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

Completed · Phase 3

Conditions studied: Relapsed or Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT03859427
Run by: Amgen
People needed: 454
Starts: 2019-05-08
Expected to finish: 2023-03-31
Last updated by the study team: 2024-08-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Rocky Mountain Cancer Centers Denver Midtown — Denver, Colorado, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut — Plainville, Connecticut, United States
Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
New York Oncology Hematology, PC — Albany, New York, United States
Oncology Hematology Care Inc — Cincinnati, Ohio, United States
Texas Oncology-Denton — Denton, Texas, United States
US Oncology Research Investigational Products Center — Fort Worth, Texas, United States
Oncology Consultants PA — Houston, Texas, United States
Texas Oncology — San Antonio, Texas, United States
United States Oncology Regulatory Affairs Corporate Office — The Woodlands, Texas, United States
Universitaetsklinikum Salzburg — Salzburg, Austria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD — Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD — Sofia, Bulgaria
Specialized Hospital for Active Treatment of Hematology Diseases EAD — Sofia, Bulgaria
Fakultni nemocnice Brno — Brno, Czechia
Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia
Fakultni nemocnice Olomouc — Olomouc, Czechia
Vseobecna fakultni nemocnice v Praze — Prague, Czechia
Helsingin Yliopistollinen Keskussairaala — Helsinki, Finland
Oulun Yliopistollinen Sairaala — Oulu, Finland
Turun Yliopistollinen Keskussairaala — Turku, Finland
Centre Hospitalier Universitaire de Nantes — Nantes, France
Centre Hospitalier Universitaire Archet 2 — Nice, France
Robert A Moss Oncology — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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