Clinical trial NCT02159365: Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
Official title: A Phase 2 Single Arm Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 84
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: To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.


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

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Documented evidence of active multiple myeloma:

  * Newly diagnosed, not candidate for transplant
  * Relapsed/refractory who have received up to 3 prior lines of therapy
* Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:

  * Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide
  * Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)

Exclusion Criteria:

* Target Disease Exceptions

  * Plasma cell leukemia
  * Monoclonal gammopathy of undetermined significance (MGUS)
  * Smoldering Myeloma
* Primary amyloidosis
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome

Primary outcomes:
measure: Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
timeFrame: From Day 1 to End of cycle 2 treatment (approximately 56 days)
Secondary outcomes:
measure: Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
timeFrame: Date of first dose up to 60 days post last dose (approximately 4 years)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Acrc/Arizona Clinical Research Center, Inc.
state: Arizona
city: Fayetteville
country: United States
facility: Highland Oncology Group
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood And Cancer Center
state: California
city: Encinitas
country: United States
facility: California Cancer Associates for Research and Excellence
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Res Grp
state: California
city: Fountain Valley
country: United States
facility: Robert A. Moss, Md Facp, Inc.
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: West Hills
country: United States
facility: Wellness Oncology & Hematology
state: California
city: West Hollywood
country: United States
facility: James R. Berenson, MD, Inc.
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers Llp
state: Colorado
city: Jacksonville
country: United States
facility: Cancer Specialists Of North Florida
state: Florida
city: Lakeland
country: United States
facility: Center For Cancer Care & Research
state: Florida
city: Miami
country: United States
facility: Baptist Health Medical Group Oncology
state: Florida
city: Park Ridge
country: United States
facility: Oncology Specialists,S.C
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research Of Indiana, Llc
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc
state: Indiana
city: New York
country: United States
facility: Clinical Research Alliance, Inc.
state: New York
city: Greenville
country: United States
facility: St Francis Hospital
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: Cancer Centers of South Texas
state: Texas
city: Tyler
country: United States
facility: Blood & Cancer Center of East Texas
state: Texas
city: Weslaco
country: United States
facility: Texas Oncology-McAllen South Second Street
state: Texas
city: Blacksburg
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Olympia
country: United States
facility: Vista Oncology Inc., PS
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: