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Trial record 65 of 182 for:    carfilzomib OR pr-171

Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01080391
Recruitment Status : Completed
First Posted : March 4, 2010
Results First Posted : July 8, 2015
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsed Multiple Myeloma
Interventions Drug: Dexamethasone
Drug: Lenalidomide
Drug: Carfilzomib
Enrollment 792
Recruitment Details Participants were enrolled from 14 July 2010 to 15 March 2012. The primary analysis was conducted using a data cut-off date of 16 June 2014 and the final safety analysis after last subject last visit date (05 December 2017).
Pre-assignment Details Eligible participants were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by β2 microglobulin level (< vs. ≥ 2.5 mg/L), prior bortezomib exposure (no vs. yes), and prior lenalidomide exposure (no vs. yes).
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Hide Arm/Group Description Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22. Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
Period Title: Overall Study
Started 396 396
Treated 389 392
Completed [1] 389 392
Not Completed 7 4
Reason Not Completed
Randomized but not treated             7             4
[1]
Completed represents patients who discontinued treatment as of 05 December 2017
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Total
Hide Arm/Group Description Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22. Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle. Total of all reporting groups
Overall Number of Baseline Participants 396 396 792
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 396 participants 396 participants 792 participants
64.5  (9.04) 63.3  (9.21) 63.9  (9.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 396 participants 792 participants
Female
164
  41.4%
181
  45.7%
345
  43.6%
Male
232
  58.6%
215
  54.3%
447
  56.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 396 participants 792 participants
American Indian or Alaska Native
1
   0.3%
0
   0.0%
1
   0.1%
Asian/Native Hawaiian or Pacific Islander
3
   0.8%
1
   0.3%
4
   0.5%
Black or African American
11
   2.8%
12
   3.0%
23
   2.9%
White
377
  95.2%
377
  95.2%
754
  95.2%
Other
4
   1.0%
6
   1.5%
10
   1.3%
Serum β2 Microglobulin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 396 participants 792 participants
< 2.5 mg/L
77
  19.4%
77
  19.4%
154
  19.4%
≥ 2.5 mg/L
319
  80.6%
319
  80.6%
638
  80.6%
Prior Bortezomib Exposure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 396 participants 792 participants
Yes
261
  65.9%
261
  65.9%
522
  65.9%
No
135
  34.1%
135
  34.1%
270
  34.1%
Prior Lenalidomide Exposure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 396 participants 792 participants
Yes
78
  19.7%
80
  20.2%
158
  19.9%
No
318
  80.3%
316
  79.8%
634
  80.1%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).
Time Frame From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set comprised of all randomized participants
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Hide Arm/Group Description:
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
Overall Number of Participants Analyzed 396 396
Median (95% Confidence Interval)
Unit of Measure: months
17.6
(15.0 to 20.6)
26.3
(23.3 to 30.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide and Dexamethasone (Rd), Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analysis was stratified by β2 microglobulin levels (< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes)
Method Log Rank
Comments The stopping boundary for this analysis was 0.0127 based on 1-sided significance level (O’Brien-Fleming with Lan-DeMets spending function).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.690
Confidence Interval (2-Sided) 95%
0.570 to 0.834
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.
Time Frame From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set comprised of all randomized participants
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Hide Arm/Group Description:
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
Overall Number of Participants Analyzed 396 396
Median (95% Confidence Interval)
Unit of Measure: months
40.4
(33.6 to 44.4)
48.3
(42.4 to 52.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide and Dexamethasone (Rd), Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Comments The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).
Type of Statistical Test Superiority
Comments The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O’Brien-Fleming with Lan-DeMets spending function).
Statistical Test of Hypothesis P-Value 0.0045
Comments [Not Specified]
Method Log Rank
Comments Analysis was stratified by β2 microglobulin levels (< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.794
Confidence Interval (2-Sided) 95%
0.667 to 0.945
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Response Rate
Hide Description Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).
Time Frame From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set comprised of all randomized participants
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Hide Arm/Group Description:
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
Overall Number of Participants Analyzed 396 396
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.7
(61.8 to 71.3)
87.1
(83.4 to 90.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide and Dexamethasone (Rd), Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel Haenszel chi-square test
Comments Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.472
Confidence Interval (2-Sided) 95%
2.411 to 5.001
Estimation Comments The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.
4.Secondary Outcome
Title Disease Control Rate
Hide Description Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).
Time Frame From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set comprised of all randomized participants
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Hide Arm/Group Description:
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
Overall Number of Participants Analyzed 396 396
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.1
(83.4 to 90.3)
92.7
(89.7 to 95.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide and Dexamethasone (Rd), Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0044
Comments [Not Specified]
Method Cochran-Mantel Haenszel chi-square test
Comments Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.897
Confidence Interval (2-Sided) 95%
1.17 to 3.08
Estimation Comments The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
Time Frame From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to treat (ITT) population with participantant who achieved a best overall response of PR or better.
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Hide Arm/Group Description:
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
Overall Number of Participants Analyzed 264 345
Median (95% Confidence Interval)
Unit of Measure: months
21.2
(16.7 to 25.8)
28.6
(24.9 to 31.3)
6.Secondary Outcome
Title Duration of Disease Control
Hide Description Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
Time Frame From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to treat (ITT) population with participantants who achieved disease control.
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Hide Arm/Group Description:
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
Overall Number of Participants Analyzed 345 367
Median (95% Confidence Interval)
Unit of Measure: months
18.9
(16.6 to 22.2)
28.7
(24.4 to 31.6)
7.Secondary Outcome
Title Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Hide Description Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.
Time Frame Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set participants with a baseline value.
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Hide Arm/Group Description:
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
Overall Number of Participants Analyzed 367 375
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 Day 1 (Baseline) Number Analyzed 367 participants 375 participants
58.1  (21.7) 58.3  (21.7)
Cycle 3, Day 1 Number Analyzed 334 participants 356 participants
56.8  (19.4) 59.9  (20.4)
Cycle 6, Day 1 Number Analyzed 284 participants 326 participants
58.9  (19.7) 62.5  (20.1)
Cycle 12, Day 1 Number Analyzed 212 participants 255 participants
57.3  (19.7) 62.7  (19.6)
Cycle 18, Day 1 Number Analyzed 147 participants 226 participants
59.9  (18.8) 64.3  (19.2)
Time Frame From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Hide Arm/Group Description Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22. Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
All-Cause Mortality
Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Affected / at Risk (%) Affected / at Risk (%)
Total   221/389 (56.81%)   256/392 (65.31%) 
Blood and lymphatic system disorders     
Anaemia  1  10/389 (2.57%)  8/392 (2.04%) 
Bone marrow failure  1  1/389 (0.26%)  0/392 (0.00%) 
Febrile neutropenia  1  4/389 (1.03%)  8/392 (2.04%) 
Haemolytic anaemia  1  1/389 (0.26%)  1/392 (0.26%) 
Leukopenia  1  1/389 (0.26%)  1/392 (0.26%) 
Neutropenia  1  5/389 (1.29%)  4/392 (1.02%) 
Pancytopenia  1  1/389 (0.26%)  0/392 (0.00%) 
Platelet disorder  1  1/389 (0.26%)  0/392 (0.00%) 
Thrombocytopenia  1  4/389 (1.03%)  5/392 (1.28%) 
Cardiac disorders     
Acute coronary syndrome  1  1/389 (0.26%)  0/392 (0.00%) 
Acute myocardial infarction  1  1/389 (0.26%)  5/392 (1.28%) 
Angina pectoris  1  4/389 (1.03%)  2/392 (0.51%) 
Angina unstable  1  1/389 (0.26%)  0/392 (0.00%) 
Arrhythmia  1  1/389 (0.26%)  1/392 (0.26%) 
Atrial fibrillation  1  8/389 (2.06%)  9/392 (2.30%) 
Atrial flutter  1  1/389 (0.26%)  1/392 (0.26%) 
Atrial tachycardia  1  0/389 (0.00%)  1/392 (0.26%) 
Atrioventricular block complete  1  0/389 (0.00%)  1/392 (0.26%) 
Bradycardia  1  1/389 (0.26%)  1/392 (0.26%) 
Cardiac arrest  1  1/389 (0.26%)  2/392 (0.51%) 
Cardiac failure  1  3/389 (0.77%)  5/392 (1.28%) 
Cardiac failure acute  1  0/389 (0.00%)  1/392 (0.26%) 
Cardiac failure congestive  1  3/389 (0.77%)  5/392 (1.28%) 
Cardiopulmonary failure  1  1/389 (0.26%)  1/392 (0.26%) 
Coronary artery disease  1  0/389 (0.00%)  1/392 (0.26%) 
Coronary artery occlusion  1  0/389 (0.00%)  2/392 (0.51%) 
Coronary artery stenosis  1  1/389 (0.26%)  0/392 (0.00%) 
Left ventricular dysfunction  1  0/389 (0.00%)  2/392 (0.51%) 
Mitral valve incompetence  1  0/389 (0.00%)  1/392 (0.26%) 
Myocardial infarction  1  3/389 (0.77%)  6/392 (1.53%) 
Myocardial ischaemia  1  0/389 (0.00%)  2/392 (0.51%) 
Pericardial effusion  1  0/389 (0.00%)  1/392 (0.26%) 
Stress cardiomyopathy  1  0/389 (0.00%)  1/392 (0.26%) 
Tachycardia  1  0/389 (0.00%)  1/392 (0.26%) 
Ventricular arrhythmia  1  0/389 (0.00%)  1/392 (0.26%) 
Ventricular tachycardia  1  0/389 (0.00%)  1/392 (0.26%) 
Aortic valve stenosis  1  1/389 (0.26%)  0/392 (0.00%) 
Bradyarrhythmia  1  0/389 (0.00%)  1/392 (0.26%) 
Cardiac asthma  1  0/389 (0.00%)  1/392 (0.26%) 
Supraventricular tachycardia  1  1/389 (0.26%)  0/392 (0.00%) 
Left ventricular failure  1  1/389 (0.26%)  0/392 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/389 (0.26%)  0/392 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  2/389 (0.51%)  0/392 (0.00%) 
Hypothyroidism  1  1/389 (0.26%)  0/392 (0.00%) 
Eye disorders     
Cataract  1  1/389 (0.26%)  5/392 (1.28%) 
Cataract nuclear  1  1/389 (0.26%)  0/392 (0.00%) 
Cataract subcapsular  1  1/389 (0.26%)  0/392 (0.00%) 
Retinal vein occlusion  1  1/389 (0.26%)  0/392 (0.00%) 
Retinal detachment  1  0/389 (0.00%)  1/392 (0.26%) 
Gastrointestinal disorders     
Abdominal hernia obstructive  1  0/389 (0.00%)  1/392 (0.26%) 
Abdominal pain  1  3/389 (0.77%)  4/392 (1.02%) 
Abdominal pain upper  1  1/389 (0.26%)  0/392 (0.00%) 
Colitis  1  0/389 (0.00%)  1/392 (0.26%) 
Constipation  1  1/389 (0.26%)  0/392 (0.00%) 
Dental caries  1  1/389 (0.26%)  0/392 (0.00%) 
Diarrhoea  1  9/389 (2.31%)  7/392 (1.79%) 
Diverticular perforation  1  0/389 (0.00%)  2/392 (0.51%) 
Diverticulum oesophageal  1  0/389 (0.00%)  1/392 (0.26%) 
Duodenal stenosis  1  0/389 (0.00%)  1/392 (0.26%) 
Enteritis  1  1/389 (0.26%)  0/392 (0.00%) 
Gastrointestinal haemorrhage  1  2/389 (0.51%)  0/392 (0.00%) 
Gastrooesophageal reflux disease  1  1/389 (0.26%)  0/392 (0.00%) 
Ileus  1  0/389 (0.00%)  1/392 (0.26%) 
Impaired gastric emptying  1  1/389 (0.26%)  0/392 (0.00%) 
Intestinal obstruction  1  1/389 (0.26%)  1/392 (0.26%) 
Large intestine perforation  1  0/389 (0.00%)  2/392 (0.51%) 
Lower gastrointestinal haemorrhage  1  0/389 (0.00%)  1/392 (0.26%) 
Nausea  1  1/389 (0.26%)  0/392 (0.00%) 
Neutropenic colitis  1  0/389 (0.00%)  1/392 (0.26%) 
Pancreatitis acute  1  0/389 (0.00%)  2/392 (0.51%) 
Small intestinal obstruction  1  1/389 (0.26%)  0/392 (0.00%) 
Small intestinal perforation  1  1/389 (0.26%)  0/392 (0.00%) 
Vomiting  1  2/389 (0.51%)  0/392 (0.00%) 
Duodenal ulcer  1  0/389 (0.00%)  1/392 (0.26%) 
Umbilical hernia  1  0/389 (0.00%)  1/392 (0.26%) 
General disorders     
Asthenia  1  0/389 (0.00%)  2/392 (0.51%) 
Chest pain  1  1/389 (0.26%)  1/392 (0.26%) 
Death  1  2/389 (0.51%)  2/392 (0.51%) 
Disease progression  1  8/389 (2.06%)  4/392 (1.02%) 
Fatigue  1  0/389 (0.00%)  1/392 (0.26%) 
General physical health deterioration  1  4/389 (1.03%)  0/392 (0.00%) 
Influenza like illness  1  0/389 (0.00%)  1/392 (0.26%) 
Malaise  1  1/389 (0.26%)  1/392 (0.26%) 
Mucosal inflammation  1  1/389 (0.26%)  0/392 (0.00%) 
Multi-organ failure  1  1/389 (0.26%)  2/392 (0.51%) 
Non-cardiac chest pain  1  0/389 (0.00%)  2/392 (0.51%) 
Pyrexia  1  9/389 (2.31%)  14/392 (3.57%) 
Sudden death  1  1/389 (0.26%)  1/392 (0.26%) 
Systemic inflammatory response syndrome  1  0/389 (0.00%)  1/392 (0.26%) 
Disease progression  1  8/389 (2.06%)  5/392 (1.28%) 
Drowning  1  0/389 (0.00%)  1/392 (0.26%) 
Fatigue  1  1/389 (0.26%)  1/392 (0.26%) 
General physical health deterioration  1  4/389 (1.03%)  2/392 (0.51%) 
Multiple organ dysfunction syndrome  1  1/389 (0.26%)  2/392 (0.51%) 
Non-cardiac chest pain  1  0/389 (0.00%)  3/392 (0.77%) 
Pyrexia  1  12/389 (3.08%)  15/392 (3.83%) 
Hepatobiliary disorders     
Bile duct stone  1  0/389 (0.00%)  1/392 (0.26%) 
Cholangitis  1  0/389 (0.00%)  2/392 (0.51%) 
Cholecystitis  1  2/389 (0.51%)  0/392 (0.00%) 
Cholecystitis acute  1  3/389 (0.77%)  4/392 (1.02%) 
Cholelithiasis  1  1/389 (0.26%)  2/392 (0.51%) 
Hepatitis toxic  1  0/389 (0.00%)  1/392 (0.26%) 
Hepatotoxicity  1  1/389 (0.26%)  0/392 (0.00%) 
Hepatic cirrhosis  1  0/389 (0.00%)  1/392 (0.26%) 
Immune system disorders     
Cytokine release syndrome  1  1/389 (0.26%)  0/392 (0.00%) 
Drug hypersensitivity  1  0/389 (0.00%)  1/392 (0.26%) 
Infections and infestations     
Abdominal abscess  1  0/389 (0.00%)  1/392 (0.26%) 
Bacteraemia  1  0/389 (0.00%)  2/392 (0.51%) 
Bacterial infection  1  0/389 (0.00%)  1/392 (0.26%) 
Bronchiolitis  1  1/389 (0.26%)  1/392 (0.26%) 
Bronchitis  1  11/389 (2.83%)  9/392 (2.30%) 
Bronchitis viral  1  1/389 (0.26%)  0/392 (0.00%) 
Bronchopneumonia  1  7/389 (1.80%)  5/392 (1.28%) 
Bronchopulmonary aspergillosis  1  1/389 (0.26%)  0/392 (0.00%) 
Catheter site cellulitis  1  0/389 (0.00%)  1/392 (0.26%) 
Cellulitis  1  4/389 (1.03%)  1/392 (0.26%) 
Cholangitis suppurative  1  0/389 (0.00%)  1/392 (0.26%) 
Chronic hepatitis C  1  0/389 (0.00%)  1/392 (0.26%) 
Clostridial infection  1  0/389 (0.00%)  2/392 (0.51%) 
Clostridium difficile colitis  1  0/389 (0.00%)  4/392 (1.02%) 
Cystitis  1  1/389 (0.26%)  0/392 (0.00%) 
Device related infection  1  1/389 (0.26%)  3/392 (0.77%) 
Diverticulitis  1  1/389 (0.26%)  1/392 (0.26%) 
Endocarditis  1  0/389 (0.00%)  2/392 (0.51%) 
Enterocolitis bacterial  1  0/389 (0.00%)  1/392 (0.26%) 
Erysipelas  1  1/389 (0.26%)  1/392 (0.26%) 
Escherichia sepsis  1  0/389 (0.00%)  1/392 (0.26%) 
Escherichia urinary tract infection  1  0/389 (0.00%)  1/392 (0.26%) 
Gastroenteritis  1  5/389 (1.29%)  5/392 (1.28%) 
Genitourinary tract infection  1  1/389 (0.26%)  0/392 (0.00%) 
Gingivitis  1  0/389 (0.00%)  1/392 (0.26%) 
Hepatic infection  1  1/389 (0.26%)  0/392 (0.00%) 
Herpes zoster disseminated  1  1/389 (0.26%)  1/392 (0.26%) 
Incision site infection  1  0/389 (0.00%)  1/392 (0.26%) 
Infection  1  1/389 (0.26%)  1/392 (0.26%) 
Influenza  1  2/389 (0.51%)  3/392 (0.77%) 
Laryngitis bacterial  1  0/389 (0.00%)  1/392 (0.26%) 
Listeria sepsis  1  1/389 (0.26%)  0/392 (0.00%) 
Liver abscess  1  0/389 (0.00%)  1/392 (0.26%) 
Lobar pneumonia  1  1/389 (0.26%)  2/392 (0.51%) 
Lower respiratory tract infection  1  3/389 (0.77%)  2/392 (0.51%) 
Lower respiratory tract infection viral  1  1/389 (0.26%)  0/392 (0.00%) 
Lung infection  1  1/389 (0.26%)  3/392 (0.77%) 
Neutropenic sepsis  1  0/389 (0.00%)  1/392 (0.26%) 
Peritonitis  1  0/389 (0.00%)  1/392 (0.26%) 
Pneumocystis jiroveci pneumonia  1  0/389 (0.00%)  1/392 (0.26%) 
Pneumonia  1  52/389 (13.37%)  67/392 (17.09%) 
Pneumonia bacterial  1  3/389 (0.77%)  0/392 (0.00%) 
Pneumonia influenzal  1  0/389 (0.00%)  1/392 (0.26%) 
Pneumonia respiratory syncytial viral  1  1/389 (0.26%)  1/392 (0.26%) 
Pneumonia viral  1  1/389 (0.26%)  0/392 (0.00%) 
Postoperative abscess  1  1/389 (0.26%)  0/392 (0.00%) 
Pulmonary sepsis  1  1/389 (0.26%)  0/392 (0.00%) 
Pyelonephritis acute  1  1/389 (0.26%)  0/392 (0.00%) 
Respiratory syncytial virus bronchiolitis  1  0/389 (0.00%)  1/392 (0.26%) 
Respiratory syncytial virus infection  1  1/389 (0.26%)  0/392 (0.00%) 
Respiratory tract infection  1  8/389 (2.06%)  16/392 (4.08%) 
Respiratory tract infection viral  1  2/389 (0.51%)  1/392 (0.26%) 
Salmonella sepsis  1  0/389 (0.00%)  1/392 (0.26%) 
Sepsis  1  5/389 (1.29%)  7/392 (1.79%) 
Sepsis syndrome  1  0/389 (0.00%)  1/392 (0.26%) 
Septic shock  1  4/389 (1.03%)  3/392 (0.77%) 
Sinusitis  1  2/389 (0.51%)  4/392 (1.02%) 
Staphylococcal bacteraemia  1  0/389 (0.00%)  1/392 (0.26%) 
Streptococcal bacteraemia  1  1/389 (0.26%)  1/392 (0.26%) 
Testicular abscess  1  0/389 (0.00%)  1/392 (0.26%) 
Tonsillitis  1  1/389 (0.26%)  0/392 (0.00%) 
Tooth abscess  1  1/389 (0.26%)  0/392 (0.00%) 
Tracheobronchitis  1  0/389 (0.00%)  2/392 (0.51%) 
Tuberculosis  1  1/389 (0.26%)  0/392 (0.00%) 
Upper respiratory tract infection  1  0/389 (0.00%)  4/392 (1.02%) 
Urinary tract infection  1  2/389 (0.51%)  4/392 (1.02%) 
Urosepsis  1  2/389 (0.51%)  1/392 (0.26%) 
Arthritis infective  1  1/389 (0.26%)  0/392 (0.00%) 
Atypical pneumonia  1  0/389 (0.00%)  1/392 (0.26%) 
Cholangitis infective  1  0/389 (0.00%)  1/392 (0.26%) 
Clostridium difficile infection  1  0/389 (0.00%)  2/392 (0.51%) 
Epididymitis  1  0/389 (0.00%)  1/392 (0.26%) 
Gastroenteritis salmonella  1  0/389 (0.00%)  1/392 (0.26%) 
Hepatitis B  1  0/389 (0.00%)  1/392 (0.26%) 
Osteomyelitis  1  0/389 (0.00%)  1/392 (0.26%) 
Osteomyelitis bacterial  1  1/389 (0.26%)  0/392 (0.00%) 
Pneumocystis jirovecii pneumonia  1  0/389 (0.00%)  1/392 (0.26%) 
Progressive multifocal leukoencephalopathy  1  1/389 (0.26%)  0/392 (0.00%) 
Staphylococcal infection  1  0/389 (0.00%)  1/392 (0.26%) 
Staphylococcal sepsis  1  1/389 (0.26%)  0/392 (0.00%) 
Stoma site abscess  1  0/389 (0.00%)  1/392 (0.26%) 
Postoperative wound infection  1  0/389 (0.00%)  1/392 (0.26%) 
Injury, poisoning and procedural complications     
Concussion  1  0/389 (0.00%)  1/392 (0.26%) 
Contusion  1  1/389 (0.26%)  0/392 (0.00%) 
Fall  1  2/389 (0.51%)  1/392 (0.26%) 
Femoral neck fracture  1  1/389 (0.26%)  0/392 (0.00%) 
Femur fracture  1  3/389 (0.77%)  5/392 (1.28%) 
Fibula fracture  1  0/389 (0.00%)  2/392 (0.51%) 
Gallbladder injury  1  0/389 (0.00%)  1/392 (0.26%) 
Hip fracture  1  3/389 (0.77%)  1/392 (0.26%) 
Jaw fracture  1  1/389 (0.26%)  0/392 (0.00%) 
Joint dislocation  1  1/389 (0.26%)  0/392 (0.00%) 
Lumbar vertebral fracture  1  2/389 (0.51%)  1/392 (0.26%) 
Multiple fractures  1  1/389 (0.26%)  0/392 (0.00%) 
Road traffic accident  1  0/389 (0.00%)  2/392 (0.51%) 
Spinal compression fracture  1  1/389 (0.26%)  1/392 (0.26%) 
Splenic injury  1  1/389 (0.26%)  0/392 (0.00%) 
Stress fracture  1  1/389 (0.26%)  0/392 (0.00%) 
Subdural haematoma  1  1/389 (0.26%)  1/392 (0.26%) 
Traumatic fracture  1  0/389 (0.00%)  2/392 (0.51%) 
Facial bones fracture  1  0/389 (0.00%)  1/392 (0.26%) 
Humerus fracture  1  0/389 (0.00%)  1/392 (0.26%) 
Ligament sprain  1  0/389 (0.00%)  1/392 (0.26%) 
Pubis fracture  1  0/389 (0.00%)  1/392 (0.26%) 
Investigations     
Alanine aminotransferase increased  1  0/389 (0.00%)  1/392 (0.26%) 
Blood creatinine increased  1  1/389 (0.26%)  1/392 (0.26%) 
Cardiac stress test abnormal  1  0/389 (0.00%)  1/392 (0.26%) 
General physical condition abnormal  1  1/389 (0.26%)  0/392 (0.00%) 
Haemoglobin decreased  1  0/389 (0.00%)  1/392 (0.26%) 
Influenza A virus test positive  1  0/389 (0.00%)  2/392 (0.51%) 
Intraocular pressure increased  1  0/389 (0.00%)  1/392 (0.26%) 
Monoclonal immunoglobulin present  1  0/389 (0.00%)  1/392 (0.26%) 
Respiratory syncytial virus test positive  1  0/389 (0.00%)  1/392 (0.26%) 
Streptococcus test positive  1  0/389 (0.00%)  1/392 (0.26%) 
Viral test positive  1  1/389 (0.26%)  0/392 (0.00%) 
Weight decreased  1  0/389 (0.00%)  1/392 (0.26%) 
Metabolism and nutrition disorders     
Dehydration  1  1/389 (0.26%)  0/392 (0.00%) 
Diabetes mellitus  1  1/389 (0.26%)  0/392 (0.00%) 
Diabetic ketoacidosis  1  0/389 (0.00%)  1/392 (0.26%) 
Electrolyte imbalance  1  1/389 (0.26%)  1/392 (0.26%) 
Fluid overload  1  0/389 (0.00%)  1/392 (0.26%) 
Gout  1  1/389 (0.26%)  0/392 (0.00%) 
Hypercalcaemia  1  3/389 (0.77%)  0/392 (0.00%) 
Hyperglycaemia  1  0/389 (0.00%)  3/392 (0.77%) 
Hypoalbuminaemia  1  0/389 (0.00%)  1/392 (0.26%) 
Hypocalcaemia  1  0/389 (0.00%)  2/392 (0.51%) 
Hypokalaemia  1  1/389 (0.26%)  2/392 (0.51%) 
Hyponatraemia  1  2/389 (0.51%)  1/392 (0.26%) 
Mineral deficiency  1  1/389 (0.26%)  0/392 (0.00%) 
Tumour lysis syndrome  1  0/389 (0.00%)  3/392 (0.77%) 
Type 2 diabetes mellitus  1  1/389 (0.26%)  0/392 (0.00%) 
Hypoglycaemia  1  0/389 (0.00%)  1/392 (0.26%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/389 (0.26%)  1/392 (0.26%) 
Arthritis  1  0/389 (0.00%)  1/392 (0.26%) 
Back pain  1  4/389 (1.03%)  2/392 (0.51%) 
Bone pain  1  1/389 (0.26%)  1/392 (0.26%) 
Chondrocalcinosis pyrophosphate  1  1/389 (0.26%)  0/392 (0.00%) 
Flank pain  1  0/389 (0.00%)  1/392 (0.26%) 
Fracture pain  1  1/389 (0.26%)  0/392 (0.00%) 
Gouty arthritis  1  1/389 (0.26%)  0/392 (0.00%) 
Intervertebral disc compression  1  0/389 (0.00%)  1/392 (0.26%) 
Joint swelling  1  1/389 (0.26%)  0/392 (0.00%) 
Lumbar spinal stenosis  1  1/389 (0.26%)  0/392 (0.00%) 
Muscular weakness  1  1/389 (0.26%)  1/392 (0.26%) 
Musculoskeletal pain  1  1/389 (0.26%)  1/392 (0.26%) 
Neck pain  1  2/389 (0.51%)  0/392 (0.00%) 
Osteoarthritis  1  1/389 (0.26%)  0/392 (0.00%) 
Osteonecrosis  1  1/389 (0.26%)  1/392 (0.26%) 
Osteonecrosis of jaw  1  3/389 (0.77%)  2/392 (0.51%) 
Pain in extremity  1  1/389 (0.26%)  1/392 (0.26%) 
Pathological fracture  1  1/389 (0.26%)  2/392 (0.51%) 
Rotator cuff syndrome  1  0/389 (0.00%)  1/392 (0.26%) 
Spinal column stenosis  1  1/389 (0.26%)  0/392 (0.00%) 
Tenosynovitis  1  0/389 (0.00%)  1/392 (0.26%) 
Crystal arthropathy  1  0/389 (0.00%)  1/392 (0.26%) 
Spinal pain  1  1/389 (0.26%)  1/392 (0.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  2/389 (0.51%)  2/392 (0.51%) 
Adenocarcinoma pancreas  1  0/389 (0.00%)  1/392 (0.26%) 
Basal cell carcinoma  1  4/389 (1.03%)  5/392 (1.28%) 
Colon cancer  1  0/389 (0.00%)  2/392 (0.51%) 
Colorectal cancer  1  0/389 (0.00%)  1/392 (0.26%) 
Gastrointestinal neoplasm  1  1/389 (0.26%)  0/392 (0.00%) 
Gastrointestinal stromal tumour  1  1/389 (0.26%)  0/392 (0.00%) 
Hepatic neoplasm malignant  1  1/389 (0.26%)  0/392 (0.00%) 
Leukaemia plasmacytic  1  0/389 (0.00%)  1/392 (0.26%) 
Malignant melanoma  1  1/389 (0.26%)  0/392 (0.00%) 
Malignant neoplasm of pleura  1  0/389 (0.00%)  1/392 (0.26%) 
Multiple myeloma  1  2/389 (0.51%)  0/392 (0.00%) 
Myelodysplastic syndrome  1  4/389 (1.03%)  1/392 (0.26%) 
Non-small cell lung cancer  1  1/389 (0.26%)  0/392 (0.00%) 
Pancreatic carcinoma metastatic  1  0/389 (0.00%)  1/392 (0.26%) 
Pancreatic neoplasm  1  0/389 (0.00%)  1/392 (0.26%) 
Plasmacytoma  1  1/389 (0.26%)  2/392 (0.51%) 
Rectal cancer  1  1/389 (0.26%)  0/392 (0.00%) 
Squamous cell carcinoma  1  3/389 (0.77%)  2/392 (0.51%) 
Squamous cell carcinoma of skin  1  1/389 (0.26%)  2/392 (0.51%) 
Adenocarcinoma of colon  1  0/389 (0.00%)  1/392 (0.26%) 
B precursor type acute leukaemia  1  0/389 (0.00%)  1/392 (0.26%) 
Bowen's disease  1  1/389 (0.26%)  0/392 (0.00%) 
Glioblastoma  1  1/389 (0.26%)  0/392 (0.00%) 
Hepatic cancer  1  1/389 (0.26%)  0/392 (0.00%) 
Laryngeal cancer  1  0/389 (0.00%)  1/392 (0.26%) 
Lung adenocarcinoma  1  1/389 (0.26%)  0/392 (0.00%) 
Non-Hodgkin's lymphoma  1  1/389 (0.26%)  0/392 (0.00%) 
Plasma cell leukaemia  1  0/389 (0.00%)  1/392 (0.26%) 
Plasma cell myeloma  1  2/389 (0.51%)  0/392 (0.00%) 
Rectal adenocarcinoma  1  2/389 (0.51%)  0/392 (0.00%) 
Nervous system disorders     
Altered state of consciousness  1  0/389 (0.00%)  1/392 (0.26%) 
Amyotrophic lateral sclerosis  1  1/389 (0.26%)  0/392 (0.00%) 
Cauda equina syndrome  1  0/389 (0.00%)  1/392 (0.26%) 
Cerebral cyst  1  0/389 (0.00%)  1/392 (0.26%) 
Cerebral haemorrhage  1  1/389 (0.26%)  0/392 (0.00%) 
Cerebrovascular accident  1  10/389 (2.57%)  4/392 (1.02%) 
Cognitive disorder  1  0/389 (0.00%)  1/392 (0.26%) 
Coma  1  1/389 (0.26%)  0/392 (0.00%) 
Convulsion  1  2/389 (0.51%)  0/392 (0.00%) 
Haemorrhage intracranial  1  0/389 (0.00%)  1/392 (0.26%) 
Headache  1  0/389 (0.00%)  2/392 (0.51%) 
Hydrocephalus  1  0/389 (0.00%)  1/392 (0.26%) 
Loss of consciousness  1  0/389 (0.00%)  1/392 (0.26%) 
Myxoedema coma  1  1/389 (0.26%)  0/392 (0.00%) 
Neuralgia  1  1/389 (0.26%)  0/392 (0.00%) 
Paraparesis  1  0/389 (0.00%)  1/392 (0.26%) 
Polyneuropathy  1  1/389 (0.26%)  0/392 (0.00%) 
Spinal cord compression  1  3/389 (0.77%)  2/392 (0.51%) 
Syncope  1  2/389 (0.51%)  3/392 (0.77%) 
Transient ischaemic attack  1  3/389 (0.77%)  0/392 (0.00%) 
VIth nerve paralysis  1  1/389 (0.26%)  0/392 (0.00%) 
Cerebral ischaemia  1  0/389 (0.00%)  1/392 (0.26%) 
Guillain-Barre syndrome  1  0/389 (0.00%)  1/392 (0.26%) 
Ischaemic cerebral infarction  1  0/389 (0.00%)  1/392 (0.26%) 
Ischaemic stroke  1  0/389 (0.00%)  1/392 (0.26%) 
Seizure  1  2/389 (0.51%)  0/392 (0.00%) 
Psychiatric disorders     
Completed suicide  1  0/389 (0.00%)  1/392 (0.26%) 
Confusional state  1  1/389 (0.26%)  1/392 (0.26%) 
Disorientation  1  0/389 (0.00%)  2/392 (0.51%) 
Mental status changes  1  1/389 (0.26%)  0/392 (0.00%) 
Personality change  1  0/389 (0.00%)  1/392 (0.26%) 
Psychiatric decompensation  1  0/389 (0.00%)  1/392 (0.26%) 
Renal and urinary disorders     
Haematuria  1  0/389 (0.00%)  1/392 (0.26%) 
Nephropathy  1  1/389 (0.26%)  0/392 (0.00%) 
Nephrotic syndrome  1  0/389 (0.00%)  1/392 (0.26%) 
Prerenal failure  1  1/389 (0.26%)  0/392 (0.00%) 
Renal failure  1  1/389 (0.26%)  1/392 (0.26%) 
Renal failure acute  1  4/389 (1.03%)  6/392 (1.53%) 
Renal failure chronic  1  1/389 (0.26%)  0/392 (0.00%) 
Renal impairment  1  1/389 (0.26%)  1/392 (0.26%) 
Urinary retention  1  1/389 (0.26%)  1/392 (0.26%) 
Acute kidney injury  1  4/389 (1.03%)  8/392 (2.04%) 
Chronic kidney disease  1  1/389 (0.26%)  0/392 (0.00%) 
Urethral prolapse  1  0/389 (0.00%)  1/392 (0.26%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/389 (0.00%)  1/392 (0.26%) 
Epididymitis  1  0/389 (0.00%)  1/392 (0.26%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/389 (0.00%)  4/392 (1.02%) 
Alveolitis  1  0/389 (0.00%)  1/392 (0.26%) 
Bronchitis chronic  1  0/389 (0.00%)  1/392 (0.26%) 
Bronchopneumopathy  1  0/389 (0.00%)  1/392 (0.26%) 
Bronchospasm  1  2/389 (0.51%)  0/392 (0.00%) 
Chronic obstructive pulmonary disease  1  1/389 (0.26%)  3/392 (0.77%) 
Dyspnoea  1  3/389 (0.77%)  4/392 (1.02%) 
Eosinophilic pneumonia  1  0/389 (0.00%)  1/392 (0.26%) 
Interstitial lung disease  1  1/389 (0.26%)  1/392 (0.26%) 
Lung disorder  1  4/389 (1.03%)  2/392 (0.51%) 
Pleural effusion  1  1/389 (0.26%)  1/392 (0.26%) 
Pleural fibrosis  1  0/389 (0.00%)  1/392 (0.26%) 
Pneumonia aspiration  1  0/389 (0.00%)  2/392 (0.51%) 
Pneumonitis  1  1/389 (0.26%)  1/392 (0.26%) 
Pulmonary embolism  1  8/389 (2.06%)  12/392 (3.06%) 
Pulmonary oedema  1  0/389 (0.00%)  4/392 (1.02%) 
Respiratory disorder  1  1/389 (0.26%)  0/392 (0.00%) 
Respiratory failure  1  4/389 (1.03%)  1/392 (0.26%) 
Laryngospasm  1  0/389 (0.00%)  1/392 (0.26%) 
Obstructive airways disorder  1  1/389 (0.26%)  0/392 (0.00%) 
Skin and subcutaneous tissue disorders     
Acute generalised exanthematous pustulosis  1  1/389 (0.26%)  0/392 (0.00%) 
Rash  1  1/389 (0.26%)  4/392 (1.02%) 
Vascular disorders     
Aortic aneurysm  1  0/389 (0.00%)  1/392 (0.26%) 
Circulatory collapse  1  0/389 (0.00%)  1/392 (0.26%) 
Deep vein thrombosis  1  6/389 (1.54%)  9/392 (2.30%) 
Embolism  1  0/389 (0.00%)  2/392 (0.51%) 
Haematoma  1  1/389 (0.26%)  0/392 (0.00%) 
Hypertension  1  1/389 (0.26%)  0/392 (0.00%) 
Hypotension  1  3/389 (0.77%)  2/392 (0.51%) 
Orthostatic hypotension  1  1/389 (0.26%)  0/392 (0.00%) 
Thrombophlebitis  1  0/389 (0.00%)  1/392 (0.26%) 
Thrombosis  1  0/389 (0.00%)  3/392 (0.77%) 
Vasculitis  1  1/389 (0.26%)  0/392 (0.00%) 
Venous thrombosis  1  1/389 (0.26%)  0/392 (0.00%) 
Peripheral ischaemia  1  1/389 (0.26%)  0/392 (0.00%) 
Venous thrombosis limb  1  1/389 (0.26%)  0/392 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide and Dexamethasone (Rd) Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Affected / at Risk (%) Affected / at Risk (%)
Total   358/389 (92.03%)   370/392 (94.39%) 
Blood and lymphatic system disorders     
Anaemia  1  154/389 (39.59%)  166/392 (42.35%) 
Leukopenia  1  22/389 (5.66%)  33/392 (8.42%) 
Neutropenia  1  133/389 (34.19%)  157/392 (40.05%) 
Thrombocytopenia  1  94/389 (24.16%)  115/392 (29.34%) 
Eye disorders     
Cataract  1  36/389 (9.25%)  39/392 (9.95%) 
Vision blurred  1  15/389 (3.86%)  24/392 (6.12%) 
Gastrointestinal disorders     
Abdominal pain  1  27/389 (6.94%)  32/392 (8.16%) 
Abdominal pain upper  1  12/389 (3.08%)  28/392 (7.14%) 
Constipation  1  69/389 (17.74%)  81/392 (20.66%) 
Diarrhoea  1  143/389 (36.76%)  170/392 (43.37%) 
Dyspepsia  1  22/389 (5.66%)  24/392 (6.12%) 
Nausea  1  57/389 (14.65%)  82/392 (20.92%) 
Vomiting  1  34/389 (8.74%)  49/392 (12.50%) 
Toothache  1  12/389 (3.08%)  20/392 (5.10%) 
General disorders     
Asthenia  1  56/389 (14.40%)  69/392 (17.60%) 
Chills  1  9/389 (2.31%)  25/392 (6.38%) 
Fatigue  1  119/389 (30.59%)  128/392 (32.65%) 
Oedema peripheral  1  75/389 (19.28%)  85/392 (21.68%) 
Pyrexia  1  78/389 (20.05%)  105/392 (26.79%) 
Asthenia  1  57/389 (14.65%)  72/392 (18.37%) 
Chills  1  9/389 (2.31%)  26/392 (6.63%) 
Fatigue  1  124/389 (31.88%)  132/392 (33.67%) 
Oedema peripheral  1  66/389 (16.97%)  78/392 (19.90%) 
Peripheral swelling  1  21/389 (5.40%)  21/392 (5.36%) 
Pyrexia  1  80/389 (20.57%)  110/392 (28.06%) 
Infections and infestations     
Bronchitis  1  56/389 (14.40%)  75/392 (19.13%) 
Influenza  1  14/389 (3.60%)  26/392 (6.63%) 
Nasopharyngitis  1  65/389 (16.71%)  87/392 (22.19%) 
Pneumonia  1  29/389 (7.46%)  45/392 (11.48%) 
Respiratory tract infection  1  39/389 (10.03%)  41/392 (10.46%) 
Sinusitis  1  18/389 (4.63%)  24/392 (6.12%) 
Upper respiratory tract infection  1  81/389 (20.82%)  115/392 (29.34%) 
Urinary tract infection  1  21/389 (5.40%)  36/392 (9.18%) 
Viral infection  1  11/389 (2.83%)  28/392 (7.14%) 
Viral upper respiratory tract infection  1  68/389 (17.48%)  80/392 (20.41%) 
Investigations     
Alanine aminotransferase increased  1  15/389 (3.86%)  21/392 (5.36%) 
Blood creatinine increased  1  21/389 (5.40%)  27/392 (6.89%) 
Neutrophil count decreased  1  22/389 (5.66%)  21/392 (5.36%) 
Weight decreased  1  20/389 (5.14%)  14/392 (3.57%) 
Metabolism and nutrition disorders     
Decreased appetite  1  35/389 (9.00%)  47/392 (11.99%) 
Hyperglycaemia  1  39/389 (10.03%)  48/392 (12.24%) 
Hypocalcaemia  1  49/389 (12.60%)  65/392 (16.58%) 
Hypokalaemia  1  58/389 (14.91%)  114/392 (29.08%) 
Hypomagnesaemia  1  29/389 (7.46%)  40/392 (10.20%) 
Hypophosphataemia  1  33/389 (8.48%)  57/392 (14.54%) 
Hyperuricaemia  1  11/389 (2.83%)  22/392 (5.61%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  57/389 (14.65%)  57/392 (14.54%) 
Back pain  1  81/389 (20.82%)  73/392 (18.62%) 
Bone pain  1  36/389 (9.25%)  39/392 (9.95%) 
Muscle spasms  1  82/389 (21.08%)  106/392 (27.04%) 
Muscular weakness  1  24/389 (6.17%)  28/392 (7.14%) 
Musculoskeletal chest pain  1  29/389 (7.46%)  26/392 (6.63%) 
Musculoskeletal pain  1  36/389 (9.25%)  25/392 (6.38%) 
Myalgia  1  22/389 (5.66%)  25/392 (6.38%) 
Pain in extremity  1  42/389 (10.80%)  48/392 (12.24%) 
Nervous system disorders     
Dizziness  1  45/389 (11.57%)  54/392 (13.78%) 
Dysgeusia  1  21/389 (5.40%)  14/392 (3.57%) 
Headache  1  32/389 (8.23%)  56/392 (14.29%) 
Neuropathy peripheral  1  28/389 (7.20%)  34/392 (8.67%) 
Paraesthesia  1  23/389 (5.91%)  27/392 (6.89%) 
Peripheral sensory neuropathy  1  27/389 (6.94%)  25/392 (6.38%) 
Tremor  1  32/389 (8.23%)  28/392 (7.14%) 
Psychiatric disorders     
Anxiety  1  17/389 (4.37%)  33/392 (8.42%) 
Insomnia  1  65/389 (16.71%)  81/392 (20.66%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  70/389 (17.99%)  116/392 (29.59%) 
Dyspnoea  1  59/389 (15.17%)  76/392 (19.39%) 
Dyspnoea exertional  1  19/389 (4.88%)  23/392 (5.87%) 
Oropharyngeal pain  1  22/389 (5.66%)  28/392 (7.14%) 
Epistaxis  1  17/389 (4.37%)  20/392 (5.10%) 
Productive cough  1  12/389 (3.08%)  21/392 (5.36%) 
Skin and subcutaneous tissue disorders     
Erythema  1  13/389 (3.34%)  30/392 (7.65%) 
Hyperhidrosis  1  18/389 (4.63%)  28/392 (7.14%) 
Pruritus  1  16/389 (4.11%)  31/392 (7.91%) 
Rash  1  59/389 (15.17%)  50/392 (12.76%) 
Vascular disorders     
Deep vein thrombosis  1  11/389 (2.83%)  21/392 (5.36%) 
Hypertension  1  30/389 (7.71%)  62/392 (15.82%) 
Hypotension  1  22/389 (5.66%)  26/392 (6.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Publications:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01080391     History of Changes
Other Study ID Numbers: PX-171-009
First Submitted: March 2, 2010
First Posted: March 4, 2010
Results First Submitted: June 8, 2015
Results First Posted: July 8, 2015
Last Update Posted: January 14, 2019