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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01818752
Registration number
NCT01818752
Ethics application status
Date submitted
12/02/2013
Date registered
26/03/2013
Date last updated
26/08/2019
Titles & IDs
Public title
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
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Scientific title
A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
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Secondary ID [1]
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2012-005283-97
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Secondary ID [2]
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2012-005
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Universal Trial Number (UTN)
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Trial acronym
CLARION
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Bortezomib
Treatment: Drugs - Melphalan
Treatment: Drugs - Prednisone
Experimental: Carfilzomib, Melphalan, Prednisone - Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Active Comparator: Bortezomib, Melphalan, Prednisone - Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Treatment: Drugs: Carfilzomib
Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1.
Treatment: Drugs: Bortezomib
Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9.
Treatment: Drugs: Melphalan
Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.
Treatment: Drugs: Prednisone
Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression.
Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner.
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Timepoint [1]
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From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall survival (OS) was defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored on the date the patient was last known to be alive.
Median overall survival was estimated using the Kaplan-Meier method.
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Timepoint [1]
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From randomization until the data cut-off date of 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively.
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Secondary outcome [2]
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Overall Response Rate
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Assessment method [2]
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Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).
CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or = 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A = 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
PR: = 50% reduction of serum M-protein and reduction in urine M-protein by = 90% or to < 200 mg/24 hours. A = 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
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Timepoint [2]
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Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
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Secondary outcome [3]
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Complete Response Rate
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Assessment method [3]
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Complete response rate was defined as the percentage of participants in each treatment group who achieved a sCR or CR per the IMWG-URC as their best response.
sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).
CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy.
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Timepoint [3]
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Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
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Secondary outcome [4]
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Percentage of Participants With = Grade 2 Peripheral Neuropathy
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Assessment method [4]
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Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.
Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:
Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death.
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Timepoint [4]
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From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
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Secondary outcome [5]
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European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores
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Assessment method [5]
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The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items 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, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL.
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Timepoint [5]
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Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48
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Secondary outcome [6]
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Number of Participants With Adverse Events
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Assessment method [6]
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Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal.
A serious adverse event is an adverse event that met 1 or more of the following criteria:
Death
Life-threatening
Required inpatient hospitalization or prolongation of an existing hospitalization
Resulted in persistent or significant disability/incapacity
Congenital anomaly/birth defect
Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above.
Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship.
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Timepoint [6]
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From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
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Eligibility
Key inclusion criteria
1. Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group
[IMWG] diagnostic criteria)
2. Transplant ineligibility
3. Measurable disease, as defined by 1 or more of the following (assessed within 21 days
prior to randomization):
- Serum M-protein = 0.5 g/dL, or
- Urine M-protein = 200 mg/24 hours, or
- In subjects without detectable serum or urine M-protein, serum free light chain
(SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC
kappa lambda ratio < 0.26 or > 1.65)
4. No prior treatment for multiple myeloma
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Multiple myeloma of IgM (immunoglobulin M) subtype
2. Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a
cumulative dose of 160 mg of dexamethasone
3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes)
4. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard
differential)
5. Waldenström macroglobulinemia (WM)
6. Known amyloidosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/11/2016
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Sample size
Target
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Accrual to date
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Final
955
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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St. Vincent's Hospital Sydney - Darlinghurst
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Central Coast Local Health District - North Gosford
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Calvary Mater Newcastle - Waratah
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Royal Adelaide Hospital - Adelaide
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Eastern Health - Box Hill Hospital - Box Hill
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St. Vincent's Hospital Melbourne - Fitzroy
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The Alfred Hospital - Melbourne
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Border Medical Oncology - Wodonga
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Recruitment hospital [10]
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Royal North Shore Hospital, Haematology Department - New South Wales
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Recruitment postcode(s) [1]
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2050 - Camperdown
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2010 - Darlinghurst
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2250 - North Gosford
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Recruitment postcode(s) [4]
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2298 - Waratah
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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- Fitzroy
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3004 - Melbourne
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Recruitment postcode(s) [9]
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3690 - Wodonga
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Recruitment postcode(s) [10]
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- New South Wales
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Recruitment outside Australia
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California
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Pierre Bénite, Cedex
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GE
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TO
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Rome
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Torino
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Fukuoka-Ken
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Fukuoka
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Gifu
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Gunma
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Hokkaidou
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Okayama
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Osaka
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Tochigi
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Japan
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Tokyo
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Japan
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Kyoto
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Japan
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Tokushima
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Korea, Republic of
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Gyeonggi-do
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Jeollanam-do
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Seoul
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Mexico
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Nuevo Leon
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Mexico
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Mendoza
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Mexico
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Mexico
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Puebla
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Wellington
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Poland
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OIsztyn
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Torun
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Poland
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Warsaw
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Romania
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Cluj County
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Romania
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Russian Federation
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Russian Federation
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Arkhangelsk
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Russian Federation
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Izhevsk
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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St. Petersburg
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Singapore
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Lausanne
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Switzerland
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Saint Gallen
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Taiwan
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Taiwan
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Taichung
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Taipei
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Taiwan
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Tapei
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Turkey
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Bornova
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Turkey
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Cebeci
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Turkey
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Pendik
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Ukraine
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Cherkasy
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Khmelnytskyi
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Poltava
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Ukraine
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Uzhgorod
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Ukraine
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Vinnitsya
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Ukraine
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Zhytomyr
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United Kingdom
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Kent
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United Kingdom
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Middlesex
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United Kingdom
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Inverness
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United Kingdom
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London
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United Kingdom
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Oxford
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Ethics approval
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Summary
Brief summary
The primary objective was to compare the progression-free survival of transplant ineligible
patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan
and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01818752
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Trial related presentations / publications
Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.
Facon T, Lee JH, Moreau P, Niesvizky R, Dimopoulos M, Hajek R, Pour L, Jurczyszyn A, Qiu L, Klippel Z, Zahlten-Kumeli A, Osman M, Paiva B, San-Miguel J. Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2019 May 2;133(18):1953-1963. doi: 10.1182/blood-2018-09-874396. Epub 2019 Feb 28.
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Public notes
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Contacts
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MD
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Amgen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01818752
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