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Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma (ARROW)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Carfilzomib
Dexamethasone
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Relapsed multiple myeloma
  2. Refractory multiple myeloma defined as meeting 1 or more of the following:

    • Nonresponsive to most recent therapy (stable disease only or PD while on treatment), or
    • Disease progression within 60 days of discontinuation from most recent therapy
  3. At least 2 but no more than 3 prior therapies for multiple myeloma
  4. Prior exposure to an immunomodulatory agent (IMiD)
  5. Prior exposure to a proteasome inhibitor (PI)
  6. Documented response of at least partial response (PR) to 1 line of prior therapy
  7. Measurable disease with at least 1 of the following assessed within the 21 days prior to randomization:

    • Serum M-protein ≥ 0.5 g/dL
    • Urine M-protein ≥ 200 mg/24 hours
    • In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
  8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  9. Left ventricular ejection fraction (LVEF) ≥ 40% within the 21 days prior to randomization
  10. Adequate organ and bone marrow function within the 21 days prior to randomization defined by:

    • Bilirubin < 1.5 times the upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN
    • Absolute neutrophil count (ANC) ≥ 1000/mm³ (screening ANC should be independent of growth factor support for ≥ 1 week)
    • Hemoglobin ≥ 8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.)
    • Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is > 50%. Subjects should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.)
    • Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/min

Key Exclusion Criteria:

  1. Waldenström macroglobulinemia
  2. Multiple myeloma of Immunoglobin M (IgM) subtype
  3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  4. Plasma cell leukemia (> 2.0 × 10⁹/L circulating plasma cells by standard differential)
  5. Myelodysplastic syndrome
  6. Second malignancy within the past 5 years except:

    • Adequately treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
    • Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins)
    • Treated medullary or papillary thyroid cancer
    • Similar condition with an expectation of > 95% five-year disease-free survival
  7. History of or current amyloidosis
  8. Cytotoxic chemotherapy within the 28 days prior to randomization
  9. Immunotherapy within the 21 days prior to randomization
  10. Glucocorticoid therapy within the 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or 1000 mg prednisone
  11. Radiation therapy:

    • Focal therapy within the 7 days prior to randomization
    • Extended field therapy within the 21 days prior to randomization
  12. Prior treatment with either carfilzomib or oprozomib
  13. Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
  14. Contraindication to dexamethasone or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment
  15. Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 6 months prior to enrollment
  16. Active infection within the 14 days prior to randomization requiring systemic antibiotics
  17. Pleural effusions requiring thoracentesis within the 14 days prior to randomization
  18. Ascites requiring paracentesis within the 14 days prior to randomization
  19. Ongoing graft-versus-host disease
  20. Uncontrolled hypertension or uncontrolled diabetes despite medication
  21. Significant neuropathy (≥ Grade 3) within the 14 days prior to randomization
  22. Known cirrhosis

Sites / Locations

  • Research Site
  • Mayo Clinic
  • Research Site
  • Center for Cancer and Blood Disorders
  • Research Site
  • Maryland Oncology Hematology, P.A
  • Research Site
  • John Theurer Cancer Center at Hackensack University Medical Center
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  • Blood and Cancer Center of East Texas
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone

Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone

Arm Description

Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.

Participants received carfilzomib administered by IV infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.

Outcomes

Primary Outcome Measures

Progression Free Survival
Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease status was assessed at a central laboratory with serum and urine protein electrophoresis, immunofixation, serum-free light chain (SFLC) assay, bone marrow sample evaluation, serum calcium, plasmacytoma evaluation, and skeletal survey. Response and disease progression were determined using a validated computer algorithm based on the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Median PFS was derived using the Kaplan-Meier method; participants still alive with no disease progression were censored at the time of their last disease assessment.

Secondary Outcome Measures

Overall Response Rate
Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response rate 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.
Overall Survival
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Median overall survival was derived using the Kaplan-Meier method; participants still alive were censored at the date last known to be alive.
Number of Participants With Adverse Events (AEs)
The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal. Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship.
Plasma Carfilzomib Concentration During Cycle 2
Concentrations of carfilzomib in plasma were measured using a validated assay method. The lower limit of quantification was 0.100 ng/mL.

Full Information

First Posted
April 6, 2015
Last Updated
September 9, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02412878
Brief Title
Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma
Acronym
ARROW
Official Title
A Randomized, Open-label, Phase 3 Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2015 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
January 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to compare the progression-free survival (PFS) of once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in adults with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
478 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone
Arm Type
Experimental
Arm Description
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Arm Title
Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
Arm Type
Experimental
Arm Description
Participants received carfilzomib administered by IV infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
PR-171, PR171, Kyprolis® (carfilzomib) for Injection
Intervention Description
Carfilzomib was administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Commercially available dexamethasone was obtained by the investigational site.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease status was assessed at a central laboratory with serum and urine protein electrophoresis, immunofixation, serum-free light chain (SFLC) assay, bone marrow sample evaluation, serum calcium, plasmacytoma evaluation, and skeletal survey. Response and disease progression were determined using a validated computer algorithm based on the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Median PFS was derived using the Kaplan-Meier method; participants still alive with no disease progression were censored at the time of their last disease assessment.
Time Frame
From randomization until the data cut-off date of 15 June 2017; median (minimum, maximum) follow-up time for PFS was 12.0 (0, 20) and 12.6 (0, 19) months in each treatment group respectively.
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response rate 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.
Time Frame
Disease response was assessed every 28 days until progressive disease, up to the data cut-off date of 15 June 2017; median time on follow-up was 12.0 and 12.6 months in each treatment group respectively.
Title
Overall Survival
Description
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Median overall survival was derived using the Kaplan-Meier method; participants still alive were censored at the date last known to be alive.
Time Frame
From randomization until the data cut-off date of 15 June 2017; median (minimum, maximum) follow-up time for OS was 12.6 (0, 20) and 13.2 (0, 19) months in each treatment group respectively.
Title
Number of Participants With Adverse Events (AEs)
Description
The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal. Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship.
Time Frame
From first dose of study drug up to 30 days after last dose, up to the end of study; median (minimum, maximum) duration of treatment was 29.1 (0.1, 156.3) weeks and 38.0 (0.1, 158.3) weeks in each treatment group respectively.
Title
Plasma Carfilzomib Concentration During Cycle 2
Description
Concentrations of carfilzomib in plasma were measured using a validated assay method. The lower limit of quantification was 0.100 ng/mL.
Time Frame
Cycle 2 day 1 predose, 15 minutes after the start of infusion (once-weekly carfilzomib only), end of infusion, and 30 minutes after the end of infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Relapsed multiple myeloma Refractory multiple myeloma defined as meeting 1 or more of the following: Nonresponsive to most recent therapy (stable disease only or PD while on treatment), or Disease progression within 60 days of discontinuation from most recent therapy At least 2 but no more than 3 prior therapies for multiple myeloma Prior exposure to an immunomodulatory agent (IMiD) Prior exposure to a proteasome inhibitor (PI) Documented response of at least partial response (PR) to 1 line of prior therapy Measurable disease with at least 1 of the following assessed within the 21 days prior to randomization: Serum M-protein ≥ 0.5 g/dL Urine M-protein ≥ 200 mg/24 hours In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 Left ventricular ejection fraction (LVEF) ≥ 40% within the 21 days prior to randomization Adequate organ and bone marrow function within the 21 days prior to randomization defined by: Bilirubin < 1.5 times the upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN Absolute neutrophil count (ANC) ≥ 1000/mm³ (screening ANC should be independent of growth factor support for ≥ 1 week) Hemoglobin ≥ 8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.) Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is > 50%. Subjects should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.) Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/min Key Exclusion Criteria: Waldenström macroglobulinemia Multiple myeloma of Immunoglobin M (IgM) subtype POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) Plasma cell leukemia (> 2.0 × 10⁹/L circulating plasma cells by standard differential) Myelodysplastic syndrome Second malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins) Treated medullary or papillary thyroid cancer Similar condition with an expectation of > 95% five-year disease-free survival History of or current amyloidosis Cytotoxic chemotherapy within the 28 days prior to randomization Immunotherapy within the 21 days prior to randomization Glucocorticoid therapy within the 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or 1000 mg prednisone Radiation therapy: Focal therapy within the 7 days prior to randomization Extended field therapy within the 21 days prior to randomization Prior treatment with either carfilzomib or oprozomib Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib) Contraindication to dexamethasone or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 6 months prior to enrollment Active infection within the 14 days prior to randomization requiring systemic antibiotics Pleural effusions requiring thoracentesis within the 14 days prior to randomization Ascites requiring paracentesis within the 14 days prior to randomization Ongoing graft-versus-host disease Uncontrolled hypertension or uncontrolled diabetes despite medication Significant neuropathy (≥ Grade 3) within the 14 days prior to randomization Known cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Maryland Oncology Hematology, P.A
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Research Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Blood and Cancer Center of East Texas
City
Tyler
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Research Site
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Research Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Research Site
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Research Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Research Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Research Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Research Site
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Research Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Research Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Research Site
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Research Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Research Site
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Research Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Research Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site
City
Nimes cedex 09
ZIP/Postal Code
30029
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Research Site
City
Pierre-Benite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Research Site
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Research Site
City
Tours Cedex 1
ZIP/Postal Code
37044
Country
France
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Research Site
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Research Site
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Research Site
City
Patra
ZIP/Postal Code
26504
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Research Site
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Research Site
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
Research Site
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Toyohashi-shi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Research Site
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Research Site
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Research Site
City
Shibukawa-shi
State/Province
Gunma
ZIP/Postal Code
377-8511
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Research Site
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Research Site
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Research Site
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Research Site
City
Utsunomiya-shi
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Research Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Research Site
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Research Site
City
Tachikawa-shi
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Research Site
City
Tokushima-shi
ZIP/Postal Code
770-8539
Country
Japan
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Otahuhu, Auckland
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
Research Site
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Research Site
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Research Site
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Research Site
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-032
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Research Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Research Site
City
Brazov
ZIP/Postal Code
500152
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Research Site
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50012
Country
Spain
Facility Name
Research Site
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Research Site
City
Salamanca
State/Province
Castilla León
ZIP/Postal Code
37007
Country
Spain
Facility Name
Research Site
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Girona
State/Province
Cataluña
ZIP/Postal Code
17007
Country
Spain
Facility Name
Research Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Research Site
City
Helsingborg
ZIP/Postal Code
251 87
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Research Site
City
Uddevalla
ZIP/Postal Code
451 80
Country
Sweden
Facility Name
Research Site
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Research Site
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29866475
Citation
Moreau P, Mateos MV, Berenson JR, Weisel K, Lazzaro A, Song K, Dimopoulos MA, Huang M, Zahlten-Kumeli A, Stewart AK. Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. Lancet Oncol. 2018 Jul;19(7):953-964. doi: 10.1016/S1470-2045(18)30354-1. Epub 2018 Jun 1. Erratum In: Lancet Oncol. 2018 Aug;19(8):e382.
Results Reference
background
PubMed Identifier
33166401
Citation
Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.
Results Reference
background
PubMed Identifier
32152297
Citation
Dimopoulos MA, Niesvizky R, Weisel K, Siegel DS, Hajek R, Mateos MV, Cavo M, Huang M, Zahlten-Kumeli A, Moreau P. Once- versus twice-weekly carfilzomib in relapsed and refractory multiple myeloma by select patient characteristics: phase 3 A.R.R.O.W. study subgroup analysis. Blood Cancer J. 2020 Mar 9;10(3):35. doi: 10.1038/s41408-020-0300-y.
Results Reference
background
PubMed Identifier
32108443
Citation
Moreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28.
Results Reference
background
PubMed Identifier
31092895
Citation
Moreau P, Kumar S, Boccia R, Iida S, Goldschmidt H, Cocks K, Trigg A, Zahlten-Kumeli A, Yucel E, Panjabi SS, Dimopoulos M. Convenience, satisfaction, health-related quality of life of once-weekly 70 mg/m2 vs. twice-weekly 27 mg/m2 carfilzomib (randomized A.R.R.O.W. study). Leukemia. 2019 Dec;33(12):2934-2946. doi: 10.1038/s41375-019-0480-2. Epub 2019 May 15.
Results Reference
background
PubMed Identifier
32249621
Citation
Kumar SK, Majer I, Panjabi S, Medhekar R, Campioni M, Dimopoulos MA. Cost-effectiveness of once weekly carfilzomib 70 mg/m2 plus dexamethasone in patients with relapsed and refractory multiple myeloma in the United States. Expert Rev Hematol. 2020 Jun;13(6):687-696. doi: 10.1080/17474086.2020.1746639. Epub 2020 Apr 6.
Results Reference
background
PubMed Identifier
31388932
Citation
Dimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma

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