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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 107 Locations for this study
Fountain Valley California, 92708, United States
Denver Colorado, 80218, United States
Plainville Connecticut, 06062, United States
Jacksonville Florida, 32207, United States
Park Ridge Illinois, 60068, United States
Albany New York, 12208, United States
Cincinnati Ohio, 45242, United States
Denton Texas, 76201, United States
Fort Worth Texas, 76177, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
The Woodlands Texas, 77380, United States
Salzburg , 5020, Austria
Plovdiv , 4002, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1756, Bulgaria
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 775 2, Czechia
Praha 2 , 128 0, Czechia
Helsinki , 00290, Finland
Oulu , 90220, Finland
Turku , 20521, Finland
Nantes , 44000, France
Nice cedex 3 , 06202, France
Paris , 75010, France
Paris , 75013, France
Pierre-Benite , 69495, France
Poitiers Cedex , 86021, France
Rennes , 35033, France
Strasbourg , 67033, France
Toulouse cedex 9 , 31059, France
Vandoeuvre les Nancy Cedex , 54511, France
Berlin , 12200, Germany
Dresden , 01307, Germany
Hamburg , 20246, Germany
Köln , 50924, Germany
Mainz , 55131, Germany
Alexandroupoli , 68100, Greece
Athens , 10676, Greece
Athens , 115 2, Greece
Athens , 11525, Greece
Athens , 11528, Greece
Athens , 18547, Greece
Patra , 26504, Greece
Thessaloniki , 54007, Greece
Thessaloniki , 57010, Greece
Nagoya-shi Aichi, 467-8, Japan
Toyohashi-shi Aichi, 441-8, Japan
Kamogawa-shi Chiba, 296-8, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Ogaki-shi Gifu, 503-8, Japan
Shibukawa-shi Gunma, 377-0, Japan
Himeji-shi Hyogo, 670-8, Japan
Nishinomiya-shi Hyogo, 663-8, Japan
Hitachi-shi Ibaraki, 317-0, Japan
Kyoto-shi Kyoto, 602-8, Japan
Sendai-shi Miyagi, 983-8, Japan
Niigata-shi Niigata, 951-8, Japan
Okayama-shi Okayama, 701-1, Japan
Osaka-shi Osaka, 543-8, Japan
Osakasayama-shi Osaka, 589-8, Japan
Suita-shi Osaka, 565-0, Japan
Kawagoe-shi Saitama, 350-8, Japan
Utsunomiya-shi Tochigi, 320-0, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Koto-ku Tokyo, 135-8, Japan
Shibuya-ku Tokyo, 150-8, Japan
Kaunas , 50009, Lithuania
Vilnius , 08661, Lithuania
Amsterdam , 1081 , Netherlands
Apeldoorn , 7334 , Netherlands
Hoofddorp , 2134 , Netherlands
Bucharest , 02232, Romania
Bucharest , 02232, Romania
Bucharest , 03017, Romania
Bucharest , 05009, Romania
Bucuresti , 02012, Romania
Cluj-Napoca , 40001, Romania
Iasi , 70048, Romania
Oradea , 41046, Romania
Sibiu , 55024, Romania
Timisoara , 30007, Romania
Krasnoyarsk , 66002, Russian Federation
Moscow , 12318, Russian Federation
Moscow , 12528, Russian Federation
Petrozavodsk , 18501, Russian Federation
Saint Petersburg , 19734, Russian Federation
Samara , 44307, Russian Federation
Bratislava , 851 0, Slovakia
Palma de Mallorca Baleares, 07010, Spain
Salamanca Castilla León, 37007, Spain
Badalona Cataluña, 08916, Spain
Barcelona Cataluña, 08036, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Pamplona Navarra, 31008, Spain
Falun , 791 8, Sweden
Goteborg , 413 4, Sweden
Halmstad , 301 8, Sweden
Lulea , 971 8, Sweden
Lund , 221 8, Sweden
Ankara , 06560, Turkey
Ankara , 06590, Turkey
Istanbul , 34093, Turkey
Istanbul , 34214, Turkey
Istanbul , 34387, Turkey
Izmir , 35340, Turkey
Kayseri , 38039, Turkey
How clear is this clinincal trial information?