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The purpose of this study is to assess the influence of renal impairment on carfilzomib in patients with Multiple Myeloma (MM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carfilzomib | Experimental | Carfilzomib, 15 mg/m², was administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib | Drug | Carfilzomib was administered intravenously (IV) at a rate of approximately 10 mL/minute. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clearance (CL) of Carfilzomib on Day 1 of Cycle 1 | Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method. | Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance (CL) of Carfilzomib on Day 15 of Cycle 1 | Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. | |
| Clearance (CL) of Carfilzomib on Day 15 of Cycle 2 | Cycle 2, Day 15, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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Inclusion Criteria:
Written informed consent in accordance with federal, local, and institutional guidelines
Males and females ≥ 18 years of age
Multiple Myeloma
Documented relapsed or progressive disease (PD) after receiving at least two prior treatment regimens (induction therapy with autologous stem cell transplant and maintenance is considered a single regimen), and must have achieved a minimal response or better to at least one of the regimens
Current measurable disease, as indicated by one or more of the following:
Life expectancy of more than three months
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Adequate hepatic function, with bilirubin < 2 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) < 3 times ULN
Total white blood cell (WBC) count ≥ 2,000/mm³
Absolute neutrophil count (ANC) ≥ 1,000/mm³
Hemoglobin ≥ 7 gm/dL
Platelet count ≥ 30,000/ mm³
Female subjects of child-bearing potential must have a negative serum pregnancy test within seven days of the first dose and agree to use dual methods of contraception during and for 3 months following last dose of drug. Post menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from a pregnancy test
Male subjects must use an effective barrier method of contraception during study and for three months following the last dose if sexually active with a female of child-bearing potential
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California- San Francisco | San Francisco | California | 94143 | United States | ||
| University of Maryland Medical Center |
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This study enrolled patients with multiple myeloma (MM) who had relapsed or progressive disease (PD) after at least 1 (original protocol) or 2 (following protocol Amendment 1) prior therapeutic treatments or regimens. Five groups of MM patients, representing different levels of renal function, were evaluated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Carfilzomib - Normal RF | Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1 | Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1 | Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2 | Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1 | Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1 | Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2 | Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1 | Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1 | Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2 | Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
| Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1 | The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose. | Cycle 1, Day 1, 0-5 and 5-24 hours post-dose |
| Percentage of Carfilzomib Excreted Via Renal Elimination on Day 15 of Cycle 1 | The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose. | Cycle 1, Day 15, 0-5 and 5-24 hours post-dose |
| Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1 | The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose. | Cycle 1, Day 1, 0-5 and 5-24 hours post-dose |
| Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1 | The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose. | Cycle 1, Day 15, 0-5 and 5-24 hours post-dose |
| Plasma Protein Binding (PPB) of Carfilzomib | The plasma protein binding (PPB) of carfilzomib in plasma samples was determined using a rapid equilibrium dialysis (RED) device. Data are averages of the 3 time points (Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15). | End of injection and 5 minutes post-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15 |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Uniform Response Criteria for Multiple Myeloma. sCR: CR as defined below plus normal serum free light chain (sFLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or immunofluorescence; CR: absence of M-protein in serum and urine confirmed by immunofixation and < 5% plasma cells in the bone marrow; VGPR: serum and urine M-proteins detectable by immunofixation, but not by electrophoresis or a ≥ 90% reduction in serum M-protein from baseline, plus a urine M-protein level of < 100 mg/24 hours; PR: reduction of M-protein in serum of ≥ 50% and in urine of ≥ 90% from baseline. If serum and urine M-protein were not measureable at baseline, a ≥ 50% decrease in the difference between involved and uninvolved sFLC levels from baseline. | From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days. |
| Clinical Benefit Rate (CBR) | Clinical benefit rate is defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89% from baseline, maintained for at least 6 weeks. | From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days. |
| Duration of Response | Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death. Progressive disease was defined as any of the following:
Median duration of response was estimated using the Kaplan-Meier method. | Participants were followed for disease progression for up to 2 years. |
| Time to Progression (TTP) | Time to Progression is defined as the time from first dose of carfilzomib to disease progression. Median TTP was estimated using Kaplan-Meier methods. | Participants were followed for disease progression for up to 2 years. |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Cornell University | New York | New York | 10021 | United States |
| FG001 | Carfilzomib - Mild RI | Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| FG002 | Carfilzomib - Moderate RI | Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| FG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| FG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Carfilzomib - Normal RF | Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| BG001 | Carfilzomib - Mild RI | Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| BG002 | Carfilzomib - Moderate RI | Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| BG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| BG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active; 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, no self-care, confined to bed or chair; 5 = Dead. | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Clearance (CL) of Carfilzomib on Day 1 of Cycle 1 | Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method. | The pharmacokinetic (PK) evaluable population includes participants with stable baseline renal function (Arms 1-4) who completed all protocol-specified treatment and PK blood sample collection through Cycle 1, Day 16. In Group 5, only samples collected before dialysis were included. CL could not be estimated for 11 patients in the PK population. | Posted | Mean | Standard Deviation | liters/hour | Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Clearance (CL) of Carfilzomib on Day 15 of Cycle 1 | The pharmacokinetic (PK) evaluable population with available data | Posted | Mean | Standard Deviation | liters/hour | Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Clearance (CL) of Carfilzomib on Day 15 of Cycle 2 | The pharmacokinetic (PK) evaluable population with available data | Posted | Mean | Standard Deviation | liters/hour | Cycle 2, Day 15, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1 | PK population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1 | PK population with available data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2 | PK population with available data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1 | PK evaluable population; AUCinf could not be estimated for 11 participants in the PK population who did not have adequate PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1 | PK evaluable population with available data | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2 | PK evaluable population with available data | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1 | PK evaluable population | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1 | PK evaluable population with available data | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2 | PK evaluable population with available data | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose. |
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| Secondary | Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1 | The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose. | Participants in Groups 1-4 with available data | Posted | Mean | Standard Deviation | percentage of carfilzomib dose | Cycle 1, Day 1, 0-5 and 5-24 hours post-dose |
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| Secondary | Percentage of Carfilzomib Excreted Via Renal Elimination on Day 15 of Cycle 1 | The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose. | Participants in Groups 1-4 with available data | Posted | Mean | Standard Deviation | percentage of carfilzomib dose | Cycle 1, Day 15, 0-5 and 5-24 hours post-dose |
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| Secondary | Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1 | The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose. | Participants in Groups 1-4 with available data | Posted | Mean | Standard Deviation | percentage of carfilzomib dose | Cycle 1, Day 1, 0-5 and 5-24 hours post-dose |
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| Secondary | Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1 | The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose. | Participants in Groups 1-4 with available data | Posted | Mean | Standard Deviation | percentage of carfilzomib dose | Cycle 1, Day 15, 0-5 and 5-24 hours post-dose |
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| Secondary | Plasma Protein Binding (PPB) of Carfilzomib | The plasma protein binding (PPB) of carfilzomib in plasma samples was determined using a rapid equilibrium dialysis (RED) device. Data are averages of the 3 time points (Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15). | Participants with available data | Posted | Mean | Standard Deviation | percentage of carfilzomib bound | End of injection and 5 minutes post-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15 |
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| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Uniform Response Criteria for Multiple Myeloma. sCR: CR as defined below plus normal serum free light chain (sFLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or immunofluorescence; CR: absence of M-protein in serum and urine confirmed by immunofixation and < 5% plasma cells in the bone marrow; VGPR: serum and urine M-proteins detectable by immunofixation, but not by electrophoresis or a ≥ 90% reduction in serum M-protein from baseline, plus a urine M-protein level of < 100 mg/24 hours; PR: reduction of M-protein in serum of ≥ 50% and in urine of ≥ 90% from baseline. If serum and urine M-protein were not measureable at baseline, a ≥ 50% decrease in the difference between involved and uninvolved sFLC levels from baseline. | The response evaluable population included all participants with measurable disease and a baseline and at least 1 post-baseline disease assessment or who discontinued study treatment due to a related adverse event prior to obtaining an on-study disease assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days. |
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| Secondary | Clinical Benefit Rate (CBR) | Clinical benefit rate is defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89% from baseline, maintained for at least 6 weeks. | The response evaluable population | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days. |
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| Secondary | Duration of Response | Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death. Progressive disease was defined as any of the following:
Median duration of response was estimated using the Kaplan-Meier method. | Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR. | Posted | Median | 95% Confidence Interval | months | Participants were followed for disease progression for up to 2 years. |
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| Secondary | Time to Progression (TTP) | Time to Progression is defined as the time from first dose of carfilzomib to disease progression. Median TTP was estimated using Kaplan-Meier methods. | Response Evaluable Population | Posted | Median | 95% Confidence Interval | months | Participants were followed for disease progression for up to 2 years. |
|
From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carfilzomib - Normal RF | Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. | 5 | 12 | 12 | 12 | ||
| EG001 | Carfilzomib - Mild RI | Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. | 8 | 12 | 12 | 12 | ||
| EG002 | Carfilzomib - Moderate RI | Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. | 10 | 10 | 10 | 10 | ||
| EG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. | 6 | 8 | 8 | 8 | ||
| EG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. | 8 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Amyloidosis | Immune system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Superior vena caval occlusion | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypocoagulable state | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dilatation atrial | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bowel sounds abnormal | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Colonic haemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Catheter site inflammation | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Mass | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pitting oedema | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Tenderness | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Post procedural vomiting | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal bruit | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood pressure diastolic decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Carbon dioxide decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory rate decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nodule on extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Areflexia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diplegia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyporeflexia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neuropathic pain | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Urine flow decreased | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Superior vena caval occlusion | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen, Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D051437 | Renal Insufficiency |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C524865 | carfilzomib |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian/Pacific Islander |
|
| Caucasian |
|
| 1 (Restrictive but ambulatory) |
|
| 2 (Ambulatory but unable to work) |
|
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
| OG002 |
| Carfilzomib - Moderate RI |
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
| Carfilzomib - Moderate RI |
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
| Carfilzomib - Moderate RI |
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
| Carfilzomib - Moderate RI |
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
| Carfilzomib - Moderate RI |
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
| OG002 | Carfilzomib - Moderate RI | Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
|
|
| OG002 | Carfilzomib - Moderate RI | Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
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| OG002 | Carfilzomib - Moderate RI | Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
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| OG001 | Carfilzomib - Mild RI | Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG002 | Carfilzomib - Moderate RI | Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
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| OG002 | Carfilzomib - Moderate RI | Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
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Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG002 | Carfilzomib - Moderate RI | Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
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| Carfilzomib - Moderate RI |
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG003 | Carfilzomib - Severe RI | Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
| OG004 | Carfilzomib - Dialysis | Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles. |
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