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A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (ARROW2)

Primary Purpose

Relapsed or Refractory Multiple Myeloma

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

About this trial

This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma focused on measuring Bone Marrow Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Multiple myeloma with documented relapse or progression after most recent myeloma treatment. Subjects refractory to the most recent line of therapy are eligible, unless last treatment contained proteasome inhibitor (PI) or lenalidomide and dexamethasone. Refractory is defined as disease that is nonresponsive or progresses within 60 days of last therapy.

Subjects must have at least 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 multiple myeloma (induction therapy followed by stem cell transplant and consolidation maintenance therapy will be considered as 1 line of therapy).

Prior therapy with a PI or the combination of lenalidomide and dexamethasone are allowed if the patient had at least a PR to the most recent treatment with a PI or lenalidomide and dexamethasone, neither PI or lenalidomide and dexamethasone containing treatment were ceased due to toxicity, the patient has not relapsed within 60 days of discontinuation of the PI or lenalidomide and dexamethasone containing treatment. A history of prior neuropathy is permitted if this was not grade 3, grade 4 or grade 2 with pain and if not resolved within the 14 days before enrollment, is less than or equal to grade 2 without pain. Patients are permitted to have received single agent lenalidomide as maintenance therapy within 60 days of enrollment.

Previous treatment with a lenalidomide and dexamethasone containing regimen is allowed, as long as the subject did not progress during the first 3 months after initiating lenalidomide and dexamethasone containing therapy.

Measurable disease with at least 1 of the following assessed within 21 days prior to randomization:

  • Immunoglobulin G (IgG) multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL
  • Immunoglobulin A (IgA), Immunoglobulin D (IgD), Immunoglobulin E (IgE) multiple myeloma: serum M-protein level ≥ 0.5 g/dL
  • Urine M-protein ≥ 200 mg per 24 hours
  • In subjects without measurable 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 ≤ 2

Other inclusion criteria may apply

Exclusion Criteria:

Waldenström macroglobulinemia.

Multiple myeloma of Immunoglobulin M (IgM) subtype.

Plasma cell leukemia (> 2.0 × 10^9 /L circulating plasma cells by standard differential).

Uncontrolled hypertension, defined as a subject whose blood pressure is greater than or equal to 160 mmHg systolic or greater than or equal to 100 mmHg diastolic when taken in accordance with the European Society of Hypertension/European Society of Cardiology 2018 guidelines (Section 12.10; Williams et al, 2018).

Active congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization.

Calculated or measured creatinine clearance < 30 mL/min (calculation must be based on the Cockcroft and Gault formula) within 28 days prior to randomization.

Other exclusion criteria may apply

Sites / Locations

  • Robert A Moss Oncology
  • Rocky Mountain Cancer Centers Denver Midtown
  • Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
  • Baptist MD Anderson Cancer Center
  • Advocate Lutheran General Hospital
  • New York Oncology Hematology, PC
  • Oncology Hematology Care Inc
  • Texas Oncology-Denton
  • US Oncology Research Investigational Products Center
  • Oncology Consultants PA
  • Texas Oncology
  • United States Oncology Regulatory Affairs Corporate Office
  • Universitaetsklinikum Salzburg
  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
  • Specialized Hospital for Active Treatment of Hematology Diseases EAD
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • Fakultni nemocnice Olomouc
  • Vseobecna fakultni nemocnice v Praze
  • Helsingin Yliopistollinen Keskussairaala
  • Oulun Yliopistollinen Sairaala
  • Turun Yliopistollinen Keskussairaala
  • Centre Hospitalier Universitaire de Nantes
  • Centre Hospitalier Universitaire Archet 2
  • Hopital Saint Louis
  • Hopital Pitie-Salpetriere
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
  • Centre Hospitalier Universitaire de Rennes
  • Institut de Cancerologie Strasbourg
  • Institut Universitaire du Cancer Toulouse Oncopole
  • Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
  • Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin
  • Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
  • Universitatsklinikum Hamburg-Eppendorf
  • Universitatsklinikum Koln
  • Johannes Gutenberg Universitaet Mainz
  • University Hospital of Alexandroupolis
  • General Hospital Evangelismos
  • Agios Savvas Anticancer Hospital
  • 251 General Airforce Hospital
  • Alexandra Hospital
  • Metropolitan Hospital
  • General University Hospital of Patras Panagia i Voithia
  • Theagenion Cancer Hospital of Thessaloniki
  • General Hospital of Thessaloniki Georgios Papanikolaou
  • Nagoya City University Hospital
  • Toyohashi Municipal Hospital
  • Tesshokai Kameda General Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Ogaki Municipal Hospital
  • National Hospital Organization Shibukawa Medical Center
  • Japanese Red Cross Society Himeji Hospital
  • Hyogo College of Medicine Hospital
  • Hitachi Ltd Hitachi General Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • National Hospital Organization Sendai Medical Center
  • Niigata Cancer Center Hospital
  • National Hospital Organization Okayama Medical Center
  • Japanese Red Cross Osaka Hospital
  • Kindai University Hospital
  • Osaka University Hospital
  • Saitama Medical Center
  • Tochigi Cancer Center
  • Juntendo University Hospital
  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Japanese Red Cross Medical Center
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
  • Vilnius University Hospital Santaros Clinic Public Institution
  • VU Medisch Centrum
  • Gelre Ziekenhuizen
  • Spaarne Gasthuis
  • Fundeni Clinical Institute
  • Institutul Clinic Fundeni
  • Spitalul Clinic Coltea
  • Spitalul Universitar de Urgenta Bucuresti
  • Spitalul Clinic Colentina
  • Institutul Oncologic Prof Dr Ion Chiricuta
  • Institutul Regional de Oncologie Iasi
  • Spitalul Clinic Dr Gavril Curteanu Oradea
  • Spitalul Clinic Judetean de Urgenta Sibiu
  • Spitalul Clinic Municipal de Urgenta Timisoara
  • Regional Clinical Hospital
  • Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department
  • SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department
  • SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov
  • Federal centre of heart, blood and endocrinology Almazova
  • State Budget Educational Institution of High Professional Skills Samara State Medical University
  • Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda
  • Hospital Universitari Son Espases
  • Hospital Clinico Universitario de Salamanca
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Universitario Quironsalud Madrid
  • Clinica Universidad de Navarra
  • Falu Lasarett
  • Sahlgrenska Universitetssjukhuset
  • Hallands Sjukhus Halmstad
  • Sunderby Sjukhus
  • Skanes Universitetssjukhus
  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
  • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
  • Istanbul Universitesi Istanbul Tip Fakultesi
  • Bagcilar Medipol Mega Universite Hastanesi
  • Istanbul Florence Nightingale Hastanesi
  • Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi
  • Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Carfilzomib once-weekly

Carfilzomib twice-weekly

Arm Description

Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using once-weekly carfilzomib 56 mg/m2

Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using twice-weekly carfilzomib 27 mg/m2

Outcomes

Primary Outcome Measures

Overall Response (OR)
Defined as the best overall response of stringent complete response [sCR], complete response [CR], very good partial response [VGPR] and partial response [PR] per International Myeloma Working Group Uniform Response Criteria [IMWG-URC]

Secondary Outcome Measures

Progression free survival (PFS)
Convenience
As measured by the Patient-reported convenience with carfilzomib dosing schedule question
Subject incidence of treatment-emergent adverse events
Additional efficacy parameter - Time to Response
As measured by Time to Response (TTR)
Additional efficacy parameter - Duration of Response
Duration of Response (DOR)
Additional efficacy parameter - Time to Progression
Time to Progression (TTP)
Overall Survival
MRD[-]CR rate
Defined as achievement of CR or better by Independent Review Committee (IRC) per IMWG-URC and achievement of Minimal Residual Disease (MRD) negativity as assessed by next-generation sequencing method at a 10^ -5 threshold
MRD[-] status at 12 months
Defined as achievement of Minimal Residual Disease (MRD) negativity at 12 months (+/- 4 weeks) from randomisation as assessed by next-generation sequencing method at a 10^ -5 threshold
Physical functioning and role functioning
As measured by the Physical Functioning and Role Functioning scales of the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30), a 30-item generic instrument for use in cancer subjects across tumor types
Treatment satisfaction as measured by the Satisfaction with Therapy (SWT) subscale of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Cancer Therapy Satisfaction Questionnaire (CTSQ) - measures treatment satisfaction in individuals with cancer

Full Information

First Posted
January 14, 2019
Last Updated
April 3, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03859427
Brief Title
A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Acronym
ARROW2
Official Title
A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma
Keywords
Bone Marrow Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Carfilzomib once-weekly
Arm Type
Active Comparator
Arm Description
Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using once-weekly carfilzomib 56 mg/m2
Arm Title
Carfilzomib twice-weekly
Arm Type
Active Comparator
Arm Description
Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using twice-weekly carfilzomib 27 mg/m2
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
Once weekly IV over 30 minutes on day 1, 8 and 15 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 day 1 and 56 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
Twice weekly IV over 10 minutes on day 1, 2, 8, 9, 15 and 16 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 days 1 and 2 and 27 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Once daily orally 25 mg days 1 to 21 of each cycle. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Once daily orally or by IV 40 mg days 1, 8 and 15 of each cycle. Also day 22 of cycles 1 to 9. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent
Primary Outcome Measure Information:
Title
Overall Response (OR)
Description
Defined as the best overall response of stringent complete response [sCR], complete response [CR], very good partial response [VGPR] and partial response [PR] per International Myeloma Working Group Uniform Response Criteria [IMWG-URC]
Time Frame
Through study completion, an average of 14 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
Through study completion, an average of 14 months
Title
Convenience
Description
As measured by the Patient-reported convenience with carfilzomib dosing schedule question
Time Frame
Through study completion, an average of 14 months
Title
Subject incidence of treatment-emergent adverse events
Time Frame
Through study completion, an average of 14 months
Title
Additional efficacy parameter - Time to Response
Description
As measured by Time to Response (TTR)
Time Frame
Through study completion, an average of 14 months
Title
Additional efficacy parameter - Duration of Response
Description
Duration of Response (DOR)
Time Frame
Through study completion, an average of 14 months
Title
Additional efficacy parameter - Time to Progression
Description
Time to Progression (TTP)
Time Frame
Through study completion, an average of 14 months
Title
Overall Survival
Time Frame
Through study completion, an average of 14 months
Title
MRD[-]CR rate
Description
Defined as achievement of CR or better by Independent Review Committee (IRC) per IMWG-URC and achievement of Minimal Residual Disease (MRD) negativity as assessed by next-generation sequencing method at a 10^ -5 threshold
Time Frame
Through study completion, an average of 14 months
Title
MRD[-] status at 12 months
Description
Defined as achievement of Minimal Residual Disease (MRD) negativity at 12 months (+/- 4 weeks) from randomisation as assessed by next-generation sequencing method at a 10^ -5 threshold
Time Frame
12 months
Title
Physical functioning and role functioning
Description
As measured by the Physical Functioning and Role Functioning scales of the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30), a 30-item generic instrument for use in cancer subjects across tumor types
Time Frame
Through study completion, an average of 14 months
Title
Treatment satisfaction as measured by the Satisfaction with Therapy (SWT) subscale of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Description
Cancer Therapy Satisfaction Questionnaire (CTSQ) - measures treatment satisfaction in individuals with cancer
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Multiple myeloma with documented relapse or progression after most recent myeloma treatment. Subjects refractory to the most recent line of therapy are eligible, unless last treatment contained proteasome inhibitor (PI) or lenalidomide and dexamethasone. Refractory is defined as disease that is nonresponsive or progresses within 60 days of last therapy. Subjects must have at least 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 multiple myeloma (induction therapy followed by stem cell transplant and consolidation maintenance therapy will be considered as 1 line of therapy). Prior therapy with a PI or the combination of lenalidomide and dexamethasone are allowed if the patient had at least a PR to the most recent treatment with a PI or lenalidomide and dexamethasone, neither PI or lenalidomide and dexamethasone containing treatment were ceased due to toxicity, the patient has not relapsed within 60 days of discontinuation of the PI or lenalidomide and dexamethasone containing treatment. A history of prior neuropathy is permitted if this was not grade 3, grade 4 or grade 2 with pain and if not resolved within the 14 days before enrollment, is less than or equal to grade 2 without pain. Patients are permitted to have received single agent lenalidomide as maintenance therapy within 60 days of enrollment. Previous treatment with a lenalidomide and dexamethasone containing regimen is allowed, as long as the subject did not progress during the first 3 months after initiating lenalidomide and dexamethasone containing therapy. Measurable disease with at least 1 of the following assessed within 21 days prior to randomization: Immunoglobulin G (IgG) multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL Immunoglobulin A (IgA), Immunoglobulin D (IgD), Immunoglobulin E (IgE) multiple myeloma: serum M-protein level ≥ 0.5 g/dL Urine M-protein ≥ 200 mg per 24 hours In subjects without measurable 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 ≤ 2 Other inclusion criteria may apply Exclusion Criteria: Waldenström macroglobulinemia. Multiple myeloma of Immunoglobulin M (IgM) subtype. Plasma cell leukemia (> 2.0 × 10^9 /L circulating plasma cells by standard differential). Uncontrolled hypertension, defined as a subject whose blood pressure is greater than or equal to 160 mmHg systolic or greater than or equal to 100 mmHg diastolic when taken in accordance with the European Society of Hypertension/European Society of Cardiology 2018 guidelines (Section 12.10; Williams et al, 2018). Active congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization. Calculated or measured creatinine clearance < 30 mL/min (calculation must be based on the Cockcroft and Gault formula) within 28 days prior to randomization. Other exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Robert A Moss Oncology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Rocky Mountain Cancer Centers Denver Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
City
Plainville
State/Province
Connecticut
ZIP/Postal Code
06062
Country
United States
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Oncology Hematology Care Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Texas Oncology-Denton
City
Denton
State/Province
Texas
ZIP/Postal Code
76201
Country
United States
Facility Name
US Oncology Research Investigational Products Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Oncology Consultants PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
United States Oncology Regulatory Affairs Corporate Office
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Universitaetsklinikum Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Hematology Diseases EAD
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Helsingin Yliopistollinen Keskussairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Oulun Yliopistollinen Sairaala
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Turun Yliopistollinen Keskussairaala
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Hospitalier Universitaire Archet 2
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Institut de Cancerologie Strasbourg
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Facility Name
Institut Universitaire du Cancer Toulouse Oncopole
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
City
Vandoeuvre les Nancy Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitatsklinikum Koln
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Johannes Gutenberg Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University Hospital of Alexandroupolis
City
Alexandroupoli
ZIP/Postal Code
68100
Country
Greece
Facility Name
General Hospital Evangelismos
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Agios Savvas Anticancer Hospital
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
251 General Airforce Hospital
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Metropolitan Hospital
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
General University Hospital of Patras Panagia i Voithia
City
Patra
ZIP/Postal Code
26504
Country
Greece
Facility Name
Theagenion Cancer Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Facility Name
General Hospital of Thessaloniki Georgios Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Nagoya City University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Toyohashi Municipal Hospital
City
Toyohashi-shi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Tesshokai Kameda General Hospital
City
Kamogawa-shi
State/Province
Chiba
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
National Hospital Organization Shibukawa Medical Center
City
Shibukawa-shi
State/Province
Gunma
ZIP/Postal Code
377-0280
Country
Japan
Facility Name
Japanese Red Cross Society Himeji Hospital
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
670-8540
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Hitachi Ltd Hitachi General Hospital
City
Hitachi-shi
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Japanese Red Cross Osaka Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya-shi
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Clinic Public Institution
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Gelre Ziekenhuizen
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Spaarne Gasthuis
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Coltea
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Institutul Oncologic Prof Dr Ion Chiricuta
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Spitalul Clinic Dr Gavril Curteanu Oradea
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sibiu
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Spitalul Clinic Municipal de Urgenta Timisoara
City
Timisoara
ZIP/Postal Code
300079
Country
Romania
Facility Name
Regional Clinical Hospital
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Federal centre of heart, blood and endocrinology Almazova
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
State Budget Educational Institution of High Professional Skills Samara State Medical University
City
Samara
ZIP/Postal Code
443079
Country
Russian Federation
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
State/Province
Castilla León
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Hallands Sjukhus Halmstad
City
Halmstad
ZIP/Postal Code
301 85
Country
Sweden
Facility Name
Sunderby Sjukhus
City
Lulea
ZIP/Postal Code
971 80
Country
Sweden
Facility Name
Skanes Universitetssjukhus
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Bagcilar Medipol Mega Universite Hastanesi
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Istanbul Florence Nightingale Hastanesi
City
Istanbul
ZIP/Postal Code
34387
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
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 (or other new use) 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.
IPD Sharing Access Criteria
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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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