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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 99 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03859427 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Amgen |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
MD |
Principal Investigator Affiliation | Amgen |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Austria, Bulgaria, Czechia, Finland, France, Germany, Greece, Japan, Lithuania, Netherlands, Romania, Russian Federation, Slovakia, Spain, Sweden, Turkey, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Relapsed or Refractory Multiple Myeloma |
Study Website: | View Trial Website |
Active Comparator: Carfilzomib once-weekly
Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using once-weekly carfilzomib 56 mg/m2
Active Comparator: Carfilzomib twice-weekly
Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using twice-weekly carfilzomib 27 mg/m2
Drug: - Carfilzomib
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.
Drug: - Carfilzomib
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.
Drug: - Lenalidomide
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
Drug: - Dexamethasone
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Terminated
Address
Robert A Moss Oncology
Fountain Valley, California, 92708
Status
Terminated
Address
Rocky Mountain Cancer Centers Denver Midtown
Denver, Colorado, 80218
Status
Terminated
Address
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
Plainville, Connecticut, 06062
Status
Terminated
Address
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Status
Terminated
Address
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Status
Terminated
Address
New York Oncology Hematology, PC
Albany, New York, 12208
Status
Recruiting
Address
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
Status
Terminated
Address
Texas Oncology-Denton
Denton, Texas, 76201
Status
Recruiting
Address
US Oncology Research Investigational Products Center
Fort Worth, Texas, 76177
Status
Terminated
Address
Oncology Consultants PA
Houston, Texas, 77030
Status
Recruiting
Address
Texas Oncology
San Antonio, Texas, 78229
Status
Recruiting
Address
United States Oncology Regulatory Affairs Corporate Office
The Woodlands, Texas, 77380
Status
Recruiting
Address
Universitaetsklinikum Salzburg
Salzburg, , 5020
Status
Recruiting
Address
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, , 4002
Status
Recruiting
Address
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia, , 1431
Status
Recruiting
Address
Specialized Hospital for Active Treatment of Hematology Diseases EAD
Sofia, , 1756
Status
Recruiting
Address
Fakultni nemocnice Brno
Brno, , 625 00
Status
Recruiting
Address
Fakultni nemocnice Hradec Kralove
Hradec Kralove, , 500 05
Status
Recruiting
Address
Fakultni nemocnice Olomouc
Olomouc, , 775 20
Status
Recruiting
Address
Vseobecna fakultni nemocnice v Praze
Praha 2, , 128 08
Status
Recruiting
Address
Helsingin Yliopistollinen Keskussairaala
Helsinki, , 00290
Status
Recruiting
Address
Oulun Yliopistollinen Sairaala
Oulu, , 90220
Status
Recruiting
Address
Turun Yliopistollinen Keskussairaala
Turku, , 20521
Status
Recruiting
Address
Centre Hospitalier Universitaire de Nantes
Nantes, , 44000
Status
Recruiting
Address
Centre Hospitalier Universitaire Archet 2
Nice cedex 3, , 06202
Status
Recruiting
Address
Hopital Saint Louis
Paris, , 75010
Status
Recruiting
Address
Hopital Pitie-Salpetriere
Paris, , 75013
Status
Recruiting
Address
Centre Hospitalier Lyon Sud
Pierre-Benite, , 69495
Status
Recruiting
Address
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers Cedex, , 86021
Status
Completed
Address
Centre Hospitalier Universitaire de Rennes
Rennes, , 35033
Status
Recruiting
Address
Institut de Cancerologie Strasbourg
Strasbourg, , 67033
Status
Recruiting
Address
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse cedex 9, , 31059
Status
Recruiting
Address
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
Vandoeuvre les Nancy Cedex, , 54511
Status
Recruiting
Address
Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin
Berlin, , 12200
Status
Recruiting
Address
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
Dresden, , 01307
Status
Recruiting
Address
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , 20246
Status
Recruiting
Address
Universitatsklinikum Koln
Köln, , 50924
Status
Recruiting
Address
Johannes Gutenberg Universitaet Mainz
Mainz, , 55131
Status
Recruiting
Address
University Hospital of Alexandroupolis
Alexandroupoli, , 68100
Status
Recruiting
Address
General Hospital Evangelismos
Athens, , 10676
Status
Recruiting
Address
Agios Savvas Anticancer Hospital
Athens, , 115 22
Status
Recruiting
Address
251 General Airforce Hospital
Athens, , 11525
Status
Recruiting
Address
Alexandra Hospital
Athens, , 11528
Status
Recruiting
Address
Metropolitan Hospital
Athens, , 18547
Status
Recruiting
Address
General University Hospital of Patras Panagia i Voithia
Patra, , 26504
Status
Recruiting
Address
Theagenion Cancer Hospital of Thessaloniki
Thessaloniki, , 54007
Status
Recruiting
Address
General Hospital of Thessaloniki Georgios Papanikolaou
Thessaloniki, , 57010
Status
Recruiting
Address
Nagoya City University Hospital
Nagoya-shi, Aichi, 467-8602
Status
Recruiting
Address
Toyohashi Municipal Hospital
Toyohashi-shi, Aichi, 441-8570
Status
Recruiting
Address
Tesshokai Kameda General Hospital
Kamogawa-shi, Chiba, 296-8602
Status
Recruiting
Address
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi, Fukuoka, 811-1395
Status
Recruiting
Address
Ogaki Municipal Hospital
Ogaki-shi, Gifu, 503-8502
Status
Recruiting
Address
National Hospital Organization Shibukawa Medical Center
Shibukawa-shi, Gunma, 377-0280
Status
Recruiting
Address
Japanese Red Cross Society Himeji Hospital
Himeji-shi, Hyogo, 670-8540
Status
Recruiting
Address
Hyogo College of Medicine Hospital
Nishinomiya-shi, Hyogo, 663-8501
Status
Recruiting
Address
Hitachi Ltd Hitachi General Hospital
Hitachi-shi, Ibaraki, 317-0077
Status
Recruiting
Address
University Hospital Kyoto Prefectural University of Medicine
Kyoto-shi, Kyoto, 602-8566
Status
Recruiting
Address
National Hospital Organization Sendai Medical Center
Sendai-shi, Miyagi, 983-8520
Status
Recruiting
Address
Niigata Cancer Center Hospital
Niigata-shi, Niigata, 951-8566
Status
Recruiting
Address
National Hospital Organization Okayama Medical Center
Okayama-shi, Okayama, 701-1192
Status
Recruiting
Address
Japanese Red Cross Osaka Hospital
Osaka-shi, Osaka, 543-8555
Status
Recruiting
Address
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
Status
Recruiting
Address
Osaka University Hospital
Suita-shi, Osaka, 565-0871
Status
Recruiting
Address
Saitama Medical Center
Kawagoe-shi, Saitama, 350-8550
Status
Terminated
Address
Tochigi Cancer Center
Utsunomiya-shi, Tochigi, 320-0834
Status
Recruiting
Address
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Status
Recruiting
Address
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Status
Recruiting
Address
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935
Status
Completed
Address
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
Kaunas, , 50009
Status
Recruiting
Address
Vilnius University Hospital Santaros Clinic Public Institution
Vilnius, , 08661
Status
Recruiting
Address
VU Medisch Centrum
Amsterdam, , 1081 HV
Status
Recruiting
Address
Gelre Ziekenhuizen
Apeldoorn, , 7334 DZ
Status
Recruiting
Address
Spaarne Gasthuis
Hoofddorp, , 2134 TM
Status
Recruiting
Address
Fundeni Clinical Institute
Bucharest, , 022328
Status
Recruiting
Address
Institutul Clinic Fundeni
Bucharest, , 022328
Status
Recruiting
Address
Spitalul Clinic Coltea
Bucharest, , 030171
Status
Recruiting
Address
Spitalul Universitar de Urgenta Bucuresti
Bucharest, , 050098
Status
Recruiting
Address
Spitalul Clinic Colentina
Bucuresti, , 020125
Status
Recruiting
Address
Institutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca, , 400015
Status
Recruiting
Address
Institutul Regional de Oncologie Iasi
Iasi, , 700483
Status
Recruiting
Address
Spitalul Clinic Dr Gavril Curteanu Oradea
Oradea, , 410469
Status
Recruiting
Address
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, , 550245
Status
Recruiting
Address
Spitalul Clinic Municipal de Urgenta Timisoara
Timisoara, , 300079
Status
Recruiting
Address
Regional Clinical Hospital
Krasnoyarsk, , 660022
Status
Recruiting
Address
Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department
Moscow, , 123182
Status
Recruiting
Address
SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department
Moscow, , 125284
Status
Recruiting
Address
SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov
Petrozavodsk, , 185019
Status
Recruiting
Address
Federal centre of heart, blood and endocrinology Almazova
Saint Petersburg, , 197341
Status
Recruiting
Address
State Budget Educational Institution of High Professional Skills Samara State Medical University
Samara, , 443079
Status
Recruiting
Address
Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda
Bratislava, , 851 07
Status
Recruiting
Address
Hospital Universitari Son Espases
Palma de Mallorca, Baleares, 07010
Status
Recruiting
Address
Hospital Clinico Universitario de Salamanca
Salamanca, Castilla León, 37007
Status
Recruiting
Address
Hospital Universitari Germans Trias i Pujol
Badalona, Cataluña, 08916
Status
Recruiting
Address
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña, 08036
Status
Recruiting
Address
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, Madrid, 28223
Status
Recruiting
Address
Clinica Universidad de Navarra
Pamplona, Navarra, 31008
Status
Recruiting
Address
Sahlgrenska Universitetssjukhuset
Goteborg, , 413 45
Status
Terminated
Address
Hallands Sjukhus Halmstad
Halmstad, , 301 85
Status
Recruiting
Address
Sunderby Sjukhus
Lulea, , 971 80
Status
Recruiting
Address
Skanes Universitetssjukhus
Lund, , 221 85
Status
Recruiting
Address
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, , 06560
Status
Recruiting
Address
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara, , 06590
Status
Recruiting
Address
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, , 34093
Status
Recruiting
Address
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, , 34214
Status
Recruiting
Address
Istanbul Florence Nightingale Hastanesi
Istanbul, , 34387
Status
Recruiting
Address
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi
Izmir, , 35340
Status
Recruiting
Address
Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi
Kayseri, , 38039