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Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Relapsed and/or Refractory Multiple Myeloma

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Trial Information

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects who experience one or more severe (Grade 3 or higher) non-hematologic adverse events

Outcome Time Frame:

Up to 60 days after the last dose

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Spain: Spanish Agency of Medicines

Study ID:

CA204-010

NCT ID:

NCT01632150

Start Date:

June 2012

Completion Date:

April 2015

Related Keywords:

  • Relapsed and/or Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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