Health Condition 1: null- Multiple Myeloma
Conditions
Interventions
Intervention1: Siltuximab (CNTO328): Siltuximab (CNTO328) + VMP (Arm A) CNTO328 11 mg/kg and VMP in 9 cycles of 42 days each
Control Intervention1: Velcade Melphalan Prednisone: VMP Alone (Arm B). VMP
Sponsors
Janssen Research Development LLC
Johnson Johnson Limite
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for high dose chemotherapy with stem cell transplantation Eastern cooperative oncology group performance status score of less than or equal to 2 Measurable secretory disease, defined as either serum monoclonal paraprotein greater than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours - Adequate laboratory results that will be confirmed by a study physician - Agrees to protocol-defined use of effective contraception.
Exclusion criteria
Exclusion criteria: 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 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 (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 (&#8805; 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 &#8805; 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Part 1 To asses additional measures of clinical benefit, pharamacokinetics, pharmacodynamics of CNTO 328 in combination with VMP in Part 2 To assess additional measurements of clinical benefit, safety, pharmacokinetics and biomarkers of CNTO328 in combination with VMP.Timepoint: Time Frame: 54 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Rate of Complete Response per European Bone Marrow Transplant (EBMT) CriteriaTimepoint: Time Frame: 42 days; 54 weeks | — |
Countries
Australia, France, India, Israel, Italy, Poland, Romania, Russian Federation, Singapore, Spain, Ukraine, United States of America
Contacts
Public ContactDr Jitendra Dixit
Outcome results
None listed