The goal of this clinical research study is to find the highest tolerable dose of Siltuximab that can be given in combination with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone to patients with MM. The safety of this drug combination will also be studied.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 1\. Multiple Myeloma Diagnosis: Subject was previously diagnosed with multiple myeloma by the International Myeloma Foundation 2003 Diagnostic Criteria: IMF Diagnostic Criteria: DIAGNOSTIC CRITERIA: ALL 3 REQUIRED 1. Monoclonal plasma cells in the bone marrow \> 10% and/or presence of a biopsy-proven plasmacytoma 2. Monoclonal protein present in the serum and/or urine \* 3. Myeloma-related organ dysfunction (1 or more) \*\* ; \[C\] Calcium elevation in the blood S. Calcium \>10.5 mg/l or upper limit of normal ; \[R\] Renal insufficiency ; \[A\] Anemia Hemoglobin \< 10 g/dl or 2 g \< normal ; \[B\] Lytic bone lesions or osteoporosis \*\*\*
✓. Continuation from Inclusion # 1: \*If no monoclonal protein is detected (non-secretory disease), then \> 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required \*\* A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification of myeloma if proven to be myeloma related. \*\*\* If a solitary (biopsy-proven) plasmacytoma or osteoporosis alone (without fractures) are the sole defining criteria, then \> 30% plasma cells are required in the bone marrow.
✓. Patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma. Prior treatment of hypercalcemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period). Bisphosphonates are permitted
✓. Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible. One week must have lapsed since last date of radiotherapy, which is recommended to be a limited field. Patients who require concurrent radiotherapy should have start of the protocol therapy (Cycle 1 Day 1) deferred until the radiotherapy is completed and one week have passed since the last date of therapy.
✓. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
✓. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL 10 - 14 days prior to therapy and repeated again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
✓. Age \>/= 18 years at the time of signing Informed Consent.
✓. All necessary baseline studies for determining eligibility must be obtained within 28 days prior to enrollment.
Exclusion criteria
✕. Patient has \>/=Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment.
✕. Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count \>/= 50,000 cells/mm\^3).
✕. Subjects with an absolute neutrophil count (ANC) \< 1000 cells/mm\^3. Growth factors may not be used to meet ANC eligibility criteria.
✕. Total bilirubin \> 1.5 mg/dL
✕. Subjects with a hemoglobin \< 8.0 g/dL (Transfusion are permitted).
✕. AST (SGOT and ALT (SGPT) \>/= 2 x upper limit of normal (ULN)
✕. Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.