Trial Outcomes & Findings for A Study of Carfilzomib Plus Dexamethasone in Adults With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers (NCT NCT03512353)

NCT ID: NCT03512353

Last Updated: 2021-01-08

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

12 cycles (each cycle is 28 days)

Results posted on

2021-01-08

Participant Flow

This study was conducted at 10 centers in the United States.

Participant milestones

Participant milestones
Measure	Carfilzomib Plus Dexamethasone Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
Overall Study STARTED	7
Overall Study Received Treatment	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Carfilzomib Plus Dexamethasone Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
Overall Study Sponsor Decision	3
Overall Study Death	1

Baseline Characteristics

A Study of Carfilzomib Plus Dexamethasone in Adults With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
Age, Continuous	62.5 years STANDARD_DEVIATION 10.2 • n=5 Participants
Age, Customized 18 - 64 years	4 Participants n=5 Participants
Age, Customized 65 - 74 years	1 Participants n=5 Participants
Age, Customized ≥ 75 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 (Fully active)	5 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Scale 1 (Restricted but ambulatory)	1 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Scale 2 (Ambulatory but unable to work)	0 Participants n=5 Participants
Number of Prior Treatment Regimens 1 prior regimen	4 Participants n=5 Participants
Number of Prior Treatment Regimens 2 prior regimens	1 Participants n=5 Participants
Number of Prior Treatment Regimens 3 prior regimens	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 cycles (each cycle is 28 days)

Population: All enrolled and treated participants

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Number of Participants Who Completed 12 Cycles of Treatment	3 Participants	—

PRIMARY outcome

Timeframe: Up to 12 cycles (each cycle is 28 days)

Population: All enrolled and treated participants

Percentage of expected dose of carfilzomib is defined as the percentage of actual cumulative dose (mg/m²) received by the participant relative to the full intended cumulative dose (mg/m²).

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 12	90.53 percentage of expected dose Standard Deviation 9.70	—

PRIMARY outcome

Timeframe: Up to 12 Cycles (each cycle is 28 days)

Population: All enrolled and treated participants

Relative dose intensity = actual dose intensity / planned dose intensity \* 100, where dose intensity is the cumulative dose (mg) divided by the duration of the study drug administration (weeks).

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Relative Dose Intensity of Carfilzomib in Cycles 1 to 12	89.85 percentage of dose intensity Standard Deviation 11.16	—

PRIMARY outcome

Timeframe: Cycles 1 - 12 (each cycle is 28 days)

Population: All enrolled and treated participants

Dose modification includes dosage adjustments, delays or discontinuations. A participant is counted only once for a reason category if there were multiple occurrences for the same reason. Participants may be counted in more than one category.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12 Any dose modification	6 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12 Due to adverse event	3 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12 Due to dose administration error	1 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12 Per protocol	1 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12 Due to weight change	2 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12 Due to scheduling issues	5 Participants	—

PRIMARY outcome

Timeframe: From the first dose of study drug until 30 days after the last dose (12 months)

Population: All enrolled and treated participants

Treatment-emergent adverse events are defined as any adverse event with an onset date from the first dose through 30 days after the last dose of any study drug. Treatment-emergent related adverse events are adverse events considered related to at least one study drug by the investigator. Adverse events were graded using Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03, where Grade 1: Mild (asymptomatic or mild symptoms) Grade 2: Moderate (minimal, local or noninvasive intervention indicated) Grade 3: Severe (severe) or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated) Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Number of Participants With Treatment-emergent Adverse Events Treatment-related adverse events ≥ Grade 3	4 Participants	—
Number of Participants With Treatment-emergent Adverse Events Any adverse event	6 Participants	—
Number of Participants With Treatment-emergent Adverse Events Adverse events ≥ Grade 3	4 Participants	—
Number of Participants With Treatment-emergent Adverse Events Serious adverse events	3 Participants	—
Number of Participants With Treatment-emergent Adverse Events Leading to discontinuation of carfilzomib	0 Participants	—
Number of Participants With Treatment-emergent Adverse Events Leading to discontinuation of dexamethasone	0 Participants	—
Number of Participants With Treatment-emergent Adverse Events Fatal adverse events	1 Participants	—
Number of Participants With Treatment-emergent Adverse Events Treatment-related adverse events	6 Participants	—
Number of Participants With Treatment-emergent Adverse Events Treatment-related serious adverse events	3 Participants	—
Number of Participants With Treatment-emergent Adverse Events Treatment-related fatal adverse events	1 Participants	—

SECONDARY outcome

Timeframe: Cycles 1-6 and 7-12 (each cycle is 28 days)

Population: All enrolled and treated participants with available data in each time period

Percentage of expected dose of carfilzomib is defined as the percentage of actual cumulative dose (mg/m²) received by the participant relative to the full intended cumulative dose (mg/m²).

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 6 and 7 to 12 Cycles 1 - 6	92.07 percentage of expected dose Standard Deviation 8.70	—
Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 6 and 7 to 12 Cycles 7 - 12	85.96 percentage of expected dose Standard Deviation 12.98	—

SECONDARY outcome

Timeframe: Cycles 1 - 6 and 7 - 12 (each cycle is 28 days)

Population: All enrolled and treated participants with available data in each time period

Relative dose intensity = actual dose intensity / planned dose intensity \* 100, where dose intensity is the cumulative dose (mg) divided by the duration of the study drug administration (weeks).

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Relative Dose Intensity of Carfilzomib in Cycles 1 to 6 and 7 to 12 Cycles 1 - 6	92.80 percentage of dose intensity Standard Deviation 7.39	—
Relative Dose Intensity of Carfilzomib in Cycles 1 to 6 and 7 to 12 Cycles 7 - 12	85.96 percentage of dose intensity Standard Deviation 12.98	—

SECONDARY outcome

Timeframe: Cycles 1 - 6 (each cycle is 28 days)

Population: All enrolled and treated participants

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6 Any dose modification	6 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6 Due to adverse event	2 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6 Due to dose administration error	1 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6 Per protocol	1 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6 Due to weight change	2 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6 Due to scheduling issues	5 Participants	—

SECONDARY outcome

Timeframe: Cycles 7 - 12 (each cycle is 28 days)

Population: Enrolled participants who received treatment during cycles 7 - 12

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=5 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Number of Participants With Carfilzomib Dose Modifications During Cycles 7 to 12 Any dose modification	4 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 7 to 12 Due to adverse event	3 Participants	—
Number of Participants With Carfilzomib Dose Modifications During Cycles 7 to 12 Due to scheduling issues	1 Participants	—

SECONDARY outcome

Timeframe: Cycles 1 - 6 and 7 - 12 (each cycle is 28 days)

Population: All enrolled and treated participants

Treatment discontinuation for all reasons in cycles 1 - 6 and cycles 7 - 12

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Number of Participants Who Discontinued Carfilzomib in Cycles 1 to 6 and 7 to 12 Discontinued during cycles 1 - 6	1 Participants	—
Number of Participants Who Discontinued Carfilzomib in Cycles 1 to 6 and 7 to 12 Discontinued during cycles 7 - 12	2 Participants	—

SECONDARY outcome

Timeframe: Baseline (cycle 1 day 1) to cycle 12 day 1

Population: All enrolled and treated participants

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) is a 30-item questionnaire used to assess the overall quality of life in cancer patients. EORTC QLQ-C30 was administered on day 1 of each treatment cycle. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact). For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Physical Functioning	-15.6 scores on a scale Standard Deviation 15.6	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Role Functioning	-16.7 scores on a scale Standard Deviation 25.8	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Emotional Functioning	-5.6 scores on a scale Standard Deviation 15.5	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Cognitive Functioning	2.8 scores on a scale Standard Deviation 12.6	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Social Functioning	-19.4 scores on a scale Standard Deviation 19.5	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Fatigue	9.3 scores on a scale Standard Deviation 10.9	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Pain	-8.3 scores on a scale Standard Deviation 25.3	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Nausea and Vomiting	0.0 scores on a scale Standard Deviation 10.5	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Global Health Status	-5.6 scores on a scale Standard Deviation 10.1	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Dyspnoea	22.2 scores on a scale Standard Deviation 27.2	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Appetite Loss	5.6 scores on a scale Standard Deviation 13.6	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Insomnia	-5.6 scores on a scale Standard Deviation 13.6	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Constipation	11.1 scores on a scale Standard Deviation 27.2	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Diarrhoea	-5.6 scores on a scale Standard Deviation 25.1	—
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) Financial Difficulties	5.6 scores on a scale Standard Deviation 13.6	—

SECONDARY outcome

Timeframe: Baseline (cycle 1 day 1) and cycles 2 - 6

Population: Enrolled participants who completed 12 cycles of treatment

EORTC QLQ-C30 was administered on day 1 of each treatment cycle. EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact). For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the average score from cycles 2 to 6 and the score on cycle 1 day 1.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=3 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Physical Functioning	-16.9 scores on a scale Standard Deviation 10.2	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Role Functioning	-7.8 scores on a scale Standard Deviation 18.4	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Emotional Functioning	-13.9 scores on a scale Standard Deviation 19.5	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Cognitive Functioning	-4.4 scores on a scale Standard Deviation 23.7	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Social Functioning	-12.2 scores on a scale Standard Deviation 15.8	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Fatigue	11.9 scores on a scale Standard Deviation 9.0	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Pain	-3.3 scores on a scale Standard Deviation 20.8	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Nausea and Vomiting	10.0 scores on a scale Standard Deviation 5.8	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Global Health Status	-9.4 scores on a scale Standard Deviation 9.5	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Dyspnoea	8.9 scores on a scale Standard Deviation 7.7	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Appetite Loss	13.3 scores on a scale Standard Deviation 13.3	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Insomnia	-11.1 scores on a scale Standard Deviation 3.9	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Constipation	-4.4 scores on a scale Standard Deviation 20.4	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Diarrhoea	-2.2 scores on a scale Standard Deviation 16.8	—
Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Financial Difficulties	6.7 scores on a scale Standard Deviation 24.0	—

SECONDARY outcome

Timeframe: Cycle 7 day 1 and cycles 8 - 12

Population: Enrolled participants who completed 12 cycles of treatment

EORTC QLQ-C30 was administered on day 1 of each treatment cycle. EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact). For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicates an improvement in symptoms. Change was calculated as the difference in the average score from cycles 8 to 12 and the score on cycle 7 day 1.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=3 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Physical Functioning	6.2 scores on a scale Standard Deviation 5.6	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Role Functioning	-1.1 scores on a scale Standard Deviation 5.1	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Emotional Functioning	1.1 scores on a scale Standard Deviation 1.9	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Cognitive Functioning	13.3 scores on a scale Standard Deviation 12.0	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Social Functioning	0.0 scores on a scale Standard Deviation 6.7	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Fatigue	6.7 scores on a scale Standard Deviation 16.0	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Pain	13.3 scores on a scale Standard Deviation 12.0	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Nausea and Vomiting	6.7 scores on a scale Standard Deviation 8.8	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Global Health Status	2.2 scores on a scale Standard Deviation 1.9	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Dyspnoea	22.2 scores on a scale Standard Deviation 13.9	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Appetite Loss	4.4 scores on a scale Standard Deviation 7.7	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Insomnia	4.4 scores on a scale Standard Deviation 7.7	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Constipation	0.0 scores on a scale Standard Deviation 20.0	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Diarrhoea	-2.2 scores on a scale Standard Deviation 10.2	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Financial Difficulties	-4.4 scores on a scale Standard Deviation 3.9	—

SECONDARY outcome

Timeframe: Baseline (cycle 1 day 1) and cycle 12 day 1

Population: All enrolled and treated participants

EORTC QLQ-MY20 is a 20-item questionnaire used in clinical research to assess health-related quality of life in multiple myeloma patients. Questions are answered on a 4-point scale from 1 'Not at All' to 4 'Very Much'. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). Domain scores are calculated as averages and transformed to range from 0 to 100. For the Disease symptoms and side-effects of treatments scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. For the body image and future perspectives scales a higher score represents a higher level of functioning, and a positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Change From Baseline to Last Cycle of Treatment in EORTC QLQ Multiple Myeloma Module (MY-20) Scores Disease Symptoms	-5.6 scores on a scale Standard Deviation 17.9	—
Change From Baseline to Last Cycle of Treatment in EORTC QLQ Multiple Myeloma Module (MY-20) Scores Side-effects of Treatment	6.5 scores on a scale Standard Deviation 7.9	—
Change From Baseline to Last Cycle of Treatment in EORTC QLQ Multiple Myeloma Module (MY-20) Scores Body Image	-5.6 scores on a scale Standard Deviation 13.6	—
Change From Baseline to Last Cycle of Treatment in EORTC QLQ Multiple Myeloma Module (MY-20) Scores Future Perspective	1.9 scores on a scale Standard Deviation 21.6	—

SECONDARY outcome

Timeframe: Baseline (cycle 1 day 1) and cycles 2 - 6

Population: Enrolled participants who completed 12 cycles of treatment

EORTC QLQ-MY20 is a 20-item questionnaire used in clinical research to assess health-related quality of life in multiple myeloma patients. Questions are answered on a 4-point scale from 1 'Not at All' to 4 'Very Much'. The QLQ-MY20 includes four domains (Disease Symptoms, Side-effects of Treatment, Body Image and Future Perspective). Domain scores are calculated as averages and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. For the body image and future perspectives scales a higher score represents a higher level of functioning, and a positive change from baseline indicates improvement. Change from baseline is the difference in the average score from cycles 2 to 6 and the score on cycle 1 day 1.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=3 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Disease Symptoms	-13.2 scores on a scale Standard Deviation 16.4	—
Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Side-effects of Treatment	10.6 scores on a scale Standard Deviation 6.8	—
Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Body Image	-2.8 scores on a scale Standard Deviation 4.8	—
Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment Future Perspective	6.1 scores on a scale Standard Deviation 25.3	—

SECONDARY outcome

Timeframe: Cycle 7 day 1 and cycles 8 - 12

Population: Enrolled participants who completed 12 cycles of treatment

EORTC QLQ-MY20 is a 20-item questionnaire used in clinical research to assess health-related quality of life in multiple myeloma patients. Questions are answered on a 4-point scale from 1 'Not at All' to 4 'Very Much'. The QLQ-MY20 includes four domains (Disease Symptoms, Side- Effects of Treatment, Body Image and Future Perspective). Domain scores are calculated as averages and transformed to range from 0 to 100. For the disease symptoms and side effects of treatments scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. For the body image and future perspectives scales a higher score represents a higher level of functioning, and a positive change from baseline indicates improvement. Change was calculated as the difference in the average score from cycles 8 to 12 and the score on cycle 7 day 1.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=3 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Change From Cycle 7 Day 1 in Average EORTC QLQ-MY20 Scores Over Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Disease Symptoms	8.2 scores on a scale Standard Deviation 7.6	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-MY20 Scores Over Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Side-effects of Treatment	-3.8 scores on a scale Standard Deviation 3.8	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-MY20 Scores Over Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Body Image	-17.8 scores on a scale Standard Deviation 20.4	—
Change From Cycle 7 Day 1 in Average EORTC QLQ-MY20 Scores Over Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment Future Perspective	3.0 scores on a scale Standard Deviation 7.1	—

SECONDARY outcome

Timeframe: Disease assessments were performed every 28 days up to 12 months from enrollment.

Population: All enrolled and treated participants

Disease response and progression were determined using International Myeloma Working Group Uniform Response Criteria (IMWG-URC) 2016, assessed by the Investigator. Per IMWG, determination of disease response requires: serum free light chain (SFLC), serum and urine protein electrophoresis (SPEP, UPEP, respectively), serum and urine immunofixation (SIFE, UIFE, respectively), bone marrow aspirate (for complete response confirmation), corrected calcium (cCa), and plasmacytoma evaluation, if present at screening. Best overall response is defined as a participant's best response during the study. Overall response rate is defined as the percentage of participants achieving a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Overall Response Rate (ORR)	83.3 percentage of participants Interval 35.9 to 99.6	—

SECONDARY outcome

Timeframe: Disease assessments were performed every 28 days up to 6 cycles of treatment (each cycle was 28 days)

Population: All enrolled and treated participants

Disease response and progression were determined using International Myeloma Working Group Uniform Response Criteria (IMWG-URC) 2016, assessed by the Investigator. Per IMWG, determination of disease response requires: serum free light chain (SFLC), serum and urine protein electrophoresis (SPEP, UPEP, respectively), serum and urine immunofixation (SIFE, UIFE, respectively), bone marrow aspirate (for CR confirmation), corrected calcium, and plasmacytoma evaluation, if present at screening. Overall response rate after 6 cycles is defined as the percentage of participants achieving a best overall response during the first 6 treatment cycles of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Overall Response Rate (ORR) After 6 Cycles	83.3 percentage of participants Interval 35.9 to 99.6	—

SECONDARY outcome

Timeframe: Disease assessments were performed every 28 days up to 12 months from enrollment.

Population: All enrolled and treated participants

Disease response and progression were determined using International Myeloma Working Group Uniform Response Criteria (IMWG-URC) 2016, assessed by the Investigator. Per IMWG, determination of disease response requires: serum free light chain (SFLC), serum and urine protein electrophoresis (SPEP, UPEP, respectively), serum and urine immunofixation (SIFE, UIFE, respectively), bone marrow aspirate (for CR confirmation), corrected calcium, and plasmacytoma evaluation, if present at screening. Best overall response is defined as a participant's best response during the study. Overall response rate is defined as the percentage of participants achieving a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=4 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy n=2 Participants Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Overall Response Rate (ORR) by Prior Lines of Therapy	75.0 percentage of participants Interval 19.4 to 99.4	100.0 percentage of participants Interval 15.8 to 100.0

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled and treated participants

Progression-free survival events include disease progression or death due to any cause. Disease progression was determined by the Investigator according to IMWG criteria.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=6 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Percentage of Participants With Progression-free Survival (PFS) Events at 12 Months	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Disease assessments were performed every 28 days up to 12 months from enrollment.

Population: All enrolled and treated participants

Progression-free survival (PFS) events include disease progression or death due to any cause. Disease progression was determined by the Investigator according to IMWG criteria.

Outcome measures

Outcome measures
Measure	Carfilzomib Plus Dexamethasone n=4 Participants Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.	2+ Prior Lines of Therapy n=2 Participants Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Percentage of Participants With PFS Events by Prior Lines of Therapy	50.0 percentage of participants	50.0 percentage of participants

Adverse Events

Carfilzomib Plus Dexamethasone

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Carfilzomib Plus Dexamethasone n=6 participants at risk Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
Cardiac disorders Cardiac arrest	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestine perforation	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Carfilzomib Plus Dexamethasone n=6 participants at risk Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
Blood and lymphatic system disorders Anaemia	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinus tachycardia	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Supraventricular extrasystoles	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Tachycardia	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Tinnitus	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Conjunctival haemorrhage	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Vision blurred	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	50.0% 3/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	50.0% 3/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Asthenia	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest discomfort	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest pain	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chills	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Fatigue	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema peripheral	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Diverticulitis	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sinusitis	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Skin infection	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Tooth infection	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fractured coccyx	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Rib fracture	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Scapula fracture	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Platelet count decreased	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Weight decreased	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations White blood cell count decreased	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness exertional	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Depression	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 4/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Emphysema	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus pain	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Embolism	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	16.7% 1/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypotension	33.3% 2/6 • All cause mortality - from enrollment to end of study (13 months) Adverse Events - From the first dose of study drug until 30 days after the last dose (12 months) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER