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Trial record 11 of 182 for:    carfilzomib OR pr-171

Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma

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: NCT00511238
Recruitment Status : Completed
First Posted : August 3, 2007
Results First Posted : December 9, 2013
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: carfilzomib
Enrollment 312
Recruitment Details Results of this study are reported in 2 parts, depending on whether a patient was enrolled and treated under the original protocol (referred to as ‘A0’) or under Amendment 1 and subsequent amendments (referred to as ‘A1’).
Pre-assignment Details  
Arm/Group Title Carfilzomib (A0) Carfilzomib (A1)
Hide Arm/Group Description Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
Period Title: Overall Study
Started 46 266
Completed 4 [1] 40 [1]
Not Completed 42 226
Reason Not Completed
Adverse Event             13             33
Withdrawal by Subject             2             22
Progressive Disease             23             157
various reasons             4             14
[1]
Number of patients who completed 12 cycles of treatment
Arm/Group Title Carfilzomib (A0) Carfilzomib (A1) Total
Hide Arm/Group Description Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. Total of all reporting groups
Overall Number of Baseline Participants 46 266 312
Hide Baseline Analysis Population Description
Safety population: The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 266 participants 312 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  56.5%
146
  54.9%
172
  55.1%
>=65 years
20
  43.5%
120
  45.1%
140
  44.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 266 participants 312 participants
Female
21
  45.7%
111
  41.7%
132
  42.3%
Male
25
  54.3%
155
  58.3%
180
  57.7%
1.Primary Outcome
Title Best Overall Response Rate (ORR)
Hide Description For both A0 and A1, to evaluate the best overall response rate (stringent complete response [sCR]+ complete response [CR]+ very good partial response [VGPR]+ partial response [PR]) in patients with multiple myeloma who had previously received bortezomib and either thalidomide or lenalidomide, had relapsed after two or more therapies, and were refractory to the most recently received therapy
Time Frame A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population described in reporting groups below
Arm/Group Title Carfilzomib (A0) Carfilzomib (A1)
Hide Arm/Group Description:

Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle

Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.

In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.

Response-Evaluable Population:

  1. had measurable disease at Baseline
  2. received at least 1 dose of carfilzomib
  3. underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib
Overall Number of Participants Analyzed 42 257
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of participants w/ PR or better
16.7
(6.97 to 31.36)
23.7
(18.67 to 29.42)
2.Secondary Outcome
Title Clinical Benefit Response (CBR) (A0 Only)
Hide Description sCR, CR, VGPR, PR, and minimal response (MR)
Time Frame Response assessments same as described in primary outcome measure
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.
Arm/Group Title Carfilzomib (A0)
Hide Arm/Group Description:

Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle.

Assessed by principal investigator.

Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: participants
Clinical Benefit Response (sCR+CR+VGPR+PR+MR) 10
Complete Response 0
Very Good Partial Response 0
Partial Response 7
Minimal Response 3
3.Secondary Outcome
Title Clinical Benefit Response (CBR) (A1 Only)
Hide Description sCR, CR, VGPR, PR, and minimal response (MR)
Time Frame Response assessments same as described in primary outcome measure
Hide Outcome Measure Data
Hide Analysis Population Description

Response-Evaluable Population:

  1. had measurable disease at Baseline
  2. received at least 1 dose of carfilzomib
  3. underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib
Arm/Group Title Carfilzomib (A1)
Hide Arm/Group Description:

In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.

Assessed by Independent Review Committee

Overall Number of Participants Analyzed 257
Measure Type: Number
Unit of Measure: participants
Clinical Benefit Response (sCR+CR+VGPR+PR+MR) 95
Complete Response 1
Very Good Partial Response 13
Partial Response 47
Minimal Response 34
4.Secondary Outcome
Title Duration of Response (A0 Only)
Hide Description Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.
Time Frame Response assessments same as described in primary outcome measure
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See analysis population description of response-evaluable population above.
Arm/Group Title Carfilzomib (A0) for (ORR)
Hide Arm/Group Description:
Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
Overall Number of Participants Analyzed 7
Median (95% Confidence Interval)
Unit of Measure: days
219 [1] 
(57 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable/available (not estimable [NE]) because an insufficient number of participants reached the event at the final time point for assessment (3 of 7 responders had an event).
5.Secondary Outcome
Title Duration of Response (A1 Only)
Hide Description Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.
Time Frame Response assessments same as described in primary outcome measure
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See overall analysis population description of response-evaluable population above.
Arm/Group Title Carfilzomib (A1) for (ORR) Carfilzomib (A1) for (CBR)
Hide Arm/Group Description:
In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with ORR.
In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with CBR.
Overall Number of Participants Analyzed 61 95
Median (95% Confidence Interval)
Unit of Measure: months
7.8
(5.6 to 9.2)
8.3
(6.5 to 9.7)
6.Secondary Outcome
Title Time to Progression (A0 Only)
Hide Description Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.
Time Frame Response assessments same as described in primary outcome measure
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.
Arm/Group Title Carfilzomib (A0)
Hide Arm/Group Description:

Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle.

Assesed by principal investigator.

Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: months
3.5
(2.4 to 6.7)
7.Secondary Outcome
Title Time to Progression (A1 Only)
Hide Description Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.
Time Frame Response assessments same as described in primary outcome measure
Hide Outcome Measure Data
Hide Analysis Population Description

Response-Evaluable Population:

  1. had measurable disease at Baseline
  2. received at least 1 dose of carfilzomib
  3. underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib
Arm/Group Title Carfilzomib (A1)
Hide Arm/Group Description:

In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.

Assessed by Independent Review Committee

Overall Number of Participants Analyzed 257
Median (95% Confidence Interval)
Unit of Measure: months
3.9
(2.8 to 4.8)
8.Secondary Outcome
Title Progression-free Survival (A0 Only)
Hide Description The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.
Time Frame Response assessments same as described in primary outcome measure
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.
Arm/Group Title Carfilzomib (A0)
Hide Arm/Group Description:
Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: months
3.5
(2.4 to 6.7)
9.Secondary Outcome
Title Progression-free Survival (A1 Only)
Hide Description The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.
Time Frame Response assessments same as described in primary outcome measure
Hide Outcome Measure Data
Hide Analysis Population Description

Response-Evaluable Population:

  1. had measurable disease at Baseline
  2. received at least 1 dose of carfilzomib
  3. underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib
Arm/Group Title Carfilzomib (A1)
Hide Arm/Group Description:
In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
Overall Number of Participants Analyzed 257
Median (95% Confidence Interval)
Unit of Measure: months
3.7
(2.8 to 4.6)
10.Secondary Outcome
Title Overall Survival (A1 Only)
Hide Description The time from start of treatment to death due to any cause OS was to be censored on the date the subject was last known to be alive for those who were alive or lost to follow-up as of a data analysis cutoff date.
Time Frame Patients were to be followed by telephone contact for disease progression and OS every 3 months after study discontinuation for the first year and every 6 months thereafter for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carfilzomib (A1) - Safety Population Carfilzomib (A1) - Response-evaluable Population
Hide Arm/Group Description:

In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.

Safety population: The safety population was used for the analysis of safety data in this study. The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib. However, for some safety analyses, at least 1 laboratory, neurological, electrocardiogram, or vital sign measurement obtained subsequent to at least 1 dose of carfilzomib was required for inclusion in the analysis of a safety specific parameter. To assess change from baseline, a baseline measurement was also required.

In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.

Response-Evaluable Population(the primary analysis population) was defined as all patients who

  • had measurable disease at Baseline by either M-protein (serum and/or urine) or by quantitative serum Ig for certain patients with IgA myeloma
  • received at least 1 dose of carfilzomib
  • underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or patients who discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib—irrespective of availability of baseline and post-baseline assessment
Overall Number of Participants Analyzed 266 257
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: months
15.4
(12.5 to 19.0)
15.6
(13.0 to 19.2)
Time Frame All adverse events (AEs) should be reported from the time the subject signs consent through 30 days post-last dose of study drug or initiation of a new anti-cancer therapy, whichever occurs first.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carfilzomib (A0) Carfilzomib (A1)
Hide Arm/Group Description Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
All-Cause Mortality
Carfilzomib (A0) Carfilzomib (A1)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carfilzomib (A0) Carfilzomib (A1)
Affected / at Risk (%) Affected / at Risk (%)
Total   20/46 (43.48%)   126/266 (47.37%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/46 (0.00%)  5/266 (1.88%) 
Thrombocytopenia * 1  0/46 (0.00%)  5/266 (1.88%) 
Febrile neutropenia * 1  0/46 (0.00%)  2/266 (0.75%) 
Cardiac disorders     
Cardiac failure congestive * 1  2/46 (4.35%)  8/266 (3.01%) 
Cardiac failure * 1  1/46 (2.17%)  0/266 (0.00%) 
Cardiomyopathy * 1  1/46 (2.17%)  0/266 (0.00%) 
Myocardial ischaemia * 1  1/46 (2.17%)  2/266 (0.75%) 
Supraventricular tachycardia * 1  1/46 (2.17%)  0/266 (0.00%) 
Cardiac arrest * 1  0/46 (0.00%)  4/266 (1.50%) 
Atrial fibrillation * 1  0/46 (0.00%)  2/266 (0.75%) 
Acute coronary syndrome * 1  0/46 (0.00%)  1/266 (0.38%) 
Acute myocardial infarction * 1  0/46 (0.00%)  1/266 (0.38%) 
Aortic valve stenosis * 1  0/46 (0.00%)  1/266 (0.38%) 
Arrhythmia * 1  0/46 (0.00%)  1/266 (0.38%) 
Atrial flutter * 1  0/46 (0.00%)  1/266 (0.38%) 
Congestive cardiomyopathy * 1  0/46 (0.00%)  1/266 (0.38%) 
Ventricular dysfunction * 1  0/46 (0.00%)  1/266 (0.38%) 
Endocrine disorders     
Hypercalcaemia of malignancy * 1  0/46 (0.00%)  1/266 (0.38%) 
Eye disorders     
Diplopia * 1  0/46 (0.00%)  1/266 (0.38%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  0/46 (0.00%)  1/266 (0.38%) 
Diarrhoea * 1  0/46 (0.00%)  1/266 (0.38%) 
Dysphagia * 1  0/46 (0.00%)  1/266 (0.38%) 
Intra-abdominal haemorrhage * 1  0/46 (0.00%)  1/266 (0.38%) 
Pancreatitis * 1  0/46 (0.00%)  1/266 (0.38%) 
Vomiting * 1  0/46 (0.00%)  1/266 (0.38%) 
General disorders     
Disease progression * 1  5/46 (10.87%)  16/266 (6.02%) 
Multi-organ failure * 1  1/46 (2.17%)  0/266 (0.00%) 
Non-cardiac chest pain * 1  1/46 (2.17%)  3/266 (1.13%) 
Pyrexia * 1  1/46 (2.17%)  8/266 (3.01%) 
Asthenia * 1  0/46 (0.00%)  1/266 (0.38%) 
Chills * 1  0/46 (0.00%)  1/266 (0.38%) 
Death * 1  0/46 (0.00%)  1/266 (0.38%) 
Infusion related reaction * 1  0/46 (0.00%)  1/266 (0.38%) 
Pain * 1  0/46 (0.00%)  1/266 (0.38%) 
Hepatobiliary disorders     
Hepatic failure * 1  0/46 (0.00%)  2/266 (0.75%) 
Immune system disorders     
Hypersensitivity * 1  0/46 (0.00%)  1/266 (0.38%) 
Infections and infestations     
Pneumonia * 1  5/46 (10.87%)  23/266 (8.65%) 
Bacteraemia * 1  2/46 (4.35%)  1/266 (0.38%) 
Clostridium colitis * 1  1/46 (2.17%)  0/266 (0.00%) 
Klebsiella sepsis * 1  1/46 (2.17%)  0/266 (0.00%) 
Lobar pneumonia * 1  1/46 (2.17%)  2/266 (0.75%) 
Sepsis * 1  1/46 (2.17%)  4/266 (1.50%) 
Cellulitis * 1  0/46 (0.00%)  2/266 (0.75%) 
Upper respiratory tract infection * 1  0/46 (0.00%)  2/266 (0.75%) 
Central line infection * 1  0/46 (0.00%)  1/266 (0.38%) 
Chronic sinusitis * 1  0/46 (0.00%)  1/266 (0.38%) 
Ear infection * 1  0/46 (0.00%)  1/266 (0.38%) 
Escherichia bacteraemia * 1  0/46 (0.00%)  1/266 (0.38%) 
Fusobacterium infection * 1  0/46 (0.00%)  1/266 (0.38%) 
Gastroenteritis viral * 1  0/46 (0.00%)  1/266 (0.38%) 
Infection * 1  0/46 (0.00%)  1/266 (0.38%) 
Otitis media * 1  0/46 (0.00%)  1/266 (0.38%) 
Parainfluenzae virus infection * 1  0/46 (0.00%)  1/266 (0.38%) 
Pneumonia respiratory syncytial viral * 1  0/46 (0.00%)  1/266 (0.38%) 
Respiratory syncytial virus infection * 1  0/46 (0.00%)  1/266 (0.38%) 
Septic shock * 1  0/46 (0.00%)  1/266 (0.38%) 
Injury, poisoning and procedural complications     
Post procedural haemorrhage * 1  1/46 (2.17%)  0/266 (0.00%) 
Subdural haematoma * 1  0/46 (0.00%)  1/266 (0.38%) 
Investigations     
Blood creatinine increased * 1  0/46 (0.00%)  5/266 (1.88%) 
Alanine aminotransferase increased * 1  0/46 (0.00%)  1/266 (0.38%) 
Aspartate aminotransferase increased * 1  0/46 (0.00%)  1/266 (0.38%) 
Hepatic enzyme abnormal * 1  0/46 (0.00%)  1/266 (0.38%) 
Transaminases increased * 1  0/46 (0.00%)  1/266 (0.38%) 
Metabolism and nutrition disorders     
Hypercalcaemia * 1  2/46 (4.35%)  6/266 (2.26%) 
Hyponatraemia * 1  1/46 (2.17%)  1/266 (0.38%) 
Dehydration * 1  0/46 (0.00%)  3/266 (1.13%) 
Fluid overload * 1  0/46 (0.00%)  2/266 (0.75%) 
Hyperkalaemia * 1  0/46 (0.00%)  1/266 (0.38%) 
Musculoskeletal and connective tissue disorders     
Bone pain * 1  1/46 (2.17%)  2/266 (0.75%) 
Pathological fracture * 1  1/46 (2.17%)  8/266 (3.01%) 
Back pain * 1  0/46 (0.00%)  1/266 (0.38%) 
Shoulder pain * 1  0/46 (0.00%)  1/266 (0.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour lysis syndrome * 1  2/46 (4.35%)  0/266 (0.00%) 
Plasmacytoma * 1  1/46 (2.17%)  2/266 (0.75%) 
Nervous system disorders     
Spinal cord compression * 1  0/46 (0.00%)  6/266 (2.26%) 
Syncope * 1  0/46 (0.00%)  2/266 (0.75%) 
Haemorrhage intracranial * 1  0/46 (0.00%)  1/266 (0.38%) 
Hepatic encephalopathy * 1  0/46 (0.00%)  1/266 (0.38%) 
Migraine * 1  0/46 (0.00%)  1/266 (0.38%) 
Neuropathy * 1  0/46 (0.00%)  1/266 (0.38%) 
Syncope vasovagal * 1  0/46 (0.00%)  1/266 (0.38%) 
Transient ischaemic attack * 1  0/46 (0.00%)  1/266 (0.38%) 
Psychiatric disorders     
Mental status changes * 1  0/46 (0.00%)  2/266 (0.75%) 
Confusional state * 1  0/46 (0.00%)  1/266 (0.38%) 
Delirium * 1  0/46 (0.00%)  1/266 (0.38%) 
Renal and urinary disorders     
Renal failure acute * 1  4/46 (8.70%)  9/266 (3.38%) 
Nephrolithiasis * 1  1/46 (2.17%)  0/266 (0.00%) 
Renal failure * 1  1/46 (2.17%)  3/266 (1.13%) 
Haematuria * 1  0/46 (0.00%)  1/266 (0.38%) 
Renal impairment * 1  0/46 (0.00%)  1/266 (0.38%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/46 (2.17%)  5/266 (1.88%) 
Pulmonary oedema * 1  1/46 (2.17%)  2/266 (0.75%) 
Respiratory failure * 1  1/46 (2.17%)  1/266 (0.38%) 
Pleural effusion * 1  0/46 (0.00%)  3/266 (1.13%) 
Hypoxia * 1  0/46 (0.00%)  2/266 (0.75%) 
Pulmonary embolism * 1  0/46 (0.00%)  2/266 (0.75%) 
Acute pulmonary oedema * 1  0/46 (0.00%)  1/266 (0.38%) 
Cough * 1  0/46 (0.00%)  1/266 (0.38%) 
Haemoptysis * 1  0/46 (0.00%)  1/266 (0.38%) 
Pneumonitis * 1  0/46 (0.00%)  1/266 (0.38%) 
Pulmonary alveolar haemorrhage * 1  0/46 (0.00%)  1/266 (0.38%) 
Vascular disorders     
Hypotension * 1  0/46 (0.00%)  4/266 (1.50%) 
Deep vein thrombosis * 1  0/46 (0.00%)  2/266 (0.75%) 
Hypertension * 1  0/46 (0.00%)  1/266 (0.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carfilzomib (A0) Carfilzomib (A1)
Affected / at Risk (%) Affected / at Risk (%)
Total   46/46 (100.00%)   266/266 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  34/46 (73.91%)  122/266 (45.86%) 
Thrombocytopenia * 1  23/46 (50.00%)  103/266 (38.72%) 
Lymphopenia * 1  16/46 (34.78%)  62/266 (23.31%) 
Leukopenia * 1  10/46 (21.74%)  37/266 (13.91%) 
Neutropenia * 1  10/46 (21.74%)  48/266 (18.05%) 
Gastrointestinal disorders     
Nausea * 1  16/46 (34.78%)  119/266 (44.74%) 
Diarrhoea * 1  15/46 (32.61%)  86/266 (32.33%) 
Vomiting * 1  8/46 (17.39%)  59/266 (22.18%) 
Constipation * 1  6/46 (13.04%)  56/266 (21.05%) 
Abdominal pain * 1  5/46 (10.87%)  16/266 (6.02%) 
Dyspepsia * 1  5/46 (10.87%)  26/266 (9.77%) 
Dry mouth * 1  3/46 (6.52%)  4/266 (1.50%) 
General disorders     
Fatigue * 1  32/46 (69.57%)  130/266 (48.87%) 
Pyrexia * 1  15/46 (32.61%)  83/266 (31.20%) 
Asthenia * 1  7/46 (15.22%)  40/266 (15.04%) 
Oedema peripheral * 1  9/46 (19.57%)  62/266 (23.31%) 
Chest discomfort * 1  5/46 (10.87%)  6/266 (2.26%) 
Chills * 1  5/46 (10.87%)  42/266 (15.79%) 
Disease progression * 1  5/46 (10.87%)  17/266 (6.39%) 
Injection site irritation * 1  4/46 (8.70%)  4/266 (1.50%) 
Infusion site pain * 1  2/46 (4.35%)  24/266 (9.02%) 
Pain * 1  2/46 (4.35%)  24/266 (9.02%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  3/46 (6.52%)  3/266 (1.13%) 
Infections and infestations     
Upper respiratory tract infection * 1  17/46 (36.96%)  71/266 (26.69%) 
Pneumonia * 1  5/46 (10.87%)  32/266 (12.03%) 
Nasopharyngitis * 1  3/46 (6.52%)  13/266 (4.89%) 
Urinary tract infection * 1  0/46 (0.00%)  19/266 (7.14%) 
Injury, poisoning and procedural complications     
Contusion * 1  2/46 (4.35%)  14/266 (5.26%) 
Investigations     
Blood creatinine increased * 1  16/46 (34.78%)  67/266 (25.19%) 
Blood bicarbonate decreased * 1  14/46 (30.43%)  6/266 (2.26%) 
Aspartate aminotransfersae increased * 1  9/46 (19.57%)  27/266 (10.15%) 
Blood chloride increased * 1  8/46 (17.39%)  1/266 (0.38%) 
Blood urea increased * 1  7/46 (15.22%)  4/266 (1.50%) 
Blood uric acid increased * 1  7/46 (15.22%)  15/266 (5.64%) 
Blood glucose increased * 1  5/46 (10.87%)  2/266 (0.75%) 
Blood lactate dehydrogenase increased * 1  4/46 (8.70%)  8/266 (3.01%) 
Carbon dioxide decreased * 1  4/46 (8.70%)  2/266 (0.75%) 
Alanine aminotransferase decreased * 1  3/46 (6.52%)  1/266 (0.38%) 
Alanine aminotransferase increased * 1  3/46 (6.52%)  20/266 (7.52%) 
Neutrophil percentage increased * 1  3/46 (6.52%)  0/266 (0.00%) 
White blood cell count decreased * 1  3/46 (6.52%)  5/266 (1.88%) 
Weight decreased * 1  1/46 (2.17%)  20/266 (7.52%) 
Blood albumin decreased * 1  3/46 (6.52%)  4/266 (1.50%) 
Blood calcium increased * 1  3/46 (6.52%)  5/266 (1.88%) 
Blood sodium decreased * 1  3/46 (6.52%)  0/266 (0.00%) 
Blood phosphorus decreased * 1  3/46 (6.52%)  12/266 (4.51%) 
Lymphocyte percentage decreased * 1  3/46 (6.52%)  1/266 (0.38%) 
Metabolism and nutrition disorders     
Hypocalcaemia * 1  16/46 (34.78%)  14/266 (5.26%) 
Hypoalbuminaemia * 1  12/46 (26.09%)  14/266 (5.26%) 
Anorexia * 1  10/46 (21.74%)  35/266 (13.16%) 
Hypercalcaemia * 1  7/46 (15.22%)  36/266 (13.53%) 
Hypokalaemia * 1  7/46 (15.22%)  29/266 (10.90%) 
Hyperphosphataemia * 1  6/46 (13.04%)  7/266 (2.63%) 
Hypophosphataemia * 1  6/46 (13.04%)  32/266 (12.03%) 
Hypermagnesaemia * 1  5/46 (10.87%)  3/266 (1.13%) 
Decreased appetite * 1  4/46 (8.70%)  19/266 (7.14%) 
Hypoglycaemia * 1  3/46 (6.52%)  6/266 (2.26%) 
Hyponatraemia * 1  10/46 (21.74%)  31/266 (11.65%) 
Hyperglycaemia * 1  12/46 (26.09%)  26/266 (9.77%) 
Dehydration * 1  1/46 (2.17%)  18/266 (6.77%) 
Hyperkalaemia * 1  9/46 (19.57%)  14/266 (5.26%) 
Hyperuricaemia * 1  9/46 (19.57%)  11/266 (4.14%) 
Hypomagnesaemia * 1  10/46 (21.74%)  28/266 (10.53%) 
Musculoskeletal and connective tissue disorders     
Chest wall pain * 1  8/46 (17.39%)  32/266 (12.03%) 
Muscle spasms * 1  8/46 (17.39%)  32/266 (12.03%) 
Pain in extremity * 1  8/46 (17.39%)  31/266 (11.65%) 
Arthralgia * 1  6/46 (13.04%)  49/266 (18.42%) 
Back pain * 1  6/46 (13.04%)  63/266 (23.68%) 
Bone pain * 1  5/46 (10.87%)  23/266 (8.65%) 
Shoulder pain * 1  5/46 (10.87%)  28/266 (10.53%) 
Pain in jaw * 1  3/46 (6.52%)  1/266 (0.38%) 
Myalgia * 1  1/46 (2.17%)  22/266 (8.27%) 
Pathological fracture * 1  2/46 (4.35%)  17/266 (6.39%) 
Nervous system disorders     
Headache * 1  12/46 (26.09%)  74/266 (27.82%) 
Hypoaesthesia * 1  5/46 (10.87%)  25/266 (9.40%) 
Areflexia * 1  4/46 (8.70%)  14/266 (5.26%) 
Neuropathic pain * 1  4/46 (8.70%)  9/266 (3.38%) 
Neuropathy peripheral * 1  4/46 (8.70%)  17/266 (6.39%) 
Dizziness * 1  3/46 (6.52%)  30/266 (11.28%) 
Hyporeflexia * 1  3/46 (6.52%)  18/266 (6.77%) 
Neuropathy * 1  3/46 (6.52%)  9/266 (3.38%) 
Paraesthesia * 1  3/46 (6.52%)  20/266 (7.52%) 
Psychiatric disorders     
Insomnia * 1  12/46 (26.09%)  39/266 (14.66%) 
Confusional state * 1  6/46 (13.04%)  17/266 (6.39%) 
Anxiety * 1  2/46 (4.35%)  16/266 (6.02%) 
Depression * 1  2/46 (4.35%)  14/266 (5.26%) 
Renal and urinary disorders     
Renal failure acute * 1  4/46 (8.70%)  13/266 (4.89%) 
Proteinuria * 1  3/46 (6.52%)  0/266 (0.00%) 
Renal failure * 1  3/46 (6.52%)  10/266 (3.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  13/46 (28.26%)  65/266 (24.44%) 
Dyspnoea * 1  13/46 (28.26%)  90/266 (33.83%) 
Crackles lung * 1  4/46 (8.70%)  9/266 (3.38%) 
Dyspnoea exertional * 1  1/46 (2.17%)  33/266 (12.41%) 
Epistaxis * 1  4/46 (8.70%)  29/266 (10.90%) 
Rhinorrhoea * 1  3/46 (6.52%)  21/266 (7.89%) 
Pharyngolaryngeal pain * 1  7/46 (15.22%)  20/266 (7.52%) 
Nasal congestion * 1  2/46 (4.35%)  17/266 (6.39%) 
Productive cough * 1  4/46 (8.70%)  16/266 (6.02%) 
Pleural effusion * 1  1/46 (2.17%)  14/266 (5.26%) 
Bronchospasm * 1  3/46 (6.52%)  0/266 (0.00%) 
Dysphonia * 1  3/46 (6.52%)  3/266 (1.13%) 
Pulmonary oedema * 1  4/46 (8.70%)  5/266 (1.88%) 
Skin and subcutaneous tissue disorders     
Rash * 1  3/46 (6.52%)  20/266 (7.52%) 
Pruritus * 1  1/46 (2.17%)  17/266 (6.39%) 
Vascular disorders     
Hypertension * 1  4/46 (8.70%)  39/266 (14.66%) 
Hypotension * 1  4/46 (8.70%)  21/266 (7.89%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.1)
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.
After the study is completed and all case report forms have been sent to Sponsor, Institution shall have the right to publish or otherwise make public any data resulting from the study under this agreement after publication of a multi-center publication coordinated by Sponsor with respect to the data resulting from the study, or 12 months after the Study is completed at all participating sites if a multi-center publication is not submitted by Sponsor for publication within such 12 month period.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Onyx Medical Information
Organization: Onyx Pharmaceuticals
Phone: 1-877-ONYX-121
EMail: medinfo@onyx.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00511238     History of Changes
Other Study ID Numbers: PX-171-003
First Submitted: August 1, 2007
First Posted: August 3, 2007
Results First Submitted: September 27, 2013
Results First Posted: December 9, 2013
Last Update Posted: August 31, 2017