Myeloma related bone disease MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: VELCADE
Product Name: VELCADE
Product Code: VELCADE (Bortezomib)
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: VELCADE (bortezomib)
CAS Number: 179324-69-7
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Sponsors
Janssen-Cilag EMEA Medical Affairs
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Man or woman over 18 years of age 2. Response of PR or better after receiving high-dose chemotherapy followed by autologous stem cell transplantation (single- or double transplant) as primary therapy of the disease. Date of hospital discharge from stem cell transplantation has to be at least 60 days and within 120 days prior to randomization. 3. Karnofsky performance status of = 60 4. Life expectancy estimated at screening of at least 12 months 5. Following pre-treatment laboratory criteria at and within 14 days before baseline (Day 1 of Cycle 1, before study drug administration): Platelet count = 50x 109/L without transfusion support within the 7 days before the test Haemoglobin = 7.5 g/dL without transfusion support within the 7 days before the test Absolute neutrophil count (ANC) = 0.75 x10 9/L without the use of colony stimulating factors within 14 days before the test Corrected serum calcium =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1.Received another antimyeloma or experimental therapy following autologous stem cell transplantation 2.Known allergies, hypersensitivity, or intolerance to study drug or its excipients 3.[Exclusion criterion no. 3 is deleted] 4.Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined by the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE), version 3.0 5.Myocardial infarction within 6 months of enrolment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 6.Poorly controlled hypertension, diabetes mellitus, or other serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections, etc) or psychiatric illness likely to interfere with participation in this clinical study 7.Treated for a cancer other than multiple myeloma within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ 8.Known to be human immunodeficiency virus (HIV)-positive (Subjects assessed by the investigator to be at risk for HIV infection should be tested in accordance with local policies.) 9.Known to be hepatitis B surface antigen-positive or known active hepatitis C infection (Subjects assessed by the investigator to be at risk for hepatitis B or C infection are to be tested in accordance with local regulations.) 10.Active systemic infection requiring treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the effect of bortezomib on myeloma related bone disease by analyzing bone mineral density (BMD).;Secondary Objective: The secondary objectives are assessment of safety profile and additional efficacy parameters including change in BMD over time, biochemical bone markers, Karnofsky performance status, skeletal events, appearance of new bone lesions, quality of life assessment, progression-free survival, the overall survival, and the respective one-year survival of the subjects treated with Velcade® or observation.;Primary end point(s): The primary efficacy criterion will be effect of bortezomib on myeloma related bone disease as measured by the change in bone mineral density (BMD) at EOT Visit compared to the baseline value. It is expected that at EOT Visit bone mineral density will be reduced to a greater extent compared to baseline in the untreated group versus subjects treated with Velcade® assuming no significant differences between both groups at baseline. | — |
Countries
Austria, Czech Republic, Denmark, Germany, Greece, Sweden, United Kingdom
Outcome results
None listed