Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
Inclusion Criteria:
- Confirmed diagnosis of previously treated multiple myeloma with documented
progression by International Myeloma Working Group (IMWG) criteria after/during most
recent therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (safety lead-in
cohort) or 0-2 (additional subjects)
- Measurable disease as defined by at least one of the following;
1. Serum IgG, IgA, IgM M-protein ≥ 0.5 g/dL, or serum IgD M-protein ≥ 0.05 g/dL; OR
2. Urine M protein ≥ 200 mg excreted in a 24-hour collection sample; OR
3. Involved serum free light chain level ≥ 10 mg/dL provided the free light chain
ratio is abnormal
Exclusion Criteria:
- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
cell dyscrasia
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma or
Waldenström's macroglobulinemia
- Active plasma cell leukemia (defined as either 20% of peripheral White Blood Cells
(WBC) comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L
to 2 x 100,000,0000/L)
- Subjects with non-secretory myeloma
- Active hepatitis A, B, or C
- Grade ≥2 neuropathy