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

Study Purpose

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.

Recruitment Criteria

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
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Documented relapse or progressive multiple myeloma after last treatment. Subjects refractory to the most recent line of therapy are eligible, unless last treatment contained 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 therapy with a PI or lenalidomide and dexamethasone, neither PI or lenalidomide and dexamethasone in combination were ceased due to toxicity (unless at the time of enrollment that toxicity was neuropathy not exceeding grade 2 which has either resolved or if ongoing is less than or equal to grade 1), the patient has not received a PI and has not received lenalidomide and dexamethasone in combination in the 6 months prior to first study treatment. (Patients are permitted to have received single agent lenalidomide as maintenance therapy during the 6 months prior to first treatment) 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:
  • - Inmunoglobulin G (IgG) multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL.
  • - Inmunoglobulin A (IgA), Inmunoglobulin D (IgD), Inmunoglobulin 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 Inmunoglobulin 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 exceeds ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic when taken in accordance with the European Society of Hypertension/European Society of Cardiology 2018 guidelines. 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 < 1.0 mL/s (calculation must be based on the Cockcroft and Gault formula) within 21 days prior to randomization. Other exclusion criteria may apply

Trial Details

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
Arms & Interventions

Arms

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

Interventions

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

Contact a Trial Team

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.

Robert A Moss Oncology, Fountain Valley, California

Status

Terminated

Address

Robert A Moss Oncology

Fountain Valley, California, 92708

Denver, Colorado

Status

Terminated

Address

Rocky Mountain Cancer Centers Denver Midtown

Denver, Colorado, 80218

Plainville, Connecticut

Status

Terminated

Address

Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

Plainville, Connecticut, 06062

Baptist MD Anderson Cancer Center, Jacksonville, Florida

Status

Terminated

Address

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207

Advocate Lutheran General Hospital, Park Ridge, Illinois

Status

Terminated

Address

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

New York Oncology Hematology, PC, Albany, New York

Status

Terminated

Address

New York Oncology Hematology, PC

Albany, New York, 12208

Oncology Hematology Care Inc, Cincinnati, Ohio

Status

Recruiting

Address

Oncology Hematology Care Inc

Cincinnati, Ohio, 45242

Texas Oncology, Denton, Texas

Status

Terminated

Address

Texas Oncology

Denton, Texas, 76201

Fort Worth, Texas

Status

Recruiting

Address

US Oncology Research Investigational Products Center

Fort Worth, Texas, 76177

Oncology Consultants PA, Houston, Texas

Status

Terminated

Address

Oncology Consultants PA

Houston, Texas, 77030

Texas Oncology, San Antonio, Texas

Status

Terminated

Address

Texas Oncology

San Antonio, Texas, 78229

The Woodlands, Texas

Status

Recruiting

Address

United States Oncology Regulatory Affairs Corporate Office

The Woodlands, Texas, 77380

International Sites

Universitaetsklinikum Salzburg, Salzburg, Austria

Status

Recruiting

Address

Universitaetsklinikum Salzburg

Salzburg, , 5020

Plovdiv, Bulgaria

Status

Recruiting

Address

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

Plovdiv, , 4002

Sofia, Bulgaria

Status

Recruiting

Address

University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

Sofia, , 1431

Sofia, Bulgaria

Status

Recruiting

Address

Specialized Hospital for Active Treatment of Hematology Diseases EAD

Sofia, , 1756

Fakultni nemocnice Brno, Brno, Czechia

Status

Recruiting

Address

Fakultni nemocnice Brno

Brno, , 625 00

Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czechia

Status

Recruiting

Address

Fakultni nemocnice Hradec Kralove

Hradec Kralove, , 500 05

Fakultni nemocnice Olomouc, Olomouc, Czechia

Status

Recruiting

Address

Fakultni nemocnice Olomouc

Olomouc, , 775 20

Vseobecna fakultni nemocnice v Praze, Praha 2, Czechia

Status

Recruiting

Address

Vseobecna fakultni nemocnice v Praze

Praha 2, , 128 08

Helsingin Yliopistollinen Keskussairaala, Helsinki, Finland

Status

Recruiting

Address

Helsingin Yliopistollinen Keskussairaala

Helsinki, , 00290

Oulun Yliopistollinen Sairaala, Oulu, Finland

Status

Recruiting

Address

Oulun Yliopistollinen Sairaala

Oulu, , 90220

Turun Yliopistollinen Keskussairaala, Turku, Finland

Status

Recruiting

Address

Turun Yliopistollinen Keskussairaala

Turku, , 20521

Nantes, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Nantes

Nantes, , 44000

Nice cedex 3, France

Status

Recruiting

Address

Centre Hospitalier Universitaire Archet 2

Nice cedex 3, , 06202

Hopital Saint Louis, Paris, France

Status

Recruiting

Address

Hopital Saint Louis

Paris, , 75010

Hopital Pitie-Salpetriere, Paris, France

Status

Recruiting

Address

Hopital Pitie-Salpetriere

Paris, , 75013

Centre Hospitalier Lyon Sud, Pierre-Benite, France

Status

Recruiting

Address

Centre Hospitalier Lyon Sud

Pierre-Benite, , 69495

Poitiers Cedex, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

Poitiers Cedex, , 86021

Rennes, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Rennes

Rennes, , 35033

Institut de Cancerologie de Strasbourg, Strasbourg, France

Status

Recruiting

Address

Institut de Cancerologie de Strasbourg

Strasbourg, , 67033

Toulouse cedex 9, France

Status

Recruiting

Address

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse cedex 9, , 31059

Vandoeuvre les Nancy Cedex, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

Vandoeuvre les Nancy Cedex, , 54511

Berlin, Germany

Status

Recruiting

Address

Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin

Berlin, , 12200

Dresden, Germany

Status

Recruiting

Address

Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden

Dresden, , 01307

Universitatsklinikum Hamburg-Eppendorf, Hamburg, Germany

Status

Recruiting

Address

Universitatsklinikum Hamburg-Eppendorf

Hamburg, , 20246

Universitatsklinikum Koln, Köln, Germany

Status

Recruiting

Address

Universitatsklinikum Koln

Köln, , 50924

Johannes Gutenberg Universitat Mainz, Mainz, Germany

Status

Recruiting

Address

Johannes Gutenberg Universitat Mainz

Mainz, , 55131

University Hospital of Alexandroupolis, Alexandroupoli, Greece

Status

Recruiting

Address

University Hospital of Alexandroupolis

Alexandroupoli, , 68100

General Hospital Evangelismos, Athens, Greece

Status

Recruiting

Address

General Hospital Evangelismos

Athens, , 10676

Agios Savvas Anticancer Hospital, Athens, Greece

Status

Recruiting

Address

Agios Savvas Anticancer Hospital

Athens, , 115 22

251 General Airforce Hospital, Athens, Greece

Status

Recruiting

Address

251 General Airforce Hospital

Athens, , 11525

Alexandra Hospital, Athens, Greece

Status

Recruiting

Address

Alexandra Hospital

Athens, , 11528

Metropolitan Hospital, Athens, Greece

Status

Recruiting

Address

Metropolitan Hospital

Athens, , 18547

Patra, Greece

Status

Recruiting

Address

General University Hospital of Patras Panagia i Voithia

Patra, , 26504

Thessaloniki, Greece

Status

Recruiting

Address

Theagenion Cancer Hospital of Thessaloniki

Thessaloniki, , 54007

Thessaloniki, Greece

Status

Recruiting

Address

General Hospital of Thessaloniki Georgios Papanikolaou

Thessaloniki, , 57010

Nagoya City University Hospital, Nagoya-shi, Aichi, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya-shi, Aichi, 467-8602

Toyohashi Municipal Hospital, Toyohashi-shi, Aichi, Japan

Status

Recruiting

Address

Toyohashi Municipal Hospital

Toyohashi-shi, Aichi, 441-8570

Tesshokai Kameda General Hospital, Kamogawa-shi, Chiba, Japan

Status

Recruiting

Address

Tesshokai Kameda General Hospital

Kamogawa-shi, Chiba, 296-8602

Fukuoka-shi, Fukuoka, Japan

Status

Recruiting

Address

National Hospital Organization Kyushu Cancer Center

Fukuoka-shi, Fukuoka, 811-1395

Ogaki Municipal Hospital, Ogaki-shi, Gifu, Japan

Status

Recruiting

Address

Ogaki Municipal Hospital

Ogaki-shi, Gifu, 503-8502

Shibukawa-shi, Gunma, Japan

Status

Recruiting

Address

National Hospital Organization Shibukawa Medical Center

Shibukawa-shi, Gunma, 377-0280

Himeji-shi, Hyogo, Japan

Status

Recruiting

Address

Japanese Red Cross Society Himeji Hospital

Himeji-shi, Hyogo, 670-8540

Hyogo College of Medicine Hospital, Nishinomiya-shi, Hyogo, Japan

Status

Recruiting

Address

Hyogo College of Medicine Hospital

Nishinomiya-shi, Hyogo, 663-8501

Hitachi Ltd Hitachi General Hospital, Hitachi-shi, Ibaraki, Japan

Status

Recruiting

Address

Hitachi Ltd Hitachi General Hospital

Hitachi-shi, Ibaraki, 317-0077

Kyoto-shi, Kyoto, Japan

Status

Recruiting

Address

University Hospital Kyoto Prefectural University of Medicine

Kyoto-shi, Kyoto, 602-8566

Sendai-shi, Miyagi, Japan

Status

Recruiting

Address

National Hospital Organization Sendai Medical Center

Sendai-shi, Miyagi, 983-8520

Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan

Status

Recruiting

Address

Niigata Cancer Center Hospital

Niigata-shi, Niigata, 951-8566

Okayama-shi, Okayama, Japan

Status

Recruiting

Address

National Hospital Organization Okayama Medical Center

Okayama-shi, Okayama, 701-1192

Japanese Red Cross Osaka Hospital, Osaka-shi, Osaka, Japan

Status

Recruiting

Address

Japanese Red Cross Osaka Hospital

Osaka-shi, Osaka, 543-8555

Kindai University Hospital, Osakasayama-shi, Osaka, Japan

Status

Recruiting

Address

Kindai University Hospital

Osakasayama-shi, Osaka, 589-8511

Osaka University Hospital, Suita-shi, Osaka, Japan

Status

Recruiting

Address

Osaka University Hospital

Suita-shi, Osaka, 565-0871

Saitama Medical Center, Kawagoe-shi, Saitama, Japan

Status

Recruiting

Address

Saitama Medical Center

Kawagoe-shi, Saitama, 350-8550

Tochigi Cancer Center, Utsunomiya-shi, Tochigi, Japan

Status

Terminated

Address

Tochigi Cancer Center

Utsunomiya-shi, Tochigi, 320-0834

Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan

Status

Recruiting

Address

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431

Koto-ku, Tokyo, Japan

Status

Recruiting

Address

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, 135-8550

Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan

Status

Recruiting

Address

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, 150-8935

Kaunas, Lithuania

Status

Recruiting

Address

Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

Kaunas, , 50009

Vilnius, Lithuania

Status

Recruiting

Address

Vilnius University Hospital Santaros Clinic Public Institution

Vilnius, , 08661

VU Medisch Centrum, Amsterdam, Netherlands

Status

Recruiting

Address

VU Medisch Centrum

Amsterdam, , 1081 HV

Gelre Ziekenhuizen, Apeldoorn, Netherlands

Status

Recruiting

Address

Gelre Ziekenhuizen

Apeldoorn, , 7334 DZ

Spaarne Gasthuis, Hoofddorp, Netherlands

Status

Recruiting

Address

Spaarne Gasthuis

Hoofddorp, , 2134 TM

Fundeni Clinical Institute, Bucharest, Romania

Status

Recruiting

Address

Fundeni Clinical Institute

Bucharest, , 022328

Institutul Clinic Fundeni, Bucharest, Romania

Status

Recruiting

Address

Institutul Clinic Fundeni

Bucharest, , 022328

Spitalul Clinic Coltea, Bucharest, Romania

Status

Recruiting

Address

Spitalul Clinic Coltea

Bucharest, , 030171

Bucharest, Romania

Status

Recruiting

Address

Spitalul Universitar de Urgenta Bucuresti

Bucharest, , 050098

Spitalul Clinic Colentina, Bucuresti, Romania

Status

Recruiting

Address

Spitalul Clinic Colentina

Bucuresti, , 020125

Cluj-Napoca, Romania

Status

Recruiting

Address

Institutul Oncologic Prof Dr Ion Chiricuta

Cluj-Napoca, , 400124

Institutul Regional de Oncologie Iasi, Iasi, Romania

Status

Recruiting

Address

Institutul Regional de Oncologie Iasi

Iasi, , 700483

Oradea, Romania

Status

Recruiting

Address

Spitalul Clinic Dr Gavril Curteanu Oradea

Oradea, , 410469

Sibiu, Romania

Status

Recruiting

Address

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, , 550245

Timisoara, Romania

Status

Recruiting

Address

Spitalul Clinic Municipal de Urgenta Timisoara

Timisoara, , 300079

Regional Clinical Hospital, Krasnoyarsk, Russian Federation

Status

Recruiting

Address

Regional Clinical Hospital

Krasnoyarsk, , 660022

Moscow, Russian Federation

Status

Recruiting

Address

Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department

Moscow, , 123182

Moscow, Russian Federation

Status

Recruiting

Address

SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department

Moscow, , 125284

Petrozavodsk, Russian Federation

Status

Recruiting

Address

SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov

Petrozavodsk, , 185019

Saint Petersburg, Russian Federation

Status

Recruiting

Address

Federal centre of heart, blood and endocrinology Almazova

Saint Petersburg, , 197341

Samara, Russian Federation

Status

Recruiting

Address

State Budget Educational Institution of High Professional Skills Samara State Medical University

Samara, , 443079

Bratislava, Slovakia

Status

Recruiting

Address

Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda

Bratislava, , 851 07

Hospital Universitari Son Espases, Palma de Mallorca, Baleares, Spain

Status

Recruiting

Address

Hospital Universitari Son Espases

Palma de Mallorca, Baleares, 07010

Salamanca, Castilla León, Spain

Status

Recruiting

Address

Hospital Clinico Universitario de Salamanca

Salamanca, Castilla León, 37007

Badalona, Cataluña, Spain

Status

Recruiting

Address

Hospital Universitari Germans Trias i Pujol

Badalona, Cataluña, 08916

Barcelona, Cataluña, Spain

Status

Recruiting

Address

Hospital Clinic i Provincial de Barcelona

Barcelona, Cataluña, 08036

Pozuelo de Alarcon, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcon, Madrid, 28223

Clinica Universidad de Navarra, Pamplona, Navarra, Spain

Status

Recruiting

Address

Clinica Universidad de Navarra

Pamplona, Navarra, 31008

Falu Lasarett, Falun, Sweden

Status

Recruiting

Address

Falu Lasarett

Falun, , 791 82

Sahlgrenska Universitetssjukhuset, Goteborg, Sweden

Status

Recruiting

Address

Sahlgrenska Universitetssjukhuset

Goteborg, , 413 45

Hallands Sjukhus Halmstad, Halmstad, Sweden

Status

Terminated

Address

Hallands Sjukhus Halmstad

Halmstad, , 301 85

Sunderby Sjukhus, Lulea, Sweden

Status

Recruiting

Address

Sunderby Sjukhus

Lulea, , 971 80

Skanes Universitetssjukhus, Lund, Sweden

Status

Recruiting

Address

Skanes Universitetssjukhus

Lund, , 221 85

Ankara, Turkey

Status

Recruiting

Address

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, , 06560

Ankara, Turkey

Status

Recruiting

Address

Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

Ankara, , 06590

Istanbul, Turkey

Status

Recruiting

Address

Istanbul Universitesi Istanbul Tip Fakultesi

Istanbul, , 34093

Istanbul, Turkey

Status

Recruiting

Address

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, , 34214

Istanbul Florence Nightingale Hastanesi, Istanbul, Turkey

Status

Recruiting

Address

Istanbul Florence Nightingale Hastanesi

Istanbul, , 34387

Izmir, Turkey

Status

Recruiting

Address

Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

Izmir, , 35340

Kayseri, Turkey

Status

Recruiting

Address

Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi

Kayseri, , 38039