Extensive-Stage Small-Cell Lung Cancer
Conditions
Brief summary
The purpose of this study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib given in combination with carboplatin and etoposide as initial therapy for patients with extensive-stage small-cell lung cancer (ES SCLC).
Interventions
DRUGCarfilzomib
Administered by intravenous infusion.
DRUGCarboplatin
Administered by intravenous infusion.
DRUGEtoposide
Administered by intravenous infusion.
Sponsors
Amgen
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of extensive-stage small-cell lung cancer (ES-SCLC) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; ES-SCLC is defined as: small-cell lung cancer (SCLC) that has spread beyond one hemithorax and regional lymph nodes on the same side (e.g., supraclavicular) to the contralateral hemithorax, lymph nodes, or more distant locations in the body 2. Subjects with asymptomatic brain metastases or other central nervous system (CNS) disease at screening/diagnosis are eligible 3. Males and females ≥ 18 years of age 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Key
Exclusion criteria
1. Previous systemic therapy to treat small-cell lung cancer (SCLC). Subjects with recurrent or progressive limited-stage SCLC after previous systemic treatment are not eligible for study participation. 2. Whole brain or focal radiation therapy within 14 days prior to Cycle 1 Day 1 (C1D1) for Phase 1b or prior to randomization for Phase 2 3. Congestive heart failure (New York Heart Association \[NYHA\] class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to prior to C1D1 for Phase 1b or prior to randomization for Phase 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities | First 21-day Cycle | The maximum tolerated dose (MTD) was defined as the highest dose level at which \< 33% of participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle. Dose-limiting toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. A DLT was defined as: * A grade 3 or greater non-hematologic toxicity that was assessed as related to carfilzomib by the investigator except in the case of neuropathy. A grade 2 or higher neuropathy with pain was considered a DLT. * Grade 4 neutropenia: absolute neutrophil count (ANC) \< 500 mm³, lasting ≥ 7 days despite granulocyte colony stimulating factor support, or any febrile (temperature \> 38.3°C) neutropenia (ANC \< 1000 mm³). * Thrombocytopenia of any grade associated with clinically significant bleeding or platelet/blood transfusion * Grade 4 fatigue lasting ≥ 7 days * Grade 3 nausea, vomiting or diarrhea lasting ≥ 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) - Phase 2 | 30 months | Overall Survival (OS) is defined as the time from randomization to the date of death. Overall survival was a specified secondary endpoint for the phase 2 portion of the study; since phase 2was not conducted, OS was not analyzed. |
| Maximum Plasma Concentration - Phase 2 | Cycle 1 Day 2 | Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed. |
| Time of Maximum Plasma Concentration - Phase 2 | Cycle 1 Day 2 | Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed. |
| Area Under Plasma Concentration-Time Curve - Phase 2 | Cycle 1 Day 2 | Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed. |
| Number of Participants With Adverse Events (AEs) | From first day of any study treatment (i.e., carfilzomib, carboplatin, or etoposide) up to 30 days after the last day of study treatment. The median overall duration of treatment was 16 weeks. | The severity of each adverse event was assessed using the NCI-CTCAE Version 4.03 according to the following: Grade 1 - Mild: Asymptomatic or mild symptoms; intervention not indicated Grade 2 - Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3 - Severe: Medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL Grade 4 - Life-threatening Grade 5 - Fatal. A serious AE is an AE that met one or more of the following criteria: * Death * Life-threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly/birth defect * Important medical events that required medical or surgical intervention to prevent one of the outcomes above. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks. | Duration of response (DOR) was calculated for participants who achieved a confirmed CR or PR. defined as the time from first evidence of confirmed PR/CR to disease progression or death due to any cause. Median DOR was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored. DOR was originally specified as a secondary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed, DOR was analyzed in phase 1b participants on an exploratory basis. |
| Overall Response Rate | From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks. | The overall response rate (ORR) was defined as the percentage of participants for whom the best overall confirmed response was either complete response (CR) or partial response (PR) assessed by the investigator according to RECIST v1.1 criteria. CR: Disappearance of all target and non-target lesions, no new lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits. |
| Progression-free Survival | From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks. | Progression-free survival (PFS) was specified as a primary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed PFS was analyzed in phase 1b participants on an exploratory basis. PFS was defined as the time from the start of treatment to documented disease progression or death due to any cause, whichever occurred first. Disease progression was determined by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, defined as at least a 20% increase in the size of target lesions (absolute increase ≥ 5 mm), unequivocal progression of existing non-target lesions, or any new lesions. Median PFS was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored. |
Countries
Canada, Russia, United States
Participant flow
Recruitment details
This study was conducted at 17 centers in the United States, Russia, and Canada.
Pre-assignment details
In the phase 1b portion of the study participants were assigned sequentially to escalating doses of carfilzomib given in combination with standard dose carboplatin and etoposide to establish the maximum tolerated dose (MTD). The phase 2 portion of the study was not enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Carfilzomib 20/20 mg/m² Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | 5 |
| Carfilzomib 20/27 mg/m² Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | 3 |
| Carfilzomib 20/36 mg/m² Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | 3 |
| Carfilzomib 20/45 mg/m² Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | 15 |
| Carfilzomib 20/56 mg/m² Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | 6 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Ongoing in Study | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Carfilzomib 20/20 mg/m² | Carfilzomib 20/27 mg/m² | Carfilzomib 20/36 mg/m² | Carfilzomib 20/45 mg/m² | Carfilzomib 20/56 mg/m² | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 13.8 | 62.3 years STANDARD_DEVIATION 8.5 | 59.0 years STANDARD_DEVIATION 7.5 | 56.9 years STANDARD_DEVIATION 9.4 | 58.8 years STANDARD_DEVIATION 7.9 | 59.9 years STANDARD_DEVIATION 10.1 |
| Age, Customized < 65 years | 2 Participants | 2 Participants | 2 Participants | 14 Participants | 5 Participants | 25 Participants |
| Age, Customized ≥ 65 years | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 7 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (Fully active) | 4 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 10 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (Restrictive but ambulatory) | 1 Participants | 3 Participants | 2 Participants | 12 Participants | 4 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 3 Participants | 3 Participants | 14 Participants | 5 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 3 Participants | 3 Participants | 14 Participants | 6 Participants | 31 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 1 Participants | 5 Participants | 1 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 2 Participants | 10 Participants | 5 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 5 | 3 / 3 | 3 / 3 | 15 / 15 | 5 / 6 |
| serious Total, serious adverse events | 1 / 5 | 1 / 3 | 1 / 3 | 7 / 15 | 2 / 6 |
Outcome results
Primary
Number of Participants With Dose-limiting Toxicities
The maximum tolerated dose (MTD) was defined as the highest dose level at which \< 33% of participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle. Dose-limiting toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. A DLT was defined as: * A grade 3 or greater non-hematologic toxicity that was assessed as related to carfilzomib by the investigator except in the case of neuropathy. A grade 2 or higher neuropathy with pain was considered a DLT. * Grade 4 neutropenia: absolute neutrophil count (ANC) \< 500 mm³, lasting ≥ 7 days despite granulocyte colony stimulating factor support, or any febrile (temperature \> 38.3°C) neutropenia (ANC \< 1000 mm³). * Thrombocytopenia of any grade associated with clinically significant bleeding or platelet/blood transfusion * Grade 4 fatigue lasting ≥ 7 days * Grade 3 nausea, vomiting or diarrhea lasting ≥ 7 days.
Time frame: First 21-day Cycle
Population: All participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carfilzomib 20/20 mg/m² | Number of Participants With Dose-limiting Toxicities | 0 Participants |
| Carfilzomib 20/27 mg/m² | Number of Participants With Dose-limiting Toxicities | 0 Participants |
| Carfilzomib 20/36 mg/m² | Number of Participants With Dose-limiting Toxicities | 0 Participants |
| Carfilzomib 20/45 mg/m² | Number of Participants With Dose-limiting Toxicities | 0 Participants |
| Carfilzomib 20/56 mg/m² | Number of Participants With Dose-limiting Toxicities | 1 Participants |
Secondary
Area Under Plasma Concentration-Time Curve - Phase 2
Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.
Time frame: Cycle 1 Day 2
Population: Phase 2 participants
Secondary
Maximum Plasma Concentration - Phase 2
Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.
Time frame: Cycle 1 Day 2
Population: Phase 2 participants
Secondary
Number of Participants With Adverse Events (AEs)
The severity of each adverse event was assessed using the NCI-CTCAE Version 4.03 according to the following: Grade 1 - Mild: Asymptomatic or mild symptoms; intervention not indicated Grade 2 - Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3 - Severe: Medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL Grade 4 - Life-threatening Grade 5 - Fatal. A serious AE is an AE that met one or more of the following criteria: * Death * Life-threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly/birth defect * Important medical events that required medical or surgical intervention to prevent one of the outcomes above.
Time frame: From first day of any study treatment (i.e., carfilzomib, carboplatin, or etoposide) up to 30 days after the last day of study treatment. The median overall duration of treatment was 16 weeks.
Population: All participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carfilzomib 20/20 mg/m² | Number of Participants With Adverse Events (AEs) | AEs leading to disocontinuation of study drug | 1 Participants |
| Carfilzomib 20/20 mg/m² | Number of Participants With Adverse Events (AEs) | Serious adverse events | 1 Participants |
| Carfilzomib 20/20 mg/m² | Number of Participants With Adverse Events (AEs) | Any adverse event | 5 Participants |
| Carfilzomib 20/20 mg/m² | Number of Participants With Adverse Events (AEs) | Fatal adverse events | 0 Participants |
| Carfilzomib 20/20 mg/m² | Number of Participants With Adverse Events (AEs) | Adverse events ≥ grade 3 | 3 Participants |
| Carfilzomib 20/27 mg/m² | Number of Participants With Adverse Events (AEs) | Any adverse event | 3 Participants |
| Carfilzomib 20/27 mg/m² | Number of Participants With Adverse Events (AEs) | AEs leading to disocontinuation of study drug | 0 Participants |
| Carfilzomib 20/27 mg/m² | Number of Participants With Adverse Events (AEs) | Serious adverse events | 1 Participants |
| Carfilzomib 20/27 mg/m² | Number of Participants With Adverse Events (AEs) | Adverse events ≥ grade 3 | 3 Participants |
| Carfilzomib 20/27 mg/m² | Number of Participants With Adverse Events (AEs) | Fatal adverse events | 0 Participants |
| Carfilzomib 20/36 mg/m² | Number of Participants With Adverse Events (AEs) | Fatal adverse events | 0 Participants |
| Carfilzomib 20/36 mg/m² | Number of Participants With Adverse Events (AEs) | Any adverse event | 3 Participants |
| Carfilzomib 20/36 mg/m² | Number of Participants With Adverse Events (AEs) | Adverse events ≥ grade 3 | 2 Participants |
| Carfilzomib 20/36 mg/m² | Number of Participants With Adverse Events (AEs) | Serious adverse events | 1 Participants |
| Carfilzomib 20/36 mg/m² | Number of Participants With Adverse Events (AEs) | AEs leading to disocontinuation of study drug | 0 Participants |
| Carfilzomib 20/45 mg/m² | Number of Participants With Adverse Events (AEs) | Adverse events ≥ grade 3 | 13 Participants |
| Carfilzomib 20/45 mg/m² | Number of Participants With Adverse Events (AEs) | AEs leading to disocontinuation of study drug | 3 Participants |
| Carfilzomib 20/45 mg/m² | Number of Participants With Adverse Events (AEs) | Any adverse event | 15 Participants |
| Carfilzomib 20/45 mg/m² | Number of Participants With Adverse Events (AEs) | Fatal adverse events | 0 Participants |
| Carfilzomib 20/45 mg/m² | Number of Participants With Adverse Events (AEs) | Serious adverse events | 7 Participants |
| Carfilzomib 20/56 mg/m² | Number of Participants With Adverse Events (AEs) | AEs leading to disocontinuation of study drug | 1 Participants |
| Carfilzomib 20/56 mg/m² | Number of Participants With Adverse Events (AEs) | Adverse events ≥ grade 3 | 4 Participants |
| Carfilzomib 20/56 mg/m² | Number of Participants With Adverse Events (AEs) | Fatal adverse events | 1 Participants |
| Carfilzomib 20/56 mg/m² | Number of Participants With Adverse Events (AEs) | Serious adverse events | 2 Participants |
| Carfilzomib 20/56 mg/m² | Number of Participants With Adverse Events (AEs) | Any adverse event | 5 Participants |
Secondary
Overall Survival (OS) - Phase 2
Overall Survival (OS) is defined as the time from randomization to the date of death. Overall survival was a specified secondary endpoint for the phase 2 portion of the study; since phase 2was not conducted, OS was not analyzed.
Time frame: 30 months
Population: Participants enrolled in phase 2
Secondary
Time of Maximum Plasma Concentration - Phase 2
Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.
Time frame: Cycle 1 Day 2
Population: Phase 2 participants
Other Pre-specified
Duration of Response
Duration of response (DOR) was calculated for participants who achieved a confirmed CR or PR. defined as the time from first evidence of confirmed PR/CR to disease progression or death due to any cause. Median DOR was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored. DOR was originally specified as a secondary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed, DOR was analyzed in phase 1b participants on an exploratory basis.
Time frame: From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.
Population: Participants with a confirmed response of PR or CR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib 20/20 mg/m² | Duration of Response | 4.9 months |
| Carfilzomib 20/27 mg/m² | Duration of Response | 5.0 months |
| Carfilzomib 20/36 mg/m² | Duration of Response | NA months |
| Carfilzomib 20/45 mg/m² | Duration of Response | 4.3 months |
| Carfilzomib 20/56 mg/m² | Duration of Response | 4.5 months |
| All Participants | Duration of Response | 4.8 months |
Other Pre-specified
Overall Response Rate
The overall response rate (ORR) was defined as the percentage of participants for whom the best overall confirmed response was either complete response (CR) or partial response (PR) assessed by the investigator according to RECIST v1.1 criteria. CR: Disappearance of all target and non-target lesions, no new lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.
Time frame: From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.
Population: All participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carfilzomib 20/20 mg/m² | Overall Response Rate | 60.0 percentage of participants |
| Carfilzomib 20/27 mg/m² | Overall Response Rate | 100.0 percentage of participants |
| Carfilzomib 20/36 mg/m² | Overall Response Rate | 66.7 percentage of participants |
| Carfilzomib 20/45 mg/m² | Overall Response Rate | 33.3 percentage of participants |
| Carfilzomib 20/56 mg/m² | Overall Response Rate | 33.3 percentage of participants |
| All Participants | Overall Response Rate | 46.9 percentage of participants |
Other Pre-specified
Progression-free Survival
Progression-free survival (PFS) was specified as a primary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed PFS was analyzed in phase 1b participants on an exploratory basis. PFS was defined as the time from the start of treatment to documented disease progression or death due to any cause, whichever occurred first. Disease progression was determined by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, defined as at least a 20% increase in the size of target lesions (absolute increase ≥ 5 mm), unequivocal progression of existing non-target lesions, or any new lesions. Median PFS was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored.
Time frame: From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.
Population: All participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carfilzomib 20/20 mg/m² | Progression-free Survival | 4.0 months |
| Carfilzomib 20/27 mg/m² | Progression-free Survival | 6.4 months |
| Carfilzomib 20/36 mg/m² | Progression-free Survival | 7.0 months |
| Carfilzomib 20/45 mg/m² | Progression-free Survival | 2.9 months |
| Carfilzomib 20/56 mg/m² | Progression-free Survival | 3.8 months |
| All Participants | Progression-free Survival | 4.4 months |