Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma

Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Age Range:18 - 75
Start Date:November 22, 2017
End Date:February 28, 2026
Contact:Ravi Vij, M.D.
Phone:(314) 454-8323

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A Phase II Study of Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma

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.

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.

- Refractory to or intolerant of lenalidomide maintenance following first autologous
stem cell transplantation. Refractory is defined as disease relapse/progression on
therapy or within 60 days of completing therapy. Intolerance is defined as the
inability to administer ≥ 10 mg per day due to toxicity.

- 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
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 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)


- 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:

- Prior exposure to elotuzumab or pomalidomide.

- Received systemic multiple myeloma therapy post-relapse/progression. Patients that
received 1-2 cycles of salvage therapy, local radiation, and/or corticosteroids
post-relapse/progression are eligible if there was no further disease progression
following administration.

- 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.
We found this trial at
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Ravi Vij, M.D.
Phone: 314-454-8323
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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