A Randomized, Open label, Phase 2 Study of CNTO 328 (Anti IL 6 Monoclonal Antibody) and VELCADE Melphalan Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma - ND

• Conditions: Previously Untreated symptomatic Multiple Myeloma; MedDRA version: 12.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2008-007157-12-IT
• Lead Sponsor: CENTOCOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-28
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

To be eligible for the study, subjects must meet all of the following criteria: 1. Male or female = 18 years of age at screening 2. Subjects (or their legally acceptable representatives) 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. Informed consent must be obtained before performing any study-specific procedures. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of = 2 (see Appendix B) 4. Confirmed diagnosis of multiple myeloma (International Myeloma Working Group [IMWG] criteria; see Appendix A) 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 < 65 years: presence of important comorbid condition(s) likely to have a negative impact on the tolerability of high-dose chemotherapy with stem cell transplantation. Sponsor review of these comorbid conditions and approval is required before randomization (refer to the Trial Center File for details). 6. Measurable secretory disease, defined as either serum monoclonal paraprotein (M-protein) = 1 g/dL or urine monoclonal (light chain) protein > 200 mg/24 hours 7. Have pretreatment clinical laboratory values meeting the following criteria within 14 days before treatment: a. Hemoglobin = 8 g/dL (= 4.96 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted) b. Absolute neutrophil count (ANC) = 1.0 x 109/L c. AST = 2.5 x ULN d. ALT = 2.5 x ULN e. Total bilirubin =1.5 x ULN, except in subjects with congenital bilirubinemia, such as Gilbert syndrome f. Calculated creatinine clearance = 20 mL/min g. Corrected serum calcium < 14 mg/dL (< 3.5 mmol/L); see Section 8.3.1.5 for formula) or free ionized calcium < 6.5 mg/dL (< 1.6 mmol/L) h. Platelet count = 70 x 109/L 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 (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before study entry, for the duration of study participation, and for 6 months after the last administration of study agent, and must have a negative urine pregnancy test within 1 week before beginning treatment. 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

Subjects meeting any of the following criteria may not be enrolled in the study: 1. Diagnosis of primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS). Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of related organ or tissue impairment (ROTI) end-organ damage (Kyle, 2003). MGUS is defined by presence of serum M-protein < 3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less (Kyle, 2003). 2. Diagnosis of Waldenstr?m 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 (NCI-CTCAE), Version 3.0 5. Radiation therapy within 14 days before treatment 6. Plasmapheresis within 14 days before treatment 7. Major surgery within 14 days before treatment (Kyphoplasty is not considered major surgery) 8. Transplanted solid organ, with the exception of a corneal transplant (= 3 months before treatment) 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 (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary 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 (other than multiple myeloma) 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 (whichever is longer) of treatment 16. Pregnant or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified