Clinical trial NCT01632150: Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed and/or Refractory Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2012-07-02
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Key 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

Key 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

Primary outcomes:
measure: Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
timeFrame: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
measure: Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
timeFrame: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
Secondary outcomes:
measure: Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
timeFrame: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
measure: Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
timeFrame: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: LaLaguna, S Cruz Tener
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Zaragoza
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: