Elotuzumab, Pomalidomide, and Dexamethasone in Treating Patients with Relapsed of Refractory Multiple Myeloma Undergoing Second Stem Cell Transplant

Inclusion Criteria

• Histologically confirmed diagnosis of multiple myeloma
• Received prior autologous stem cell transplantation as first line therapy for multiple myeloma with subsequent disease relapse/progression
• Failed 1 or 2 prior lines of treatment for multiple myeloma; a line of treatment includes all therapy including induction, transplant, and maintenance administered in a sequence in the absence of relapse/progression; once relapse/progression occurs and subsequently the anti-myeloma treatment is changed, a new line of treatment has begun; local radiation or corticosteroids will not be considered treatment for multiple myeloma
• Received 2 to 6 cycles of induction therapy per standard of care prior to 2nd autologous stem cell transplantation
• Received standard of care melphalan conditioning for 2nd autologous stem cell transplantation, is currently day +80 to +120 following transplant, and is responding to therapy (partial response or better as compared to pre-induction assessment)
• All United States (US) study participants must be registered into the mandatory pomalidomide (POMALYST) Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of the POMALYST REMS program; for Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
• Females of reproductive potential within the US must agree to adhere to the scheduled pregnancy testing as required in the POMALYST REMS program; for Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
• Candidate for second autologous stem cell transplantation per local institution’s guidelines with at least 2 x 10^6/kg CD34+ autologous stem cells available for transplantation
• At least 18 and no more than 75 years of age at enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Absolute neutrophil count >= 1000/mm^3
• Platelets >= 75,000/mm^3 (transfusions not permitted within 7 days of screening)
• Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3.0 x IULN
• Creatinine clearance >= 15 mL/min
• Females of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry through day +100 visit; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
• Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document

Exclusion Criteria

• Refractory to elotuzumab and/or pomalidomide, defined as progressive disease or clinical relapse on therapy or within 60 days following completion of therapy. Prior exposure to elotuzumab or pomalidomide is allowed as long as patient is not refractory to these agents
• More than one prior transplant prior to study entry with the exception of tandem transplantation; tandem transplantation is defined as two autologous stem cell transplants that occur within 9 months of one another, and the patient did not have disease progression in the period between the two transplants
• Presence of peripheral neuropathy >= grade 3 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v 4.0)
• History of plasma cell leukemia or multiple myeloma (MM) central nervous system (CNS) involvement
• Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis
• Diagnosed with another concurrent malignancy requiring treatment
• Known human immunodeficiency virus (HIV) or active hepatitis A, B, or C; antibody testing not required for screening
• Known hypersensitivity to pomalidomide, dexamethasone, or any excipients in elotuzumab, formulation, or recombinant protein
• Receiving any other investigational agents within 14 days prior to enrollment
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• Pregnant and/or breastfeeding; females of childbearing potential must have two negative pregnancy tests; the first test should be performed within 10-14 days of study entry, and the second test within 24 hours prior to prescribing pomalidomide