- 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 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
- 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 US study participants must be registered into the mandatory POMALYST 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
- 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
- At least 18 and no more than 75 years of age at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Normal bone marrow and organ function as defined as ALL of the following:
- 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)
- AST(SGOT)/ALT(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.
- 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 and/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 (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
- History of plasma cell leukemia or MM central nervous system (CNS) involvement.
- Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Diagnosed with another concurrent malignancy requiring treatment.
- Known HIV or active hepatitis A, B, or C. Antidoby 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
- 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.