Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for
multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT,
the natural next step is to evaluate maintenance/continuation therapy following second ASCT.
Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide,
making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab
may increase efficacy and also the durability of responses which is essential to improving
outcomes following second ASCT.
- Histologically confirmed diagnosis of multiple myeloma.
- Received prior autologous stem cell transplantation as first line therapy for multiple
myeloma with subsequent disease relapse/progression.
- Currently undergoing 2nd or 3rd line 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. Patients may have received 1-2 cycles of salvage
therapy, local radiation, and/or corticosteroids as part of 2nd or 3rd line treatment
prior to study entry if there was no further disease progression following
- 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
- Candidate for second autologous stem cell transplantation per local institution's
guidelines with at least 2x106/kg CD34+ autologous stem cells available for
- 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.
- Prior exposure to elotuzumab or pomalidomide.
- 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.