Multiple Myeloma Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

454

Study ID:

NCT03859427

Recruitment Status:

Active, not recruiting

Sponsor:

Amgen

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There are 107 Locations for this study

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Robert A Moss Oncology
Fountain Valley California, 92708, United States
Rocky Mountain Cancer Centers Denver Midtown
Denver Colorado, 80218, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
Plainville Connecticut, 06062, United States
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States
Advocate Lutheran General Hospital
Park Ridge Illinois, 60068, United States
New York Oncology Hematology, PC
Albany New York, 12208, United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45242, United States
Texas Oncology-Denton
Denton Texas, 76201, United States
US Oncology Research Investigational Products Center
Fort Worth Texas, 76177, United States
Oncology Consultants PA
Houston Texas, 77030, United States
Texas Oncology
San Antonio Texas, 78229, United States
United States Oncology Regulatory Affairs Corporate Office
The Woodlands Texas, 77380, United States
Universitaetsklinikum Salzburg
Salzburg , 5020, Austria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv , 4002, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia , 1431, Bulgaria
Specialized Hospital for Active Treatment of Hematology Diseases EAD
Sofia , 1756, Bulgaria
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Olomouc
Olomouc , 775 2, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Helsingin Yliopistollinen Keskussairaala
Helsinki , 00290, Finland
Oulun Yliopistollinen Sairaala
Oulu , 90220, Finland
Turun Yliopistollinen Keskussairaala
Turku , 20521, Finland
Centre Hospitalier Universitaire de Nantes
Nantes , 44000, France
Centre Hospitalier Universitaire Archet 2
Nice cedex 3 , 06202, France
Hopital Saint Louis
Paris , 75010, France
Hopital Pitie-Salpetriere
Paris , 75013, France
Centre Hospitalier Lyon Sud
Pierre-Benite , 69495, France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers Cedex , 86021, France
Centre Hospitalier Universitaire de Rennes
Rennes , 35033, France
Institut de Cancerologie Strasbourg
Strasbourg , 67033, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse cedex 9 , 31059, France
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
Vandoeuvre les Nancy Cedex , 54511, France
Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin
Berlin , 12200, Germany
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
Dresden , 01307, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg , 20246, Germany
Universitatsklinikum Koln
Köln , 50924, Germany
Johannes Gutenberg Universitaet Mainz
Mainz , 55131, Germany
University Hospital of Alexandroupolis
Alexandroupoli , 68100, Greece
General Hospital Evangelismos
Athens , 10676, Greece
Agios Savvas Anticancer Hospital
Athens , 115 2, Greece
251 General Airforce Hospital
Athens , 11525, Greece
Alexandra Hospital
Athens , 11528, Greece
Metropolitan Hospital
Athens , 18547, Greece
General University Hospital of Patras Panagia i Voithia
Patra , 26504, Greece
Theagenion Cancer Hospital of Thessaloniki
Thessaloniki , 54007, Greece
General Hospital of Thessaloniki Georgios Papanikolaou
Thessaloniki , 57010, Greece
Nagoya City University Hospital
Nagoya-shi Aichi, 467-8, Japan
Toyohashi Municipal Hospital
Toyohashi-shi Aichi, 441-8, Japan
Tesshokai Kameda General Hospital
Kamogawa-shi Chiba, 296-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi Fukuoka, 811-1, Japan
Ogaki Municipal Hospital
Ogaki-shi Gifu, 503-8, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa-shi Gunma, 377-0, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-shi Hyogo, 670-8, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi Hyogo, 663-8, Japan
Hitachi Ltd Hitachi General Hospital
Hitachi-shi Ibaraki, 317-0, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto-shi Kyoto, 602-8, Japan
National Hospital Organization Sendai Medical Center
Sendai-shi Miyagi, 983-8, Japan
Niigata Cancer Center Hospital
Niigata-shi Niigata, 951-8, Japan
National Hospital Organization Okayama Medical Center
Okayama-shi Okayama, 701-1, Japan
Japanese Red Cross Osaka Hospital
Osaka-shi Osaka, 543-8, Japan
Kindai University Hospital
Osakasayama-shi Osaka, 589-8, Japan
Osaka University Hospital
Suita-shi Osaka, 565-0, Japan
Saitama Medical Center
Kawagoe-shi Saitama, 350-8, Japan
Tochigi Cancer Center
Utsunomiya-shi Tochigi, 320-0, Japan
Juntendo University Hospital
Bunkyo-ku Tokyo, 113-8, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Tokyo, 135-8, Japan
Japanese Red Cross Medical Center
Shibuya-ku Tokyo, 150-8, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
Kaunas , 50009, Lithuania
Vilnius University Hospital Santaros Clinic Public Institution
Vilnius , 08661, Lithuania
VU Medisch Centrum
Amsterdam , 1081 , Netherlands
Gelre Ziekenhuizen
Apeldoorn , 7334 , Netherlands
Spaarne Gasthuis
Hoofddorp , 2134 , Netherlands
Fundeni Clinical Institute
Bucharest , 02232, Romania
Institutul Clinic Fundeni
Bucharest , 02232, Romania
Spitalul Clinic Coltea
Bucharest , 03017, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest , 05009, Romania
Spitalul Clinic Colentina
Bucuresti , 02012, Romania
Institutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca , 40001, Romania
Institutul Regional de Oncologie Iasi
Iasi , 70048, Romania
Spitalul Clinic Dr Gavril Curteanu Oradea
Oradea , 41046, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu , 55024, Romania
Spitalul Clinic Municipal de Urgenta Timisoara
Timisoara , 30007, Romania
Regional Clinical Hospital
Krasnoyarsk , 66002, Russian Federation
Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department
Moscow , 12318, Russian Federation
SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department
Moscow , 12528, Russian Federation
SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov
Petrozavodsk , 18501, Russian Federation
Federal centre of heart, blood and endocrinology Almazova
Saint Petersburg , 19734, Russian Federation
State Budget Educational Institution of High Professional Skills Samara State Medical University
Samara , 44307, Russian Federation
Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda
Bratislava , 851 0, Slovakia
Hospital Universitari Son Espases
Palma de Mallorca Baleares, 07010, Spain
Hospital Clinico Universitario de Salamanca
Salamanca Castilla León, 37007, Spain
Hospital Universitari Germans Trias i Pujol
Badalona Cataluña, 08916, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona Cataluña, 08036, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon Madrid, 28223, Spain
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Falu Lasarett
Falun , 791 8, Sweden
Sahlgrenska Universitetssjukhuset
Goteborg , 413 4, Sweden
Hallands Sjukhus Halmstad
Halmstad , 301 8, Sweden
Sunderby Sjukhus
Lulea , 971 8, Sweden
Skanes Universitetssjukhus
Lund , 221 8, Sweden
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara , 06560, Turkey
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara , 06590, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul , 34093, Turkey
Bagcilar Medipol Mega Universite Hastanesi
Istanbul , 34214, Turkey
Istanbul Florence Nightingale Hastanesi
Istanbul , 34387, Turkey
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi
Izmir , 35340, Turkey
Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi
Kayseri , 38039, Turkey

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

454

Study ID:

NCT03859427

Recruitment Status:

Active, not recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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