A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma
Condition: High-risk Smoldering Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Intervention: Siltuximab; Placebo
Intervention description: Type=exact, unit=mg/kg, number=15, form=intravenous infusion, route=intravenous use, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.; Form=intravenous infusion, route=intravenous use route=intravenous, use every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.
Intervention MeSH terms: Siltuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: High-risk smoldering multiple myeloma; Multiple myeloma; Siltuximab

Summary:

      The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with
      placebo (an inactive substance that is compared with a drug to test whether the drug has a
      real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma
      (SMM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of smoldering multiple myeloma (SMM) for <4 years

          -  Diagnosis of high-risk SMM (defined as bone marrow plasma cells >=10% and either serum
             monoclonal protein >=3 g/dL, or abnormal free light chain ratio <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

        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