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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is to determine the safety and tolerability of elotuzumab administered in combination with thalidomide and dexamethasone in the treatment of relapsed and/or refractory multiple myeloma.

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Detailed Description

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Conditions

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Relapsed and/or Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide

Group Type EXPERIMENTAL

Elotuzumab

Intervention Type BIOLOGICAL

Powder for solution, 400-mg vials, for infusion

Thalidomide

Intervention Type BIOLOGICAL

50-mg capsules administered orally

Dexamethasone

Intervention Type BIOLOGICAL

2- and 4-mg tablets (and various other strengths, as needed) administered orally and in 4- and 8-mg/mL (and various other strengths, as needed) solutions for intravenous administration

Cyclophosphamide

Intervention Type BIOLOGICAL

50-mg tablets administered orally

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Inclusion Criteria

* Confirmed diagnosis of previously treated multiple myeloma with progression documented by criteria of the International Myeloma Working Group after or during the most recent therapy
* Patient received 5 or fewer prior lines of therapy
* Eastern Cooperative Oncology Group performance status of 0 or 1 (safety lead-in cohort) or 0 to 2 (additional patients)
* Measurable disease as defined by at least 1 of the following:

* Serum immunoglobulin (Ig)G, IgA, IgM, or monoclonal (M) protein level ≥0.5 g/dL or serum IgD M protein level ≥0.05 g/dL; or
* Urine M protein level ≥200 mg excreted in a 24-hour collection sample; or
* 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, smoldering myeloma, or Waldenström's macroglobulinemia
* Left ventricular ejection fraction by echocardiogram or Multi Gated Acquisition ≤50%
* Electrocardiogram finding of QTc ≥450 msec
* Active plasma cell leukemia (defined as either 20% of peripheral white blood cells, composed of plasma/CD138+ cells or an absolute plasma cell count of 2\*10\^9/L)
* Diagnosis of nonsecretory myeloma
* Active hepatitis A, B, or C virus infection
* Grade ≥2 neuropathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No