Multiple myeloma MedDRA version: 12.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Product Name: Carfilzomib
Product Code: PR-171
Pharmaceutical Form: Powder for solution for injection
CAS Number: 868540-17-4
Current Sponsor code: PR-171
Other descriptive name: carfilzomib
506160
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Trade Name: Fortecortin® 2mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Dexamethasone
CA
Sponsors
Onyx Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease-related: * Multiple myeloma * Measurable disease, as defined by one or both of the following (assessed within 14 days prior to randomization): - Serum M-protein = 0.5 g/dL - Urine Bence-Jones protein = 200 mg/24 hours * Responsive (defined by a 25% or greater decrease in M-protein or total protein) to at least one line of prior therapy * Refractory to most recent therapy (defined as disease progression during treatment or within 60 days after discontinuation of treatment) * Received 3 or more prior therapeutic regimens for multiple myeloma * Adequate prior treatment with bortezomib (if less than 4 cycles, the reason for discontinuation must be reviewed by the Medical Monitor) * Prior treatment with an immunomodulatory agent (lenalidomide if available, and/or thalidomide) * Prior treatment with an alkylating agent (standard or high-dose) * Prior treatment with a corticosteroid * Prior treatment with an anthracycline unless not clinically indicated (eg, cardiac disease) Demographic * Age = 18 years * Life expectancy of at least 1 month * Eastern Cooperative Oncology Group (ECOG) performance status 0–3 Laboratory * Adequate hepatic function, with serum ALT 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. * Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease-related * Waldenström’s macroglobulinemia or IgM myeloma * Refractory to all prior therapies * Disease measurable only by serum free light chain assay (SFLC) * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential) * Prior carfilzomib treatment Concurrent Treatments * Chemotherapy (approved or investigational) within 2 weeks prior to randomization * Immunotherapy or antibody therapy within 4 weeks prior to randomization * High-dose corticosteroids (eg, dexamethasone = 20 mg/day or prednisolone = 100 mg/day) at any time within 2 weeks prior to randomization * Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization Concurrent Conditions * Major surgery within 21 days prior to randomization * Congestive heart failure (NYHA Class III or IV) or symptomatic cardiac ischemia, conduction system abnormalities uncontrolled by conventional intervention (conduction abnormalities not clinically warranting intervention are allowed) * Myocardial infarction in the previous 3 months * Acute active infection requiring systemic treatment (antibiotics, antivirals, or antifungals) within 14 days prior to randomization * Known human immunodeficiency virus seropositivity * Active hepatitis A, B, or C infection * Other malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix, vulva, or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, carcinoma in situ of the breast, or benign tumors of the adrenal or pancreas * Significant neuropathy (Grades 3–4, or Grade 2 with pain) at the time of randomization * Any other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent *Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare progression free survival (PFS) in subjects with refactory multiple myeloma relapsed after at least 3 prior regimens who are randomized to receive either carfilzomib alone or best supportive care.;Secondary Objective: Secondary objectives include investigating the effect of carfilzomib on other standard efficacy variables including overall survival (OS), overall response rate (ORR) (sCR + CR + VGPR + PR), clinical benefit rate (CBR) (ORR + MR), disease control rate (DCR) (CBR + stable disease lasting for at least 8 weeks), duration of response (DOR), and safety.;Primary end point(s): Progression free survival (PFS) | — |
Countries
Austria, Belgium, Czech Republic, Germany, Greece, Hungary, Italy, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed