High-risk Smoldering Multiple Myeloma MedDRA version: 17.1 Level: LLT Classification code 10028233 Term: Multiple myeloma without mention of remission System Organ Class: 100000004864
Conditions
Interventions
Product Name: Siltuximab
Product Code: CNTO 328
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Siltuximab
Current Sponsor code: CNTO328
Other descriptive name: Chimeric mur
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of smoldering multiple myeloma (SMM) for =10%) and Serum M-protein >=3 g/dL or Abnormal FLC ration (8) and serum M-protein =65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: - Having symptomatic multiple myeloma, defined by any of the following (if due to myeloma): lytic bone lesions, severe osteopenia (low bone density), pathologic fractures, hypercalcemia (too much calcium in the blood), kidney insufficiency; symptomatic hyperviscosity of the blood, or recurrent serious bacterial infections such as pneumonia. - Primary systemic amyloid light (AL) chain amyloidosis (a build-up of amyloid light chain proteins in the blood). - Prior or concurrent exposure to approved or investigational multiple myeloma treatments (concurrent treatment with bone-protecting agents (eg, bisphosphonates, denosumab), or steroids (not exceeding 10 mg prednisone per day or equivalent) are only allowed if given in a stable dose and for a nonmalignant condition. Concurrent treatment with erythropoietin-stimulating agents (ESAs) are not allowed.). - Prior exposure to agents targeting interleukin 6 (IL 6) or the IL 6 receptor. - Other malignancy within the past 3 years, except for the following, if treated and not active: basal cell or nonmetastatic (non-spreading) squamous cell carcinoma of the skin, cervical carcinoma or International Federation of Gynecology and Obstetrics Stage 1 carcinoma of the cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that siltuximab will delay progression of high-risk SMM as measured by the 1 year progression-free survival (PFS) rate.;Secondary Objective: The secondary objectives of the study are to evaluate additional efficacy measurements including PFS and patient-reported symptoms (patient-reported outcomes [PROs]), as well as safety, pharmacokinetics, antibodies to siltuximab (immunogenicity), and potential biomarkers predictive of response to siltuximab treatment and progression to symptomatic multiple myeloma. Upon progression to multiple myeloma, cytogenetics and response to first subsequent multiple myeloma treatment will be characterized. During an interim analysis, the 6 month progressive disease indicator rate and other endpoints will be evaluated.;Primary end point(s): One-year progression-free survival rate (PFS) ;Timepoint(s) of evaluation of this end point: 6 months after 74th participant is randomized | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Progression-free survivial (PFS) 2. Progressive Disease (PD) indicator rate 3. European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ C30) 4. Brief Pain Inventory (worst pain item) 5. Changes in Clinical laboratory values 6. Number of participants experiencing adverse events 7. Overall survival;Timepoint(s) of evaluation of this end point: 1, 3, 4, 5,6 Up to approximately 4 years after randomization of last patient 2 6 months after 74th participant is randomized 7. Approximately 4 years after randomization of last patient | — |
Countries
Australia, Belgium, France, Germany, Greece, Israel, Korea, Republic of, Spain, Sweden, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International N.V.
Outcome results
None listed