SLAMF7 Fresh Peripheral Blood Mononuclear Cells for the Treatment of Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

• Must have received at least 2 consecutive cycles of treatment containing an immunomodulatory drug (IMiD), a proteasome inhibitor, and anti-CD38 monoclonal antibody, either used individually or in combination
• Documented refractory or relapsed myeloma * Refractory is defined as progression while on treatment or within 60 days of last treatment
• Measurable disease based on at least one of the following lab results within 28 days of enrollment * Serum IgG, IgA, or IgM M-protein >= 1.0 g/dL * Urine M-protein >= 200 mg excreted in a 24-hour (hr) collection sample * Involved serum free light chain (FLC) >= 100 mg/L provided the FLC ratio is abnormal
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Left ventricular ejection fraction (LVEF) >= 45% at rest (MUGA or echocardiogram)
• Age >= 18 years at the time of consent (Written informed consent and Health Insurance Portability and Accountability Act [HIPAA] authorization for release of personal health information)
• Females of childbearing potential, and males, must be willing to use an effective method of contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover)
• Adequate cardiac function as defined as: * No electrocardiography (EKG) evidence of acute ischemia * No EKG evidence of clinically significant conduction system abnormalities in the opinion of the treating investigator * No EKG evidence of > grade 2 (> 480 ms) corrected QT interval (QTc) prolongation * No uncontrolled angina or severe ventricular arrhythmias * No clinically significant pericardial disease * No history of myocardial infarction (MI) in the last 6 months * No class 3 or higher New York Heart Association congestive heart failure
• Absolute lymphocyte count >= 400/mm^3 (performed within 14 days prior to enrollment)
• Absolute neutrophil count (ANC) >= 1,000/mm^3 (performed within 14 days prior to enrollment)
• Platelets >= 75,000/mm^3 (performed within 14 days prior to enrollment)
• Calculated creatinine clearance >= 30 ml/min (performed within 14 days prior to enrollment) * Creatinine clearance should be calculated per institutional standard
• Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (performed within 14 days prior to enrollment)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 times normal (performed within 14 days prior to enrollment)

Exclusion Criteria

• Known hypersensitivity to elotuzumab (Elo)
• Amyloidosis, Waldenstrom’s macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin (POEMS) syndrome, or known central nervous system (CNS) involvement
• Receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment * NOTE: Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Active autoimmune disease that has required systemic treatment in the past 2 years before enrollment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
• Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment
• Active liver disease (such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis)
• Human immunodeficiency virus (HIV) positive or known active hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) or hepatitis B (e.g. hepatitis B virus surface protein antigen [HBsAg] reactive) virus
• Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
• Has an active infection requiring systemic therapy
• History of active TB (bacillus tuberculosis)
• Has received a live vaccine within 30 days of enrollment
• Anti-myeloma drug therapy (including radiation therapy) =< 14 days prior to apheresis
• History of myocardial infarction (within 6 months of enrollment), stable or unstable angina
• History of another malignancy within the past 3 years before enrollment. Exceptions include: * Basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ cancers that have undergone potentially curative therapy
• Prisoners or patients who are incarcerated
• Patients who are compulsorily detained for treatment of either a psychiatric or physical illness
• Pregnant or breastfeeding females: Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment