Treatment Study for Patients with Multiple Myeloma
To provide pomalidomide/dexamethasone and/or elotuzumab treatment for patients with relapsed and refractory multiple myeloma and to collect additional data on treatment safety.
In order to participate you must meet the following criteria:
- Have ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination.
- Have a refractory that progressed on or within 60 days of their last treatment.
- Have a refractory to proteosome inhibitor and lenalidomide, and to last treatment.
- Are a relapsed and/or refractory patient who has achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment.
- Have measurable disease at screening.
- Are at least 18 years of age with ECOG performance status 0-2.
You will be excluded from the study if any of the following criteria apply to you:
- Have active plasma cell leukemia.
- Have solitary bone or extramedullary plasmacytoma as only evidence of plasma cell dyscrasia.
- Have prior exposure to pomalidomide.
- Have prior autologous stem cell transplant within 12 weeks.
- Have prior allogeneic stem cell transplant within 12 months. (No history of GVHD and are not receiving topical or systemic immunosuppressive therapy.)
- Are HIV positive or have active hepatitis A, B or C.
- Have uncontrolled or severe cardiovascular or pulmonary disease or active infection requiring parenteral anti-infective treatment >14 days.
- Have had major cardiac surgery within 8 weeks prior to study drug or other major surgery within 4 weeks.
- Have undergone treatment with melphalan or monoclonal antibodies within 6 weeks of first dose of study drug or treatment.
- Have undergone treatment with corticosteroids within 3 weeks of the first dose of study drug (except equivalent of < 10mg prednisone/day or steroids with minimal systemic absorption or for short course (< 4 days) of 40mg dexamethasone for emergency use.
This is a partial list of inclusion and exclusion criteria.