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Sponsor Decision
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The primary objective was to describe the safety profile of carfilzomib plus dexamethasone regimen in adults with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy at study entry.
This is a phase 2, multicenter, open-label study in adults with RRMM in US community oncology centers. Adults with 1-3 prior lines of therapy at study entry are eligible to be screened for participation. Patients refractory to their last line of treatment are eligible to participate as long as their last line of treatment did not include a proteasome inhibitor (PI). The study will consist of a screening period of up to 28 days for bone marrow assessments and up to 21 days for all other assessments, up to 12 cycles of treatment, and a 30-day safety follow-up period following the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carfilzomib Plus Dexamethasone | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone will be taken 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 1-6, and at a dose 40 mg once-daily on days 1, 8, 15 of cycles 7-12. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed 12 Cycles of Treatment | 12 cycles (each cycle is 28 days) | |
| Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 12 | 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). | Up to 12 cycles (each cycle is 28 days) |
| Relative Dose Intensity of Carfilzomib in Cycles 1 to 12 | 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). | Up to 12 Cycles (each cycle is 28 days) |
| Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12 | 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. | Cycles 1 - 12 (each cycle is 28 days) |
| Number of Participants With Treatment-emergent Adverse Events | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 6 and 7 to 12 | 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). | Cycles 1-6 and 7-12 (each cycle is 28 days) |
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Inclusion Criteria:
Subject has provided informed consent prior to initiation of any study specific activities/procedures.
Males or females greater than or equal to 18 years of age.
Relapsed MM after last treatment or refractory while receiving non-proteasome inhibitor therapy.
Measurable disease with at least 1 of the following assessed within 21 days prior to enrollment:
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
Subjects must have at least partial response (PR) to at least 1 line of prior therapy.
Subjects must have received at least 1 but not more than 3 prior lines of therapy for MM (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy).
Prior therapy with a proteasome inhibitor (PI) is allowed as long as the subject had at least a PR to most recent therapy with PI, was not removed due to toxicity (except for neuropathy), did not relapse within 60 days from discontinuation of PI, and will have at least a 6-month PI treatment-free interval from last dose received until enrollment. (Subjects may receive maintenance therapy with drugs that are not PI during this 6-month PI treatment-free interval).
Exclusion Criteria:
Waldenström macroglobulinemia.
Multiple myeloma of IgM subtype.
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
History of plasma cell leukemia.
Primary amyloidosis (patients with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met).
Subjects with nephrotic range proteinuria (greater than or equal to 3 g albumin for 24 hours urine OR greater than or equal to 2 g albumin/1 g of creatinine on a random urine specimen).
Myelodysplastic syndrome.
History of other malignancy within the past 5 years, with the following exceptions:
Known human immunodeficiency virus (HIV) infection, hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response following antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response with antiviral therapy directed at hepatitis B are allowed).
Acute or chronic graft-versus-host disease (any grade).
Acute active infection requiring systemic antibiotics, antifungal, antiviral (except antiviral therapy directed at hepatitis B) agents within 14 days prior to enrollment.
Known cirrhosis.
Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to enrollment.
Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment.
Uncontrolled hypertension, defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg. Subjects with controlled hypertension are eligible.
Hepatic dysfunction within 21 days prior to enrollment: bilirubin 1.5 times the upper limit of normal (ULN) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 3 times the ULN
Active congestive heart failure with or without reduced ejection fraction (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT interval (QTc) of greater than 470 msec, pericardial disease, myocardial infarction within 4 months prior to enrollment.
Known chronic obstructive pulmonary disease.
Known interstitial pneumonitis.
Immunotherapy within 21 days prior to enrollment.
Chemotherapy with approved anticancer therapeutic within 21 days prior to enrollment.
Glucocorticoid therapy (prednisone greater than 30 mg/day or equivalent) within 14 days prior to enrollment.
Focal radiation therapy within 7 days prior to enrollment. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (ie, prior radiation must have been to less than 30% of the bone marrow).
Major surgery (except kyphoplasty) within 28 days prior to enrollment.
Autologous or allogeneic stem cell transplant within 90 days prior to enrollment.
Contraindication to dexamethasone.
Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib).
Intolerance to intravenous (IV) hydration.
Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
Hepatic dysfunction within 21 days prior to enrollment: bilirubin greater than or equal to 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 3 times the ULN.
Left ventricular ejection fraction less than 40% assessed by transthoracic echocardiogram.
Severe valvular disease assessed by transthoracic echocardiogram.
Severe right-ventricular dysfunction assessed by transthoracic echocardiogram.
Right-ventricular systolic pressure greater than 40 mm Hg assessed by transthoracic echocardiogram.
Screening absolute neutrophil count (ANC) should be independent of growth factor support for greater than or equal to 1 week.
Hemoglobin less than 80 g/L within 21 days prior to enrollment. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.
Platelet count < 50 x 10^9/L (≤ 30 x 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to enrollment. Subjects should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
Estimated glomerular filtration rate (GFR) less than 30 mL/min/1.73 m^2 (per the Chronic Kidney Disease Epidemiology Collaboration formula) within 21 days prior to enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Palm Springs | California | 92262 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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This study was conducted at 10 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2019 | Dec 14, 2020 |
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| Carfilzomib | Drug | Carfilzomib will be administered at 20 mg/m² on days 1 and 2 of the first cycle. After that, carfilzomib will be administered at 56 mg/m² on days 8, 9, 15, and 16 of the first cycle, and then on days 1, 2, 8, 9, 15, and 16 on each 28-day cycle for the cycles 2 through 6. Starting with cycle 7 through cycle 12, carfilzomib will be administered at 70 mg/m² on days 1, 8, and 15 of each 28-day cycle. All |
|
|
| From the first dose of study drug until 30 days after the last dose (12 months) |
| Relative Dose Intensity of Carfilzomib in Cycles 1 to 6 and 7 to 12 |
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). |
| Cycles 1 - 6 and 7 - 12 (each cycle is 28 days) |
| Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6 | 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. | Cycles 1 - 6 (each cycle is 28 days) |
| Number of Participants With Carfilzomib Dose Modifications During Cycles 7 to 12 | 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. | Cycles 7 - 12 (each cycle is 28 days) |
| Number of Participants Who Discontinued Carfilzomib in Cycles 1 to 6 and 7 to 12 | Treatment discontinuation for all reasons in cycles 1 - 6 and cycles 7 - 12 | Cycles 1 - 6 and 7 - 12 (each cycle is 28 days) |
| 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) | 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. | Baseline (cycle 1 day 1) to cycle 12 day 1 |
| Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in 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. | Baseline (cycle 1 day 1) and cycles 2 - 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 | 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. | Cycle 7 day 1 and cycles 8 - 12 |
| Change From Baseline to Last Cycle of Treatment in EORTC QLQ Multiple Myeloma Module (MY-20) Scores | 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. | Baseline (cycle 1 day 1) and cycle 12 day 1 |
| Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in 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. | Baseline (cycle 1 day 1) and cycles 2 - 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 | 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. | Cycle 7 day 1 and cycles 8 - 12 |
| Overall Response Rate (ORR) | 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). | Disease assessments were performed every 28 days up to 12 months from enrollment. |
| Overall Response Rate (ORR) After 6 Cycles | 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). | Disease assessments were performed every 28 days up to 6 cycles of treatment (each cycle was 28 days) |
| Overall Response Rate (ORR) by Prior Lines of Therapy | 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). | Disease assessments were performed every 28 days up to 12 months from enrollment. |
| Percentage of Participants With Progression-free Survival (PFS) Events at 12 Months | Progression-free survival events include disease progression or death due to any cause. Disease progression was determined by the Investigator according to IMWG criteria. | 12 months |
| Percentage of Participants With PFS Events by Prior Lines of Therapy | 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. | Disease assessments were performed every 28 days up to 12 months from enrollment. |
| Riverside |
| California |
| 92501 |
| United States |
| Research Site | Glenwood Springs | Colorado | 81601 | United States |
| Research Site | Boynton Beach | Florida | 33426 | United States |
| Research Site | Orange City | Florida | 32763 | United States |
| Research Site | Pensacola | Florida | 32504 | United States |
| Research Site | Honolulu | Hawaii | 96813 | United States |
| Research Site | River Forest | Illinois | 60305 | United States |
| Research Site | Tinley Park | Illinois | 60487 | United States |
| Research Site | Indianapolis | Indiana | 46260 | United States |
| Research Site | Paducah | Kentucky | 42003 | United States |
| Research Site | Bethesda | Maryland | 20817 | United States |
| Research Site | Midland | Michigan | 48640 | United States |
| Research Site | Jackson | Mississippi | 39202 | United States |
| Research Site | Lincoln | Nebraska | 68506 | United States |
| Research Site | Florham Park | New Jersey | 07932 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Hendersonville | North Carolina | 28792 | United States |
| Research Site | Pinehurst | North Carolina | 28374 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Zanesville | Ohio | 43701 | United States |
| Research Site | Charleston | South Carolina | 29414 | United States |
| Research Site | Rock Hill | South Carolina | 29732 | United States |
| Research Site | Corpus Christi | Texas | 78412 | United States |
| Research Site | Fort Worth | Texas | 76104 | United States |
| Research Site | Houston | Texas | 77057 | United States |
| Research Site | Houston | Texas | 77090 | United States |
| Research Site | Ogden | Utah | 84405 | United States |
| Research Site | Fredericksburg | Virginia | 22408 | United States |
| Research Site | Yakima | Washington | 98902 | United States |
| Received Treatment |
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| COMPLETED | Study completion is defined as participants who received 12 cycles of treatment and completed the safety follow-up visit. |
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| NOT COMPLETED |
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The full analysis set includes all enrolled participants who received at least 1 dose of any study treatment (ie, carfilzomib or dexamethasone).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Scale | A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction;
| Count of Participants | Participants |
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| Number of Prior Treatment Regimens | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Number of Participants Who Completed 12 Cycles of Treatment | All enrolled and treated participants | Posted | Count of Participants | Participants | 12 cycles (each cycle is 28 days) |
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| Primary | Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 12 | 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). | All enrolled and treated participants | Posted | Mean | Standard Deviation | percentage of expected dose | Up to 12 cycles (each cycle is 28 days) |
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| Primary | Relative Dose Intensity of Carfilzomib in Cycles 1 to 12 | 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). | All enrolled and treated participants | Posted | Mean | Standard Deviation | percentage of dose intensity | Up to 12 Cycles (each cycle is 28 days) |
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| Primary | Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12 | 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. | All enrolled and treated participants | Posted | Count of Participants | Participants | Cycles 1 - 12 (each cycle is 28 days) |
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| Primary | Number of Participants With Treatment-emergent Adverse Events | 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. | All enrolled and treated participants | Posted | Count of Participants | Participants | From the first dose of study drug until 30 days after the last dose (12 months) |
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| Secondary | Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 6 and 7 to 12 | 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). | All enrolled and treated participants with available data in each time period | Posted | Mean | Standard Deviation | percentage of expected dose | Cycles 1-6 and 7-12 (each cycle is 28 days) |
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| Secondary | Relative Dose Intensity of Carfilzomib in Cycles 1 to 6 and 7 to 12 | 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). | All enrolled and treated participants with available data in each time period | Posted | Mean | Standard Deviation | percentage of dose intensity | Cycles 1 - 6 and 7 - 12 (each cycle is 28 days) |
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| Secondary | Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6 | 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. | All enrolled and treated participants | Posted | Count of Participants | Participants | Cycles 1 - 6 (each cycle is 28 days) |
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| Secondary | Number of Participants With Carfilzomib Dose Modifications During Cycles 7 to 12 | 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. | Enrolled participants who received treatment during cycles 7 - 12 | Posted | Count of Participants | Participants | Cycles 7 - 12 (each cycle is 28 days) |
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| Secondary | Number of Participants Who Discontinued Carfilzomib in Cycles 1 to 6 and 7 to 12 | Treatment discontinuation for all reasons in cycles 1 - 6 and cycles 7 - 12 | All enrolled and treated participants | Posted | Count of Participants | Participants | Cycles 1 - 6 and 7 - 12 (each cycle is 28 days) |
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| Secondary | 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) | 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. | All enrolled and treated participants | Posted | Mean | Standard Deviation | scores on a scale | Baseline (cycle 1 day 1) to cycle 12 day 1 |
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| Secondary | Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in 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. | Enrolled participants who completed 12 cycles of treatment | Posted | Mean | Standard Deviation | scores on a scale | Baseline (cycle 1 day 1) and cycles 2 - 6 |
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| Secondary | 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 | 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. | Enrolled participants who completed 12 cycles of treatment | Posted | Mean | Standard Deviation | scores on a scale | Cycle 7 day 1 and cycles 8 - 12 |
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| Secondary | Change From Baseline to Last Cycle of Treatment in EORTC QLQ Multiple Myeloma Module (MY-20) Scores | 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. | All enrolled and treated participants | Posted | Mean | Standard Deviation | scores on a scale | Baseline (cycle 1 day 1) and cycle 12 day 1 |
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| Secondary | Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in 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. | Enrolled participants who completed 12 cycles of treatment | Posted | Mean | Standard Deviation | scores on a scale | Baseline (cycle 1 day 1) and cycles 2 - 6 |
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| Secondary | 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 | 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. | Enrolled participants who completed 12 cycles of treatment | Posted | Mean | Standard Deviation | scores on a scale | Cycle 7 day 1 and cycles 8 - 12 |
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| Secondary | Overall Response Rate (ORR) | 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). | All enrolled and treated participants | Posted | Number | 95% Confidence Interval | percentage of participants | Disease assessments were performed every 28 days up to 12 months from enrollment. |
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| Secondary | Overall Response Rate (ORR) After 6 Cycles | 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). | All enrolled and treated participants | Posted | Number | 95% Confidence Interval | percentage of participants | Disease assessments were performed every 28 days up to 6 cycles of treatment (each cycle was 28 days) |
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| Secondary | Overall Response Rate (ORR) by Prior Lines of Therapy | 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). | All enrolled and treated participants | Posted | Number | 95% Confidence Interval | percentage of participants | Disease assessments were performed every 28 days up to 12 months from enrollment. |
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| Secondary | Percentage of Participants With Progression-free Survival (PFS) Events at 12 Months | Progression-free survival events include disease progression or death due to any cause. Disease progression was determined by the Investigator according to IMWG criteria. | All enrolled and treated participants | Posted | Number | percentage of participants | 12 months |
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| Secondary | Percentage of Participants With PFS Events by Prior Lines of Therapy | 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. | All enrolled and treated participants | Posted | Number | percentage of participants | Disease assessments were performed every 28 days up to 12 months from enrollment. |
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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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carfilzomib 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. | 1 | 7 | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Supraventricular extrasystoles | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Dizziness exertional | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
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Because of the limited sample size, no meaningful conclusions on the study objectives can be made.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2018 | Dec 14, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C524865 | carfilzomib |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| ≥ 75 years |
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| Unknown or Not Reported |
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| 2 (Ambulatory but unable to work) |
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| 3 prior regimens |
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