Mieloma Múltiple Sintomático MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Product Name: CNTO 328
Product Code: CNTO 328
Pharmaceutical Form: Solution for infusion
Current Sponsor code: CNTO 328
Other descriptive name: Chimeric murine human anti-IL6 Monocolonal Antibody
Conc
Sponsors
Centocor BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age ?18 years old 2. Subjects must have signed informed consent indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of ? 2 4. Confirmed diagnosis of multiple myeloma (International Myeloma Working Group [IMWG] criteria requiring treatment 5. Subject is not a candidate for high dose chemotherapy with stem cell transplantation due to: a. Age ? 65 years, or b. In subjects 200 mg/24 hours 7. Have pretreatment clinical laboratory values meeting the protocol criteria within 14 days before treatment 8. Female subjects must be postmenopausal (at least 12 months since last menses), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control; Men must be sterilized or agree to use a double barrier method of birth control and must agree to not donate sperm during the study and for 6 months after the last administration of study agent. 9. Subjects must be able to adhere to study visit schedule and all protocol requirements. 10. The anticipated life expectancy is such that the subject will be able to participate for the duration of the study 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: 1. Diagnosis of primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS) 2. Diagnosis of Waldenström?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 3. Prior or current systemic therapy or stem cell transplantation for multiple myeloma (including, corticosteroids, clarithromycin, mAbs, immunotherapy, investigative therapy, or immunosuppressive therapy) with the exception of emergency use of a short course (maximum 4 days) of corticosteroids before treatment 4. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 5. Radiation therapy within 14 days before treatment 6. Plasmapheresis within 14 days before treatment 7. Major surgery within 14 days before treatment 8. Transplanted solid organ, with the exception of a > or = 3 months before treatment corneal transplant 9. History of allergic reaction or hypersensitivity to boron or mannitol, or known allergies or clinically significant reactions to murine, chimeric, or human proteins 10. Concurrent medical condition or disease 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 11. Serious concurrent illness or history of uncontrolled heart disease such as unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, or clinically significant rhythm or conduction abnormality 12. Prior or concomitant malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the subject has undergone potentially curative therapy and has no evidence of that disease for ? 5 years 13. Vaccinated with live, attenuated vaccines within 4 weeks of the first administration of CNTO 328 14. Known infection with HIV, known hepatitis C infection, or known to be hepatitis B surface antigen positive 15. Use of any investigational agents within 30 days or 5 half lives of treatment 16. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 of the trial: To assess the safety of CNTO 328 at a dose of 11 mg/kg every 3 weeks when administered in combination with VMP. Part 2 of the trial: To demonstrate improved efficacy, as assessed by complete response (CR) rate using the European Group for Blood and Marrow transplantation (EBMT) criteria, of CNTO 328 in combination with VMP compared with VMP.;Secondary Objective: Part 1 of the trial: To explore the efficay, pharmacokinetics, and pharmacodynamics of CNTO 328 in combination with VMP. Part 2 of the trial: To assess additional measures of clinical benefit, safety, pharmacokinetics, and pharmacodynamics of CNTO 328 in combination with VMP.;Primary end point(s): Safety for Part 1 and CR rate, based on the EBMT criteria for Part 2 | — |
Countries
France, Italy, Spain
Outcome results
None listed