Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Recurrence
Intervention: Elotuzumab; Lenalidomide; Dexamethasone
Intervention description: Elotuzumab according to dosing schedule outlined in treatment arms.; Lenalidomide according to dosing schedule outlined in treatment arms.; Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
Intervention MeSH terms: Thalidomide; Dexamethasone; Lenalidomide; Elotuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lenalidomide maintenance; hematopoietic cell transplantation; serologic relapse

Summary:

      The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide
      when elotuzumab is added to multiple myeloma participants with serologic relapse/progression
      while receiving lenalidomide maintenance for each study arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with multiple myeloma who demonstrate evidence of serologic
             relapse/progression while on lenalidomide maintenance given as part of first line
             therapy (including upfront high-dose chemotherapy followed by autologous hematopoietic
             cell transplantation (HCT)) without symptomatic relapse/progression. Lenalidomide
             maintenance is defined as single agent lenalidomide therapy of any doses up to 10 mg
             PO 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 the
             study 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 Working
             Group (IMWG) Uniform Response Criteria for Multiple Myeloma defined as one or more of
             the following criteria:

               -  Development of new soft tissue plasmacytomas or bone lesions (osteoporotic
                  fractures do not constitute progression)

               -  Definite increase in the size of existing plasmacytomas or bone lesions. A
                  definite increase is defined as a 50% (and ≥1 cm) increase as measured serially
                  of the measurable lesion

               -  Hypercalcemia (>11 mg/dL);

               -  Decrease in hemoglobin of ≥2 g/dL not related to therapy or other
                  non-myeloma-related conditions;

               -  Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and
                  attributable 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 must
             have a negative serum pregnancy testing within 7 days prior to the administration of
             drug.

          -  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 or
             squamous 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)