A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients with High-risk Smoldering Multiple Myeloma
- Conditions
- High-risk Smoldering Multiple MyelomaMedDRA version: 14.1 Level: LLT Classification code 10028233 Term: Multiple myeloma without mention of remission System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001735-22-SE
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
- Diagnosis of smoldering multiple myeloma (SMM) for <4 years and a diagnosis of high-risk SMM ( Bone marrow plasma cells >=10%) and Serum M-protein >=3 g/dL or Abnormal FLC ration (<0.126 or >8) and serum M-protein < 3 g/dL but ? 1 g/dL.
- Patients must be within certain limits for protocol-specified laboratory tests.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Women of childbearing potential must agree to use adequate birth control measures during the study and for 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening.
- Men must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study agent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. 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
2. Primary systemic AL amyloidosis (a build-up of amyloid light chain proteins in the blood)
3. Prior or concurrent exposure to approved or investigational multiple myeloma treatments. Concurrent treatment with bone-protecting agents (eg, bisphosphonates, denosumab), or cortisteroids with a dose 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.
4. Prior exposure to agents targeting interleukin 6 (IL 6) or the IL 6 receptor
5. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: One year after randomization of last patient
- Secondary Outcome Measures
Name Time Method