Should I visit Emory or WashU

Elotuzumab, pomalidomide and dexamethasone (Elo-Pom-Dex) with second autologous stem cell transplant for relapsed multiple myeloma

Eligibility to participate

Criteria:

Inclusion criteria: - Histologically confirmed diagnosis of multiple myeloma. - Previous autologous stem cell transplant as first-line therapy for multiple received myeloma with subsequent disease relapse / progression. - 1 or 2 lines of treatment for multiple myeloma failed. A line of treatment includes all therapies, including induction, transplant and maintenance, are performed in a sequence in the absence of relapse / progression. Once relapse / progression occurs and then the anti-myeloma treatment is changed, a new line of treatment has begun. Local radiation or corticosteroids are not considered a treatment for multiple myeloma. - Received 2 to 6 induction therapy cycles per treatment standard of autologous stem cell transplantation before the 2nd autologous stem cell transplantation - Received melphalan conditioning standard for the 2nd autologous stem cell transplantation, is currently +80 to +120 days after the transplantation and reacts to therapy (partial response or better in comparison for pre-induction assessment. - All US study participants must be enrolled in the mandatory POMALYST REMS® program and be willing and able to meet the requirements of the POMALYST REMS® program. Pregnancy Observed Prevention Program - Women with reproductive potential in the US must agree to adhere to the schedule of pregnancy tests under the POMALYST REMS® program. For Canadian sites, patients are followed up under the Pomalidomide Pregnancy Prevention Program - A minimum of 18 years and a maximum of 75 years at E inscription. - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Normal bone marrow and organ function as defined by ALL of the following: - Absolute neutrophil count ≥ 1000 / mm ^ 3 - Platelets ≥ 75,000 / mm ^ 3 (transfusions within 7 days of screening not permitted) - total bilirubin ≤ 2.0 x institutional upper limit of normal value (IULN) - AST (SGOT) / ALT (SGPT) ≤ 3.0 x IULN - creatinine clearance ≥ 15 ml / min - women of childbearing age and men must agree to adequate contraception (hormonal or barrier method of contraception, abstinence) before the start of the study by day +100 visit. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately. - Can understand an approved Institutional Review Board (IRB) and is willing to sign a written informed consent. Exclusion criteria: - Refractory to elotuzumab and / or pomalidomide, defined as progressive disease or clinical relapse after therapy or within 60 days of completing therapy.Exposure to elotuzumab and / or pomalidomide is permitted as long as the patient does not refractory to these agents . - More than one previous transplant before the start of the study with the exception of the tandem transplant. Tandem transplant is defined as two autologous stem cell transplants that occur within 9 months of each other and that the patient did not have disease progression between the two transplants. - Presence of ≥ Grade 3 peripheral neuropathy based on National Cancer Institute (NCI) General Adverse Event Terminology Criteria (CTCAE) v 4.0 - History of plasma cell leukemia or MM central nervous system (CNS) involvement. - Receiving kidney replacement therapy, hemodialysis, or peritoneal dialysis. - Diagnosis of another concurrent malignancy that needs treatment. - Known HIV or active hepatitis A, B or C. Antidoby tests are not required for screening - Known hypersensitivity to pomalidomide, dexamethasone or other excipients in elotuzumab, formulation or recombinant protein - Receipt of other investigative agents within 14 days prior the registration. - Uncontrolled intercurrent illness including, but not limited to, persistent or active infection, symptomatic heart failure, unstable angina or cardiac arrhythmia. - Pregnant and / or breastfeeding. Women 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. .

Gender:

All

Minimum age:

18 years

Maximum age:

75 years

Healthy volunteers:

No