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

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ClinicalTrials.gov Identifier: NCT03512353
Recruitment Status : Terminated (Sponsor Decision)
First Posted : April 30, 2018
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsed or Refractory Multiple Myeloma
Interventions Drug: Dexamethasone
Drug: Carfilzomib
Enrollment 7
Recruitment Details This study was conducted at 10 centers in the United States.
Pre-assignment Details  
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 7
Received Treatment 6
Completed [1] 3
Not Completed 4
Reason Not Completed
Sponsor Decision             3
Death             1
[1]
Study completion is defined as participants who received 12 cycles of treatment and completed the safety follow-up visit.
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description

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 Number of Baseline Participants 6
Hide Baseline Analysis Population Description
The full analysis set includes all enrolled participants who received at least 1 dose of any study treatment (ie, carfilzomib or dexamethasone).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
62.5  (10.2)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
18 - 64 years
4
  66.7%
65 - 74 years
1
  16.7%
≥ 75 years
1
  16.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Black or African American
1
  16.7%
White
5
  83.3%
Eastern Cooperative Oncology Group (ECOG) Performance Scale   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
0 (Fully active)
5
  83.3%
1 (Restricted but ambulatory)
1
  16.7%
2 (Ambulatory but unable to work)
0
   0.0%
[1]
Measure Description:

A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction;

  1. = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
  2. = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about > 50% of waking hours;
  3. = Capable of only limited self-care, confined to bed or chair > 50% of waking hours;
  4. = Completely disabled, confined to bed or chair;
  5. = Dead.
Number of Prior Treatment Regimens  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
1 prior regimen
4
  66.7%
2 prior regimens
1
  16.7%
3 prior regimens
1
  16.7%
1.Primary Outcome
Title Number of Participants Who Completed 12 Cycles of Treatment
Hide Description [Not Specified]
Time Frame 12 cycles (each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
3
  50.0%
2.Primary Outcome
Title Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 12
Hide Description 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).
Time Frame Up to 12 cycles (each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percentage of expected dose
90.53  (9.70)
3.Primary Outcome
Title Relative Dose Intensity of Carfilzomib in Cycles 1 to 12
Hide Description 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).
Time Frame Up to 12 Cycles (each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percentage of dose intensity
89.85  (11.16)
4.Primary Outcome
Title Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12
Hide Description 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.
Time Frame Cycles 1 - 12 (each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any dose modification
6
 100.0%
Due to adverse event
3
  50.0%
Due to dose administration error
1
  16.7%
Per protocol
1
  16.7%
Due to weight change
2
  33.3%
Due to scheduling issues
5
  83.3%
5.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events
Hide Description

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.

Time Frame From the first dose of study drug until 30 days after the last dose (12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
6
 100.0%
Adverse events ≥ Grade 3
4
  66.7%
Serious adverse events
3
  50.0%
Leading to discontinuation of carfilzomib
0
   0.0%
Leading to discontinuation of dexamethasone
0
   0.0%
Fatal adverse events
1
  16.7%
Treatment-related adverse events
6
 100.0%
Treatment-related adverse events ≥ Grade 3
4
  66.7%
Treatment-related serious adverse events
3
  50.0%
Treatment-related fatal adverse events
1
  16.7%
6.Secondary Outcome
Title Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 6 and 7 to 12
Hide Description 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).
Time Frame Cycles 1-6 and 7-12 (each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants with available data in each time period
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percentage of expected dose
Cycles 1 - 6 Number Analyzed 6 participants
92.07  (8.70)
Cycles 7 - 12 Number Analyzed 5 participants
85.96  (12.98)
7.Secondary Outcome
Title Relative Dose Intensity of Carfilzomib in Cycles 1 to 6 and 7 to 12
Hide Description 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).
Time Frame Cycles 1 - 6 and 7 - 12 (each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants with available data in each time period
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percentage of dose intensity
Cycles 1 - 6 Number Analyzed 6 participants
92.80  (7.39)
Cycles 7 - 12 Number Analyzed 5 participants
85.96  (12.98)
8.Secondary Outcome
Title Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6
Hide Description 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.
Time Frame Cycles 1 - 6 (each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any dose modification
6
 100.0%
Due to adverse event
2
  33.3%
Due to dose administration error
1
  16.7%
Per protocol
1
  16.7%
Due to weight change
2
  33.3%
Due to scheduling issues
5
  83.3%
9.Secondary Outcome
Title Number of Participants With Carfilzomib Dose Modifications During Cycles 7 to 12
Hide Description 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.
Time Frame Cycles 7 - 12 (each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who received treatment during cycles 7 - 12
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
Any dose modification
4
  80.0%
Due to adverse event
3
  60.0%
Due to scheduling issues
1
  20.0%
10.Secondary Outcome
Title Number of Participants Who Discontinued Carfilzomib in Cycles 1 to 6 and 7 to 12
Hide Description Treatment discontinuation for all reasons in cycles 1 - 6 and cycles 7 - 12
Time Frame Cycles 1 - 6 and 7 - 12 (each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Discontinued during cycles 1 - 6 Number Analyzed 6 participants
1
  16.7%
Discontinued during cycles 7 - 12 Number Analyzed 5 participants
2
  40.0%
11.Secondary Outcome
Title 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)
Hide Description

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.

Time Frame Baseline (cycle 1 day 1) to cycle 12 day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Functioning -15.6  (15.6)
Role Functioning -16.7  (25.8)
Emotional Functioning -5.6  (15.5)
Cognitive Functioning 2.8  (12.6)
Social Functioning -19.4  (19.5)
Fatigue 9.3  (10.9)
Pain -8.3  (25.3)
Nausea and Vomiting 0.0  (10.5)
Global Health Status -5.6  (10.1)
Dyspnoea 22.2  (27.2)
Appetite Loss 5.6  (13.6)
Insomnia -5.6  (13.6)
Constipation 11.1  (27.2)
Diarrhoea -5.6  (25.1)
Financial Difficulties 5.6  (13.6)
12.Secondary Outcome
Title Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment
Hide Description

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.

Time Frame Baseline (cycle 1 day 1) and cycles 2 - 6
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who completed 12 cycles of treatment
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Functioning -16.9  (10.2)
Role Functioning -7.8  (18.4)
Emotional Functioning -13.9  (19.5)
Cognitive Functioning -4.4  (23.7)
Social Functioning -12.2  (15.8)
Fatigue 11.9  (9.0)
Pain -3.3  (20.8)
Nausea and Vomiting 10.0  (5.8)
Global Health Status -9.4  (9.5)
Dyspnoea 8.9  (7.7)
Appetite Loss 13.3  (13.3)
Insomnia -11.1  (3.9)
Constipation -4.4  (20.4)
Diarrhoea -2.2  (16.8)
Financial Difficulties 6.7  (24.0)
13.Secondary Outcome
Title 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
Hide Description

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.

Time Frame Cycle 7 day 1 and cycles 8 - 12
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who completed 12 cycles of treatment
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Functioning 6.2  (5.6)
Role Functioning -1.1  (5.1)
Emotional Functioning 1.1  (1.9)
Cognitive Functioning 13.3  (12.0)
Social Functioning 0.0  (6.7)
Fatigue 6.7  (16.0)
Pain 13.3  (12.0)
Nausea and Vomiting 6.7  (8.8)
Global Health Status 2.2  (1.9)
Dyspnoea 22.2  (13.9)
Appetite Loss 4.4  (7.7)
Insomnia 4.4  (7.7)
Constipation 0.0  (20.0)
Diarrhoea -2.2  (10.2)
Financial Difficulties -4.4  (3.9)
14.Secondary Outcome
Title Change From Baseline to Last Cycle of Treatment in EORTC QLQ Multiple Myeloma Module (MY-20) Scores
Hide Description

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.

Time Frame Baseline (cycle 1 day 1) and cycle 12 day 1
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All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
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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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Disease Symptoms -5.6  (17.9)
Side-effects of Treatment 6.5  (7.9)
Body Image -5.6  (13.6)
Future Perspective 1.9  (21.6)
15.Secondary Outcome
Title Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment
Hide Description

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.

Time Frame Baseline (cycle 1 day 1) and cycles 2 - 6
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Hide Analysis Population Description
Enrolled participants who completed 12 cycles of treatment
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Disease Symptoms -13.2  (16.4)
Side-effects of Treatment 10.6  (6.8)
Body Image -2.8  (4.8)
Future Perspective 6.1  (25.3)
16.Secondary Outcome
Title 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
Hide Description

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.

Time Frame Cycle 7 day 1 and cycles 8 - 12
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Hide Analysis Population Description
Enrolled participants who completed 12 cycles of treatment
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Disease Symptoms 8.2  (7.6)
Side-effects of Treatment -3.8  (3.8)
Body Image -17.8  (20.4)
Future Perspective 3.0  (7.1)
17.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description

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).

Time Frame Disease assessments were performed every 28 days up to 12 months from enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.3
(35.9 to 99.6)
18.Secondary Outcome
Title Overall Response Rate (ORR) After 6 Cycles
Hide Description

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).

Time Frame Disease assessments were performed every 28 days up to 6 cycles of treatment (each cycle was 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.3
(35.9 to 99.6)
19.Secondary Outcome
Title Overall Response Rate (ORR) by Prior Lines of Therapy
Hide Description

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).

Time Frame Disease assessments were performed every 28 days up to 12 months from enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title 1 Prior Line of Therapy 2+ Prior Lines of Therapy
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Participants with 1 prior line of therapy for multiple myeloma.
Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Overall Number of Participants Analyzed 4 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.0
(19.4 to 99.4)
100.0
(15.8 to 100.0)
20.Secondary Outcome
Title Percentage of Participants With Progression-free Survival (PFS) Events at 12 Months
Hide Description

Progression-free survival events include disease progression or death due to any cause.

Disease progression was determined by the Investigator according to IMWG criteria.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description:

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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of participants
50.0
21.Secondary Outcome
Title Percentage of Participants With PFS Events by Prior Lines of Therapy
Hide Description

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.

Time Frame Disease assessments were performed every 28 days up to 12 months from enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and treated participants
Arm/Group Title 1 Prior Line of Therapy 2+ Prior Lines of Therapy
Hide Arm/Group Description:
Participants with 1 prior line of therapy for multiple myeloma.
Participants with ≥ 2 prior lines of therapy for multiple myeloma.
Overall Number of Participants Analyzed 4 2
Measure Type: Number
Unit of Measure: percentage of participants
50.0 50.0
Time Frame 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)
Adverse Event Reporting Description 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.
 
Arm/Group Title Carfilzomib Plus Dexamethasone
Hide Arm/Group Description

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.

All-Cause Mortality
Carfilzomib Plus Dexamethasone
Affected / at Risk (%)
Total   1/7 (14.29%) 
Hide Serious Adverse Events
Carfilzomib Plus Dexamethasone
Affected / at Risk (%)
Total   3/6 (50.00%) 
Cardiac disorders   
Cardiac arrest  1  1/6 (16.67%) 
Gastrointestinal disorders   
Large intestine perforation  1  1/6 (16.67%) 
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/6 (16.67%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carfilzomib Plus Dexamethasone
Affected / at Risk (%)
Total   6/6 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  2/6 (33.33%) 
Cardiac disorders   
Sinus tachycardia  1  1/6 (16.67%) 
Supraventricular extrasystoles  1  1/6 (16.67%) 
Tachycardia  1  1/6 (16.67%) 
Ear and labyrinth disorders   
Tinnitus  1  1/6 (16.67%) 
Vertigo  1  1/6 (16.67%) 
Eye disorders   
Conjunctival haemorrhage  1  1/6 (16.67%) 
Vision blurred  1  1/6 (16.67%) 
Gastrointestinal disorders   
Abdominal pain  1  1/6 (16.67%) 
Constipation  1  1/6 (16.67%) 
Diarrhoea  1  3/6 (50.00%) 
Dyspepsia  1  1/6 (16.67%) 
Dysphagia  1  1/6 (16.67%) 
Nausea  1  3/6 (50.00%) 
Vomiting  1  2/6 (33.33%) 
General disorders   
Asthenia  1  1/6 (16.67%) 
Chest discomfort  1  1/6 (16.67%) 
Chest pain  1  1/6 (16.67%) 
Chills  1  1/6 (16.67%) 
Fatigue  1  2/6 (33.33%) 
Oedema peripheral  1  1/6 (16.67%) 
Infections and infestations   
Diverticulitis  1  1/6 (16.67%) 
Sinusitis  1  1/6 (16.67%) 
Skin infection  1  1/6 (16.67%) 
Tooth infection  1  1/6 (16.67%) 
Upper respiratory tract infection  1  2/6 (33.33%) 
Injury, poisoning and procedural complications   
Contusion  1  1/6 (16.67%) 
Fractured coccyx  1  1/6 (16.67%) 
Rib fracture  1  1/6 (16.67%) 
Scapula fracture  1  1/6 (16.67%) 
Investigations   
Platelet count decreased  1  1/6 (16.67%) 
Weight decreased  1  1/6 (16.67%) 
White blood cell count decreased  1  1/6 (16.67%) 
Metabolism and nutrition disorders   
Decreased appetite  1  2/6 (33.33%) 
Dehydration  1  1/6 (16.67%) 
Hypokalaemia  1  2/6 (33.33%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  1/6 (16.67%) 
Nervous system disorders   
Dizziness  1  2/6 (33.33%) 
Dizziness exertional  1  1/6 (16.67%) 
Headache  1  2/6 (33.33%) 
Paraesthesia  1  1/6 (16.67%) 
Psychiatric disorders   
Confusional state  1  1/6 (16.67%) 
Depression  1  1/6 (16.67%) 
Insomnia  1  2/6 (33.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/6 (66.67%) 
Dysphonia  1  1/6 (16.67%) 
Dyspnoea  1  2/6 (33.33%) 
Dyspnoea exertional  1  1/6 (16.67%) 
Emphysema  1  1/6 (16.67%) 
Hiccups  1  1/6 (16.67%) 
Nasal congestion  1  1/6 (16.67%) 
Sinus pain  1  1/6 (16.67%) 
Vascular disorders   
Embolism  1  1/6 (16.67%) 
Hypertension  1  1/6 (16.67%) 
Hypotension  1  2/6 (33.33%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Because of the limited sample size, no meaningful conclusions on the study objectives can be made.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03512353    
Other Study ID Numbers: 20170596
First Submitted: April 2, 2018
First Posted: April 30, 2018
Results First Submitted: December 14, 2020
Results First Posted: January 8, 2021
Last Update Posted: January 8, 2021