First-Line Multiple Myeloma
Conditions
Interventions
Trade Name: Decortin
Product Name: Decortin, prednisone 5 mg tablets for oral use
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisone
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Janssen-Cilag Kft.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female Subject is not a candidate for HDT/SCT due to: age - subject is 65 years or older. OR in subjects less than 65 years of age - presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT/SCT. Sponsor review of these comorbid conditions and approval is required before randomization. Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage. Asymptomatic multiple myeloma-related organ or tissue damage can include presence of asymptomatic lytic bone lesion or plasmacytoma, or presence of anemia (hemoglobin upper limit of normal [ULN]) or hypercalcemia (serum calcium >ULN), as long as the criteria for pre-treatment clinical laboratory values indicated below are met. Presence of measurable disease, defined as: For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (>1 g/dL of IgG or IgM M-protein, >0.5 g/dL of IgA M-protein, >0.05 g/dL of IgD M protein, OR urine light-chain excretion of more than 200 mg/24 hours). For oligosecretory or nonsecretory multiple myeloma, measurable disease is defined by the presence of measurable soft tissue or organ (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e., magnetic resonance imaging [MRI], computed tomography [CT] scan). A measurable lesion is defined as a lesion with minimum largest diameter of >20 mm (if measured by conventional techniques such as physical examination, conventional CT scan, or MRI) or of >10 mm (if measured by spiral CT scan) in one dimension. Oligosecretory myeloma is defined as the presence of M-protein in serum or urine but in quantities less than indicated above. Nonsecretory multiple myeloma is defined as the absence of M protein in serum and in urine by immunofixation. Karnofsky performance status score >60% Have pretreatment clinical laboratory values meeting the following criteria within 14 days before randomization: -platelet count greater or equal to 100x10*9/L -hemoglobin greater or equal than 8 g/dL (greater or equal than 4.96 mmol/L) (prior RBC transfusion or recombinant human erythropoietin use is allowed) -absolute neutrophil count (ANC) greater or equal than 1.0x109/L -aspartate aminotransferase (AST) smaller or equal than 2.5 times the upper limit of normal -total bilirubin lower or equal than 1.5 times the upper limit of normal -serum creatinine smaller or equal to 2mg/dL (smaller or equal to176.8 mcmol/L) -corrected serum calcium =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Diagnosis of smoldering multiple myeloma or MGUS. Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of lytic bone lesions. MGUS is defined by presence of serum monoclonal protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the monoclonal protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less. Diagnosis of Waldenstrom's disease or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions. Prior or current systemic therapy for multiple myeloma including steroids (with exception of emergency use of a short course [maximum 4 days] of steroids before randomization or of prior or current use of bisphosphonates) Radiation therapy within 30 days before randomization Plasmapheresis within 30 days before randomization Major surgery within 30 days before randomization (Kyphoplasty is not considered major surgery) History of allergic reaction attributable to compounds containing boron or mannitol Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (see Attachment 3), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis Other malignancy within the past 5 years. Exceptions for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix Concurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study Use of any investigational drugs within 30 days before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective of this study is to determine whether the addition of VELCADE to standard MP therapy improves the TTP in subjects with previously untreated multiple myeloma. ;Secondary Objective: The secondary objectives of this study are to determine whether the addition of VELCADE to standard MP therapy in subjects with previously untreated multiple myeloma improves the following: OS, CR rate, overall response rate (CR + PR), time to response, and duration of response. An additional secondary objective is to measure and test global health status as measured by the EORTC QLQ-C30, a patient-reported outcome (PCO) instrument. ;Primary end point(s): The primary end point of this study is TTP in the intent-to-treat subject population. Time to progression is a meaningful end point in an elderly patient population with multiple myeloma for whom currently available treatment options are not curative and can only delay disease progression. Overall survival was chosen only as a secondary end point due to the likelihood of cross-over of subjects on the control arm to commercially available VELCADE or a VELCADE-containing regimen as subsequent therapy. | — |
Countries
Belgium, Czech Republic, Finland, Germany, Hungary, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed