1/45 (2.22%)  1
Enterocolitis infectious  1  2/45 (4.44%)  2
General disorders   
Edema limbs  1  2/45 (4.44%)  2
Fatigue  1  1/45 (2.22%)  3
Fever  1  3/45 (6.67%)  3
General disorders and administration site conditions - Other, night sweats/tremors  1  1/45 (2.22%)  1
Death  1  2/45 (4.44%)  45
Hepatobiliary disorders   
Cholecystitis  1  1/45 (2.22%)  1
Immune system disorders   
Cytokine release syndrome  1  1/45 (2.22%)  1
Infections and infestations   
Infections and infestations - Other, specify  1  1/45 (2.22%)  1
Lung infection  1  3/45 (6.67%)  3
Investigations   
Alanine aminotransferase increased  1  1/45 (2.22%)  1
CD4 lymphocytes decreased  1  1/45 (2.22%)  1
Creatinine increased  1  2/45 (4.44%)  3
Lymphocyte count decreased  1  3/45 (6.67%)  4
Neutrophil count decreased  1  1/45 (2.22%)  1
Platelet count decreased  1  2/45 (4.44%)  4
White blood cell decreased  1  1/45 (2.22%)  1
Metabolism and nutrition disorders   
Dehydration  1  2/45 (4.44%)  3
Hypercalcemia  1  1/45 (2.22%)  1
Hyponatremia  1  2/45 (4.44%)  2
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/45 (2.22%)  1
Nervous system disorders   
Presyncope  1  1/45 (2.22%)  1
Psychiatric disorders   
Confusion  1  1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1  1/45 (2.22%)  1
Dyspnea  1  5/45 (11.11%)  10
Hiccups  1  1/45 (2.22%)  1
Hypoxia  1  1/45 (2.22%)  1
Pleural effusion  1  2/45 (4.44%)  2
Respiratory failure  1  1/45 (2.22%)  1
Vascular disorders   
Hypertension  1  1/45 (2.22%)  1
Hypotension  1  2/45 (4.44%)  3
Thromboembolic event  1  6/45 (13.33%)  6
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carfilzomib, Lenalidomide, and Dexamethasone
Affected / at Risk (%) # Events
Total   45/45 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  34/45 (75.56%)  148
Febrile neutropenia  1  1/45 (2.22%)  1
Cardiac disorders   
Atrioventricular block first degree  1  1/45 (2.22%)  1
Cardiac disorders - Other, cardiac NOS  1  1/45 (2.22%)  1
Electrocardiogram QT corrected interval prolonged  1  1/45 (2.22%)  1
Heart failure  1  2/45 (4.44%)  2
Palpitations  1  3/45 (6.67%)  3
Sinus bradycardia  1  4/45 (8.89%)  5
Sinus tachycardia  1  2/45 (4.44%)  3
Ventricular arrhythmia  1  1/45 (2.22%)  1
Ear and labyrinth disorders   
Otitis media  1  1/45 (2.22%)  1
Tinnitus  1  1/45 (2.22%)  1
Vertigo  1  1/45 (2.22%)  1
Vestibular disorder  1  1/45 (2.22%)  1
Endocrine disorders   
Hypothyroidism  1  2/45 (4.44%)  2
Eye disorders   
Blurred vision  1  6/45 (13.33%)  6
Cataract  1  1/45 (2.22%)  1
Conjunctivitis  1  1/45 (2.22%)  1
Dry eye  1  1/45 (2.22%)  1
Eye disorders - Other, specify  1 [1]  8/45 (17.78%)  9
Glaucoma  1  2/45 (4.44%)  2
Papilledema  1  1/45 (2.22%)  2
Gastrointestinal disorders   
Abdominal pain  1  3/45 (6.67%)  4
Anal hemorrhage  1  1/45 (2.22%)  1
Bloating  1  2/45 (4.44%)  2
Constipation  1  25/45 (55.56%)  34
Dental caries  1  1/45 (2.22%)  1
Diarrhea  1  30/45 (66.67%)  51
Dry mouth  1  6/45 (13.33%)  6
Dyspepsia  1  6/45 (13.33%)  6
Enterocolitis infectious  1  1/45 (2.22%)  1
Gastric ulcer  1  1/45 (2.22%)  1
Gastritis  1  3/45 (6.67%)  3
Gastroesophageal reflux disease  1  8/45 (17.78%)  8
Gastrointestinal disorders - Other, specify  1  1/45 (2.22%)  1
Gingival pain  1  1/45 (2.22%)  1
Lower gastrointestinal hemorrhage  1  1/45 (2.22%)  1
Mucositis oral  1  1/45 (2.22%)  1
Nausea  1  8/45 (17.78%)  10
Rectal hemorrhage  1  1/45 (2.22%)  1
Rectal pain  1  1/45 (2.22%)  1
Toothache  1  2/45 (4.44%)  2
Vomiting  1  4/45 (8.89%)  7
General disorders   
Chills  1  5/45 (11.11%)  6
Edema face  1  4/45 (8.89%)  5
Edema limbs  1  17/45 (37.78%)  30
Fatigue  1  28/45 (62.22%)  43
Fever  1  12/45 (26.67%)  18
Flu like symptoms  1  5/45 (11.11%)  5
Gait disturbance  1  1/45 (2.22%)  1
General disorders and administration site conditions - Other, Gastrointeritis  1  1/45 (2.22%)  1
Generalized muscle weakness  1  1/45 (2.22%)  1
Infusion related reaction  1  3/45 (6.67%)  5
Injection site reaction  1  32/45 (71.11%)  51
Irritability  1  4/45 (8.89%)  4
Pain  1  19/45 (42.22%)  25
Hepatobiliary disorders   
Gallbladder obstruction  1  1/45 (2.22%)  1
Immune system disorders   
Allergic reaction  1  1/45 (2.22%)  1
Infections and infestations   
Appendicitis  1  1/45 (2.22%)  1
Bronchial infection  1  1/45 (2.22%)  1
Infections and infestations - Other, specify  1 [2]  4/45 (8.89%)  4
Laryngitis  1  1/45 (2.22%)  1
Lung infection  1  2/45 (4.44%)  4
Peripheral nerve infection  1  1/45 (2.22%)  1
Rhinitis infective  1  1/45 (2.22%)  1
Sinusitis  1  5/45 (11.11%)  6
Skin infection  1  4/45 (8.89%)  4
Tooth infection  1  1/45 (2.22%)  1
Urinary tract infection  1  2/45 (4.44%)  3
Vaginal infection  1  1/45 (2.22%)  1
Injury, poisoning and procedural complications   
Bruising  1  2/45 (4.44%)  2
Fall  1  2/45 (4.44%)  2
Fracture  1  1/45 (2.22%)  1
Radiation recall reaction (dermatologic)  1  1/45 (2.22%)  1
Vascular access complication  1  1/45 (2.22%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  7/45 (15.56%)  9
Alanine aminotransferase increased  1  36/45 (80.00%)  166
Alkaline phosphatase increased  1  29/45 (64.44%)  67
Aspartate aminotransferase increased  1  25/45 (55.56%)  71
Blood bilirubin increased  1  23/45 (51.11%)  72
CPK increased  1  10/45 (22.22%)  19
Creatinine increased  1  18/45 (40.00%)  51
Lipase increased  1  1/45 (2.22%)  2
Lymphocyte count decreased  1  45/45 (100.00%)  438
Lymphocyte count increased  1  1/45 (2.22%)  1
Neutrophil count decreased  1  35/45 (77.78%)  207
Platelet count decreased  1  42/45 (93.33%)  214
Serum amylase increased  1  1/45 (2.22%)  1
Weight loss  1  1/45 (2.22%)  1
White blood cell decreased  1  38/45 (84.44%)  284
Metabolism and nutrition disorders   
Anorexia  1  5/45 (11.11%)  7
Dehydration  1  4/45 (8.89%)  5
Hypercalcemia  1  10/45 (22.22%)  18
Hyperglycemia  1  3/45 (6.67%)  3
Hyperkalemia  1  9/45 (20.00%)  12
Hypermagnesemia  1  23/45 (51.11%)  35
Hypernatremia  1  26/45 (57.78%)  52
Hyperuricemia  1  12/45 (26.67%)  25
Hypoalbuminemia  1  42/45 (93.33%)  136
Hypocalcemia  1  20/45 (44.44%)  36
Hypokalemia  1  10/45 (22.22%)  19
Hypomagnesemia  1  17/45 (37.78%)  40
Hyponatremia  1  16/45 (35.56%)  33
Hypophosphatemia  1  29/45 (64.44%)  79
Musculoskeletal and connective tissue disorders   
Arthralgia  1  10/45 (22.22%)  10
Back pain  1  7/45 (15.56%)  8
Bone pain  1  2/45 (4.44%)  2
Chest wall pain  1  11/45 (24.44%)  14
Muscle weakness lower limb  1  1/45 (2.22%)  1
Muscle weakness trunk  1  1/45 (2.22%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1 [3]  6/45 (13.33%)  9
Myalgia  1  14/45 (31.11%)  19
Neck pain  1  2/45 (4.44%)  2
Non-cardiac chest pain  1  1/45 (2.22%)  1
Pain in extremity  1  15/45 (33.33%)  17
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [4]  2/45 (4.44%)  2
Nervous system disorders   
Cognitive disturbance  1  4/45 (8.89%)  4
Concentration impairment  1  2/45 (4.44%)  2
Dizziness  1  4/45 (8.89%)  4
Dysarthria  1  1/45 (2.22%)  1
Dysesthesia  1  1/45 (2.22%)  1
Dysgeusia  1  9/45 (20.00%)  10
Headache  1  15/45 (33.33%)  21
Memory impairment  1  2/45 (4.44%)  2
Nervous system disorders - Other, specify  1  1/45 (2.22%)  1
Paresthesia  1  1/45 (2.22%)  1
Peripheral motor neuropathy  1  1/45 (2.22%)  1
Peripheral sensory neuropathy  1  22/45 (48.89%)  33
Presyncope  1  2/45 (4.44%)  2
Somnolence  1  1/45 (2.22%)  1
Syncope  1  1/45 (2.22%)  1
Tremor  1  9/45 (20.00%)  11
Psychiatric disorders   
Agitation  1  1/45 (2.22%)  1
Anxiety  1  3/45 (6.67%)  5
Confusion  1  1/45 (2.22%)  1
Depression  1  3/45 (6.67%)  3
Insomnia  1  26/45 (57.78%)  30
Libido decreased  1  1/45 (2.22%)  2
Personality change  1  1/45 (2.22%)  1
Psychiatric disorders - Other, Emotional lability  1  1/45 (2.22%)  1
Suicidal ideation  1  1/45 (2.22%)  1
Renal and urinary disorders   
Cystitis noninfective  1  1/45 (2.22%)  1
Nocturia  1  1/45 (2.22%)  1
Urinary frequency  1  2/45 (4.44%)  2
Urinary incontinence  1  1/45 (2.22%)  1
Urinary retention  1  1/45 (2.22%)  1
Reproductive system and breast disorders   
Ejaculation disorder  1  1/45 (2.22%)  1
Erectile dysfunction  1  1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  3/45 (6.67%)  3
Bronchospasm  1  1/45 (2.22%)  1
Cough  1  9/45 (20.00%)  12
Dyspnea  1  20/45 (44.44%)  37
Epistaxis  1  1/45 (2.22%)  1
Hiccups  1  2/45 (4.44%)  3
Hoarseness  1  6/45 (13.33%)  6
Nasal congestion  1  3/45 (6.67%)  3
Pericardial effusion  1  1/45 (2.22%)  1
Pleural effusion  1  4/45 (8.89%)  4
Pleuritic pain  1  1/45 (2.22%)  1
Postnasal drip  1  1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders - Other, Rhinorrhea; Rt. Pleural density  1  2/45 (4.44%)  2
Sore throat  1  3/45 (6.67%)  4
Upper respiratory infection  1  30/45 (66.67%)  47
Skin and subcutaneous tissue disorders   
Dry skin  1  3/45 (6.67%)  3
Hyperhidrosis  1  1/45 (2.22%)  1
Nail discoloration  1  2/45 (4.44%)  2
Pruritus  1  6/45 (13.33%)  8
Rash acneiform  1  2/45 (4.44%)  3
Rash maculo-papular  1  27/45 (60.00%)  68
Skin and subcutaneous tissue disorders - Other, specify  1 [5]  5/45 (11.11%)  5
Skin hyperpigmentation  1  1/45 (2.22%)  1
Skin ulceration  1  2/45 (4.44%)  2
Vascular disorders   
Hematoma  1  2/45 (4.44%)  2
Hot flashes  1  6/45 (13.33%)  7
Hypertension  1  5/45 (11.11%)  16
Hypotension  1  2/45 (4.44%)  3
Phlebitis  1  2/45 (4.44%)  2
Superficial thrombophlebitis  1  3/45 (6.67%)  3
Thromboembolic event  1  5/45 (11.11%)  6
Vascular disorders - Other, Raynaud's disorder  1  1/45 (2.22%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Diminished visual; diplopia; visual changes; conjunctival bleeding L eye; increased intraocular pressure; scleral redness
[2]
Cellulitis' cellulitis L. ankle; flu; zoster
[3]
Achilles; bursitis; cramps/hands; cramps/legs; leg cramps; R rotator cuff tear; trigger finger R hand; umbilical hernia repair
[4]
BCC; papillary urothelial neoplasm
[5]
L. foot ruddy and taut; scalp sensitivity; skin lesion RLE; squamous cell skin cancer L thigh; sunburn
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dickran Kazandijian
Organization: National Cancer Institute
Phone: 301-480-8870
EMail: kazandijiandg@mail.nih.gov
Layout table for additonal information
Responsible Party: Dickran Kazandjian, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01402284     History of Changes
Other Study ID Numbers: 110221
11-C-0221
First Submitted: July 23, 2011
First Posted: July 26, 2011
Results First Submitted: March 1, 2017
Results First Posted: May 16, 2017
Last Update Posted: May 7, 2019