Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase I/II Trial of Carfilzomib, Pegylated Liposomal Doxorubicin, and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma
Acronym
Not provided
Organization
Washington University School of MedicineOTHER
Status Module
Record Verification Date
Apr 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 14, 2012Actual
Primary Completion Date
Dec 28, 2017Actual
Completion Date
Mar 23, 2018Actual
First Submitted Date
Nov 15, 2010
First Submission Date that Met QC Criteria
Nov 22, 2010
First Posted Date
Nov 23, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 17, 2018
Results First Submitted that Met QC Criteria
Apr 4, 2019
Results First Posted Date
Apr 8, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 4, 2019
Last Update Posted Date
Apr 8, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Washington University School of MedicineOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The aim of this phase I/II trial is to determine the maximal tolerated dose (MTD) of carfilzomib together with pegylated liposomal doxorubicin hydrochloride (PLD) with or without dexamethasone, and then to establish the efficacy and safety of this novel combination in patients with relapsed or refractory multiple myeloma
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Myeloma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
40Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Experimental
Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Drug: carfilzomib
Drug: pegylated liposomal doxorubicin (PLD)
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Experimental
Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 1: Carfilzomib IV (1 dose level above MTD) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (1 dose level above MTD) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (1 dose level above MTD) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Dose Level 2: Carfilzomib IV (2 dose levels above MTD) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (2 dose levels above MTD) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (2 dose levels above MTD) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Drug: carfilzomib
Drug: pegylated liposomal doxorubicin (PLD)
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Experimental
Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Drug: carfilzomib
Drug: pegylated liposomal doxorubicin (PLD)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
carfilzomib
Drug
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD) of Carfilzomib and Pegylated Liposomal Doxorubicin (Phase I - Part 1).
MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.
Please note that the maximum tolerated dose of carfilzomib and pegylated liposomal doxorubicin was not reached. The data below is the recommended dosage for further studies.
28 days (completion of first cycle of all Phase I - Part 1 patients)
Maximum Tolerated Dose (MTD) of Carfilzomib and PLD (Phase I - Part 2).
-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.
28 days (completion of first cycle of all Phase I - Part 2 patients)
Maximum Tolerated Dose (MTD) of Dexamethasone (Phase I - Part 2).
-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.
28 days (completion of first cycle of all Phase I - Part 2 patients)
Phase 2 - Efficacy of Carfilzomib in Combination With PLD and Dexamethasone as Measured by the Percentage of Participants With Confirmed Tumor Responses
-A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria.
Completion of treatment (median number of cycles was 9.5 (range 1-34))
Phase 2 - Toxicity of Carfilzomib in Combination With PLD and Dexamethasone as Measured by Number of Participants Who Experience Grade 3/4 Toxicity
Through 30 days after completion of treatment (median number of cycles was 9.5 (range 1-34))
Secondary Outcomes
Measure
Description
Time Frame
Median Overall Survival
Completion of follow-up (median of 23.3 months)
Progression-free Survival Time (Phase 2 Only)
-Progression per IMWG Criteria
Through completion of follow-up (median follow-up was 23.3 months)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of multiple myeloma with a measurable disease parameter at time of screening; a measurable disease parameter is defined as one or more of the following:
Serum monoclonal protein >= 0.5 g/dl
24 hour urine monoclonal protein >= 0.2 g/24 hour
Serum free light chain ratio > 5 x normal ratio with an absolute difference of 10mg/dl between the involved and uninvolved free light chain
Soft tissue plasmacytoma >= 2 cm measurable by either physical examination and/or applicable radiographs (e.g. magnetic resonance imaging [MRI], computed tomography [CT], etc)
Bone Marrow Plasma Cells >= 30%
Documentation of at least one line of prior myeloma therapy now with relapsed or refractory disease requiring re-treatment
At least 18 years of age at the time of signing the informed consent.
Performance status of Eastern Cooperative Oncology Group (ECOG) =< 2 or Karnofsky >= 60%; participants with lower performance status based solely on bone pain secondary to multiple myeloma will be eligible
Required laboratory values
Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2.5 x the upper limit of the institutional normal value (ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Absolute neutrophil count (ANC) >= 1,000
Hemoglobin >= 8 g/dl
Platelets >= 50,000
Creatinine clearance > 15 ml/minute using Cockcroft-Gault formula
For those participants receiving warfarin (Coumadin), unfractionated heparin, or low-molecular weight heparin therapy, the applicable coagulation parameter that is being monitored must be within the accepted therapeutic ranges for those indications
Transfusions and/or growth factor dependent participants are not excluded if the above parameters can be achieved with such support
Females of childbearing potential (FCBP) must agree to refrain from becoming pregnant while on study drug and for 3 months after discontinuation from study drug, and must agree to use adequate contraception including hormonal contraception, (i.e. birth control pills, etc), barrier method contraception (i.e. condoms), or abstinence during that time frame; FCBP must agree to regular pregnancy testing during this timeframe; inclusion of FCBP requires two negative pregnancy tests prior to enrollment. All women, regardless of age, should be considered FCBP unless they are surgically sterile (post hysterectomy, post bilateral oophorectomy, etc) or have been naturally post menopausal for >= 24 consecutive months
Men engaging in sexual intercourse with a FCBP must agree to use adequate contraception including hormonal contraception, (i.e. birth control pills, etc), barrier method contraception (i.e. condoms), or abstinence while on study drug and for 3 months after discontinuation from study drug
Ability to understand and willing to sign a written informed consent document
Exclusion Criteria:
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Plasma Cell Leukemia
Waldenstrom's macroglobulinemia
Pregnant or lactating females
Use of any anti-myeloma drug therapy within 14 days of initiation of study drug treatment excluding corticosteroids if given for an indication other than myeloma; bisphosphonates are not considered anti-myeloma drugs
Participation in an investigational therapeutic study within 14 days of initiation of study drug treatment
Radiotherapy to multiple sites or immunotherapy within 14 days of initiation of study drug treatment (localized radiotherapy to a single site at least 7 days before start is permissible)
Major surgery within 14 days of initiation of study drug treatment
Participants in whom the required program of oral (PO) and IV fluid hydration is contraindicated
Prior history of a hypersensitivity reaction to PLD, doxorubicin, bortezomib, carfilzomib, or liposomal drug formulations other than PLD; history of reactions to liposomal drug formulations other than PLD should be evaluated individually and if their reactions were felt to have been due to the encapsulated agent, rather than the liposomal component itself they should be excluded at the discretion of the investigators
Participants who are known to have active hepatitis A, B, or C viral infection may not participate in this study; active disease is defined as participants with a known viral hepatitis whose liver function tests are elevated
Known human immunodeficiency virus (HIV)-seropositive and are taking anti-retrovirals may not participate in this study; participants who are HIV-seropositive and not on anti-retroviral therapy and who otherwise meet the inclusion/exclusion criteria will be eligible for the study
Compromised cardiovascular function defined as any of the following:
Electrocardiogram (EKG) evidence of acute ischemia
EKG evidence of medically significant conduction system abnormalities
History of myocardial infarction within the last 6 months
Unstable angina pectoris or cardiac arrhythmia
History of Class 3 or Class 4 New York Heart Association Congestive Heart Failure within 6 months of enrollment on study
Left ventricular ejection fraction (LVEF) < 45% by either echocardiography or radionuclide-based multiple gated acquisition (Echo or MUGA)
Uncontrolled concurrent illness including: other hematologic or non-hematologic malignancy, active infection, or uncontrolled diabetes
Any significant psychological, medical, or surgical condition thought to compromise the participant, the study, or prevent informed consent
Schroeder MA, Fiala MA, Huselton E, Cardone MH, Jaeger S, Jean SR, Shea K, Ghobadi A, Wildes T, Stockerl-Goldstein KE, Vij R. A Phase I/II Trial of Carfilzomib, Pegylated Liposomal Doxorubicin, and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2019 Jul 1;25(13):3776-3783. doi: 10.1158/1078-0432.CCR-18-1909. Epub 2019 Apr 5.
See Also Links
Label
URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
The study opened to participant enrollment on 05/14/2012 and closed to participant enrollment on 08/02/2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP_ICF
Yes
Yes
Yes
Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Dec 4, 2015
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Experimental
Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Drug: carfilzomib
Drug: pegylated liposomal doxorubicin (PLD)
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Experimental
Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Drug: carfilzomib
Drug: pegylated liposomal doxorubicin (PLD)
Drug: Dexamethasone
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Experimental
Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Drug: carfilzomib
Drug: pegylated liposomal doxorubicin (PLD)
Drug: Dexamethasone
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Kyprolis
CFZ
pegylated liposomal doxorubicin (PLD)
Drug
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
DOXIL
Dexamethasone
Drug
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Decadron
Median Duration of Overall Response
For participants with confirmed tumor responses
A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria
Through completion of follow-up (median follow-up was 23.3 months)
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
FG002
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
FG003
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
FG004
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
FG005
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
FG0003 subjects
FG0014 subjects
FG0024 subjects
FG0035 subjects
FG0047 subjects
FG00517 subjects
COMPLETED
FG0003 subjects
FG0014 subjects
FG0024 subjects
FG0035 subjects
FG0047 subjects
FG00517 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Dose Level 0: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
BG001
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Dose Level 1: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
BG002
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Dose Level 2: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
BG003
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
BG005
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0014
BG0024
BG0035
BG0047
BG00517
BG00640
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00065(62 to 66)
BG00166.5(53 to 71)
BG00272(55 to 79)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Tolerated Dose (MTD) of Carfilzomib and Pegylated Liposomal Doxorubicin (Phase I - Part 1).
MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.
Please note that the maximum tolerated dose of carfilzomib and pegylated liposomal doxorubicin was not reached. The data below is the recommended dosage for further studies.
Participants enrolled in the Phase I - Part 1 portion of this study were the only evaluable participants for this outcome measure.
Posted
Number
mg/m^2
28 days (completion of first cycle of all Phase I - Part 1 patients)
ID
Title
Description
OG000
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
OG001
Phase I - Part 2
Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
OG002
Phase 2
Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Units
Counts
Participants
OG00016
OG0010
OG0020
Title
Denominators
Categories
Carfilzomib Recommended Dose
Title
Measurements
OG00056
Pegylated liposomal doxorubicin recommended dose
Title
Measurements
OG00030
Primary
Maximum Tolerated Dose (MTD) of Carfilzomib and PLD (Phase I - Part 2).
-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.
Participants enrolled in the Phase I - Part 2 portion of this study were the only evaluable participants for this outcome measure.
Posted
Number
mg/m^2
28 days (completion of first cycle of all Phase I - Part 2 patients)
ID
Title
Description
OG000
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
OG001
Phase I - Part 2
Primary
Maximum Tolerated Dose (MTD) of Dexamethasone (Phase I - Part 2).
-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.
Participants enrolled in the Phase I - Part 2 portion of this study were the only evaluable participants for this outcome measure.
Posted
Number
mg
28 days (completion of first cycle of all Phase I - Part 2 patients)
ID
Title
Description
OG000
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
OG001
Phase I - Part 2
Primary
Phase 2 - Efficacy of Carfilzomib in Combination With PLD and Dexamethasone as Measured by the Percentage of Participants With Confirmed Tumor Responses
-A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria.
For this outcome measure the Phase I - Part 1 Dose Level 3 and Phase I - Part 2 participants were combined with the Phase 2 participants as they received the same dosing of carfilzomib. The remaining Phase I - Part 1 participants were not evaluable for this outcome measure.
Posted
Count of Participants
Participants
Completion of treatment (median number of cycles was 9.5 (range 1-34))
ID
Title
Description
OG000
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Primary
Phase 2 - Toxicity of Carfilzomib in Combination With PLD and Dexamethasone as Measured by Number of Participants Who Experience Grade 3/4 Toxicity
For this outcome measure the Phase I - Part 2 participants were combined with the Phase 2 participants as they received the same dosing regimen. Phase I - Part 1 participants were not evaluable for this outcome measure.
Posted
Count of Participants
Participants
Through 30 days after completion of treatment (median number of cycles was 9.5 (range 1-34))
ID
Title
Description
OG000
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
OG001
Phase 2 (Includes Phase I - Part 2 Participants)
Secondary
Median Overall Survival
Posted
Median
95% Confidence Interval
months
Completion of follow-up (median of 23.3 months)
ID
Title
Description
OG000
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Dose Level 0: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
OG001
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Dose Level 1: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
OG002
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Dose Level 2: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
OG003
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Secondary
Progression-free Survival Time (Phase 2 Only)
-Progression per IMWG Criteria
This outcome measure is for Phase 2 (including Phase I Part 2) participants only. Phase I Part 2 and Phase 2 participants who began alternative anti-multiple myeloma treatment prior to progression were censored.
Posted
Median
95% Confidence Interval
months
Through completion of follow-up (median follow-up was 23.3 months)
ID
Title
Description
OG000
Phase I - Part 1
Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
OG001
Phase 2 (Includes Phase I - Part 2 Participants)
Secondary
Median Duration of Overall Response
For participants with confirmed tumor responses
A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria
Posted
Median
95% Confidence Interval
months
Through completion of follow-up (median follow-up was 23.3 months)
ID
Title
Description
OG000
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Dose Level 0: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
OG001
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Dose Level 1: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
OG002
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Dose Level 2: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Time Frame
Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
Dose Level 0: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (27 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
0
3
2
3
3
3
EG001
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
Dose Level 1: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (36 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
0
4
3
4
4
4
EG002
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
Dose Level 2: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (45 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
2
4
4
4
4
4
EG003
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m^2) D1&D2 of C1 and carfilzomib IV (56 mg/m^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m^2)D8 C1-6.
0
5
3
5
5
5
EG004
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
0
7
2
7
7
7
EG005
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
1
17
10
17
17
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG0030 affected5 at risk
EG004
Aortic valve disease
Cardiac disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Diverticulitis
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Fever
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Infusion related reaction
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Weakness
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Acute bronchitis
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
RSV infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0023 affected4 at risk
EG003
Skin infection (cellulitis)
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Skin infection (MRSA)
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Skin infection (shingles)
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Upper respiratory infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Polypharmacy
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Left hip pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Plasmacytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Acute encephalopathy
Nervous system disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Acute rental failure
Renal and urinary disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
COPD exacerbation
Respiratory, thoracic and mediastinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Dyspnea (COPD exacerbation)
Respiratory, thoracic and mediastinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Thromboembolic event (DVT)
Vascular disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected4 at risk
EG0024 affected4 at risk
EG0034 affected5 at risk
EG0046 affected7 at risk
EG00514 affected17 at risk
Hemolysis
Blood and lymphatic system disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lymph node swelling
Blood and lymphatic system disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Heart failure
Cardiac disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Heart murmur
Cardiac disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Myocardial infarction
Cardiac disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Sinus bradycardia
Cardiac disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Tricuspid valve disease
Cardiac disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Ear pain
Ear and labyrinth disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Right ear fullness
Ear and labyrinth disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Tinnitus
Ear and labyrinth disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Vertigo
Ear and labyrinth disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Blurred vision
Eye disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Cataract
Eye disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Conjunctivitis
Eye disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Dry eye
Eye disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Eye erythema
Eye disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Flashing lights
Eye disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Subconjunctival hemorrhage
Eye disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Watering eyes
Eye disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0022 affected4 at risk
EG003
Anal fistula
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Anal pain
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Bloating
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0003 affected3 at risk
EG0013 affected4 at risk
EG0023 affected4 at risk
EG003
Dental caries
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0023 affected4 at risk
EG003
Diverticulitis
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Fecal incontinence
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Gastroenteritis
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Hemorrhoids
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypersalivating
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Ileus
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Indigestion
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Mouth sores
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Mucositits oral
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0003 affected3 at risk
EG0011 affected4 at risk
EG0023 affected4 at risk
EG003
Oral dysesthesia
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Oral pain
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Rectal pain
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Rectal ulcer
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Sores at corner of mouth
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Stomach flu
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Stomach pain
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Stomach virus
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Upset stomach
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCAE (4.0)
Systematic Assessment
EG0003 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Achy
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Black spot-tongue
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Chills
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Edema face
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Edema limbs
General disorders
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0021 affected4 at risk
EG003
Fatigue
General disorders
CTCAE (4.0)
Systematic Assessment
EG0003 affected3 at risk
EG0012 affected4 at risk
EG0023 affected4 at risk
EG003
Fever
General disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0023 affected4 at risk
EG003
Flu Like Symptoms
General disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Generalized pain
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Groin pain
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hand pain
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
IV site swelling
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Infusion related reaction
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Infusion site extravasation
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Injection like reaction
General disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Kidney pain cramping
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Legs/jaw/head pain
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Localized edema
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Localized edema-feet
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Malaise
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Neck edema
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Night sweats
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Pain
General disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rib cage pain
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Shoulder blade pain
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Sweating
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Gallstones
Hepatobiliary disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Anorectal infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Bone infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
C. diff colitis
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Conjunctivitis infective
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Finger wart
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Groin infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lip infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lung infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Nail infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Oral candidiasis/thrush
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Otitis media
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pain-head to toe
General disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Perianal abscess
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Salivary gland infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Sinusitis
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Skin infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Stool (+) VRE
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Stool (+) norovirus
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Stye
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Tooth infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Upper respiratory infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Viral illness
Infections and infestations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Bruising
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Elbow wound
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0023 affected4 at risk
EG003
Fracture
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Great toe wound
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Phalangeal fracture
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rib fractures
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Right foot fracture
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Spinal fracture - pathologic
Injury, poisoning and procedural complications
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0023 affected4 at risk
EG003
Alkaline phosphatase increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0023 affected4 at risk
EG003
Blood bilirubin increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
CPK increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Cardiac troponin I increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Cholesterol high
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Creatinine increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0003 affected3 at risk
EG0012 affected4 at risk
EG0023 affected4 at risk
EG003
INR increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lipase increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0003 affected3 at risk
EG0011 affected4 at risk
EG0023 affected4 at risk
EG003
Lymphocyte count increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Neutrophil count decreased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected4 at risk
EG0021 affected4 at risk
EG003
Platelet count decreased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0023 affected4 at risk
EG003
Serum amylase increased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Weight gain
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Weight loss
Investigations
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
White blood cell decreased
Investigations
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected4 at risk
EG0023 affected4 at risk
EG003
Anorexia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0022 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Diabetes type 2
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0021 affected4 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected4 at risk
EG0020 affected4 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected4 at risk
EG0021 affected4 at risk
EG003
Hyperphosphatemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Hypertriglyceridemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hyperuricemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0022 affected4 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0023 affected4 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0003 affected3 at risk
EG0013 affected4 at risk
EG0024 affected4 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0022 affected4 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0022 affected4 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0023 affected4 at risk
EG003
Iron overload
Metabolism and nutrition disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Achiness hips
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0022 affected4 at risk
EG003
Body aches
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Buttock pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Cramping arms, hands, and feet
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Cramping hands and feet
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Elbow pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Foot pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Hip pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hip/leg pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Intercostal pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Joint range of motion decreased in lumbar spine
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Leg cramps
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Muscle cramps/spasms
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Muscle spasms-hands
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Muscle weakness-hands
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Muscle weakness/heaviness lower limbs
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Osteonecrosis of palate
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rib pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Right armpit pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Right rib cage pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Right side pain with deep breath
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Rotator cuff tear full/partial
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Shoulder pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Shoulder spasm
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Warm spot on thigh
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Wrist pain
Musculoskeletal and connective tissue disorders
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
BCCA Nasal Ala
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Enlarging pulmonary nodule
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
T10 lesion-invasion into spinal cord
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (4.0)
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
OG002
Phase 2
Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Units
Counts
Participants
OG0000
OG0017
OG0020
Title
Denominators
Categories
Carfilzomib dose
Title
Measurements
OG00156
Pegylated liposomal doxorubicin dose
Title
Measurements
OG00130
Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
OG002
Phase 2
Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Units
Counts
Participants
OG0000
OG0017
OG0020
Title
Denominators
Categories
Title
Measurements
OG00120
OG001
Phase 2 (Includes Phase I - Part 2 Participants)
Phase I Part 2 Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Units
Counts
Participants
OG0000
OG00124
Title
Denominators
Categories
Title
Measurements
OG00120
Phase I Part 2 Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Units
Counts
Participants
OG0000
OG00124
Title
Denominators
Categories
Title
Measurements
OG00122
Dose Level 3: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
OG005
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Units
Counts
Participants
OG0003
OG0014
OG0024
OG0035
OG0047
OG00517
Title
Denominators
Categories
Title
Measurements
OG00025.490(.000 to 60.025)
OG00118.780(1.493 to 36.067)
OG00211.610(.000 to 23.889)
OG00332.340(.000 to 86.811)
OG00418.720(8.660 to 28.780)
OG005NA(NA to NA)The median overall survival was not reached in the follow-up time period.
Phase I Part 2 Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Phase 2: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Units
Counts
Participants
OG0000
OG0018
Title
Denominators
Categories
Title
Measurements
OG00113.4(5.0 to 21.7)
OG003
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
Dose Level 3: Carfilzomib IV (20 mg/m2) D1&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
Cohort 0: Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
OG005
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
Carfilzomib IV (56 mg/^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
Units
Counts
Participants
OG0001
OG0012
OG0022
OG0034
OG0045
OG00515
Title
Denominators
Categories
Title
Measurements
OG0006.090(NA to NA)The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates.
OG0016.840(NA to NA)The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates.
OG0023.420(NA to NA)The 95% confidence interval was not estimable as no one was censored so the numbers are actuals and not estimates.