Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide

Inclusion Criteria:

• Patients with multiple myeloma who demonstrate evidence of serologicrelapse/progression while on lenalidomide maintenance given as part of first linetherapy (including upfront high-dose chemotherapy followed by autologous hematopoieticcell transplantation (HCT)) without symptomatic relapse/progression. Lenalidomidemaintenance is defined as single agent lenalidomide therapy of any doses up to 10 mgPO daily for up to 28 days (28-day cycle).
• Male or female patients aged ≥ 18 years old
• Ability to provide written informed consent obtained prior to participation in thestudy and any related procedures being performed
• Measurable disease as outlined in protocol guidelines
• Participants must meet laboratory criteria as outlined in protocol guidelines

Exclusion Criteria:

• Prior Elotuzumab
• Patients with clinical relapse/progression as per the International Myeloma WorkingGroup (IMWG) Uniform Response Criteria for Multiple Myeloma defined as one or more ofthe following criteria:
• Development of new soft tissue plasmacytomas or bone lesions (osteoporoticfractures do not constitute progression)
• Definite increase in the size of existing plasmacytomas or bone lesions. Adefinite increase is defined as a 50% (and ≥1 cm) increase as measured seriallyof the measurable lesion
• Hypercalcemia (>11 mg/dL);
• Decrease in hemoglobin of ≥2 g/dL not related to therapy or othernon-myeloma-related conditions;
• Rise in serum creatinine by 2 mg/dL or more from the start of the therapy andattributable to myeloma
• Hyperviscosity related to serum paraprotein
• Women who are pregnant or breast feeding or women of childbearing potential (WOCBP)not using an effective method of birth control. Women of childbearing potential musthave a negative serum pregnancy testing within 7 days prior to the administration ofdrug.
• Male patients whose sexual partners are WOCBP not using effective birth control
• Patients with a prior malignancy with in the last 5 years (except for basal orsquamous cell carcinoma, or in situ cancer of the cervix)
• Patients with known positivity for human immunodeficiency virus (HIV)) or hepatitis C;baseline testing for HIV and hepatitis C is not required
• Patients with a diagnosis of POEMS syndrome (polyneuropathy, organomegaly,endocrinopathy, monoclonal protein, and skin changes) or plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)