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Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsed and/or Refractory Multiple Myeloma

Intervention: Elotuzumab (Biological); Thalidomide (Biological); Thalidomide (Biological); Thalidomide (Biological); Dexamethasone (Biological); Dexamethasone (Biological); Dexamethasone (Biological); Cyclophosphamide (Biological)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose of this study is to determine how safe and well tolerated Elotuzumab is in combination with Thalidomide and Dexamethasone when treating patients with relapsed and/or refractory Multiple Myeloma (MM).

Clinical Details

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

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

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

Secondary outcome: Proportion of subjects who experience one or more dose reductions or discontinuation of study treatment due to drug related adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com. Inclusion Criteria:

- Confirmed diagnosis of previously treated multiple myeloma with documented

progression International Myeloma Working Group (IMWG) criteria after or during the most recent therapy

- Patient received 5 or less prior lines of 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 immunoglobulin G (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

- LVEF by echocardiogram or Multi Gated Acquisition (MUGA) must not be ≤50%

- Electrocardiogram (ECG) QTc ≥450 msec will be excluded

- 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

Locations and Contacts

Local Institution, Barcelona 08916, Spain

Local Institution, Barcelona 08036, Spain

Local Institution, Barcelona 08041, Spain

Local Institution, Barcelona 08035, Spain

Local Institution, LaLaguna, S Cruz Tener 38320, Spain

Local Institution, Madrid 28034, Spain

Local Institution, Madrid 28041, Spain

Local Institution, Salamanca 37007, Spain

Local Institution, Sevilla 41013, Spain

Local Institution, Zaragoza 50009, Spain

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: May 2012
Last updated: August 19, 2015

Page last updated: August 23, 2015

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