SHS_492304 BENW CBRI 15196

A Phase 2 Single Arm Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone (EPd) in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide

This is a Phase 2, multi-center, open-label, single arm study of elotuzumab in combination with pomalidomide and low dose dexamethasone to assess the safety and efficacy of this combination therapy for treatment of MM patients who have relapsed after or are refractory to a prior treatment with a lenalidomide-based regimen. Seventy-two subjects will be screened and a minimum of 60 subjects will be enrolled and treated by the combination. The estimated duration of enrollment is 18 to 24 months, minimum of 24 months follow-up and study duration of about 48 months.

Inclusion Criteria:

•Documented relapsed or refractory multiple myeloma to a prior lenalidomide based regimen defined as:
Relapse: progressive disease ≤ 6 months after achieving partial response
Refractory: progressive disease on treatment or within 60 days of last therapeutic dose (Note: Lenalidomide based regimen to which the subject has relapsed or been refractory to, is not required to be the most recent regimen received)
•Subjects must have received prior 1 or 2 lines of treatment that should have included at least 2 consecutive cycles of lenalidomide (full therapeutic dose)
•Measurable disease at screening, based on central laboratory results, defined as one or more of the following:
•Serum IgG, IgA, IgM M-protein ≥0.5 g/dL
•Urine M-Protein ≥ 200 mg urinary M-protein excretion in a 24 hour collection sample
•Involved serum free light chain (sFLC) ≥ 10 mg/dL provided the FLC ratio is abnormal
•ECOG performance status ≤ 2

Exclusion Criteria:

•Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
•Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
•Subjects with active plasma cell leukemia (defined as either 20% of peripheral blood white blood cell count comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 10^9/L)
•Subjects with Central Nervous System involvement with multiple myeloma
Phase II
John Pagel, M.D.
BMS (Bristol-Myers Squibb)
Tenzin Tsomo
  • Swedish Medical Center