A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients with High-risk Smoldering Multiple Myeloma
- Conditions
- High-risk Smoldering Multiple MyelomaMedDRA version: 19.0Level: LLTClassification code 10028233Term: Multiple myeloma without mention of remissionSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001735-22-DE
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 85
- 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 not of childbearing potential must be postmenopausal, permanently sterilized, or otherwise incapable of pregnancy
- Women of childbearing potential must agree to use adequate birth control measures and agree to not donate eggs for the purpose of assisted reproduction 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 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
- 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.
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: 6 months after 74th participant is randomized
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Progression-free survivial (PFS)<br>2. Progressive Disease (PD) indicator rate<br>3. European Organization for Research and Treatment of Cancer, Quality<br>of Life Questionnaire-Core 30 (EORTC QLQ C30)<br>4. Brief Pain Inventory (worst pain item)<br>5. Changes in Clinical laboratory values<br>6. Number of participants experiencing adverse events<br>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<br>patient<br>2 6 months after 74th participant is randomized<br>7. Approximately 4 years after randomization of last patient