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

Phase 2CompletedNCT02159365

Bristol-Myers Squibb84 enrolled

Overview

To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

ElotuzumabDRUG

LenalidomideDRUG

DexamethasoneDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (29)

Outcomes

Primary Outcomes

Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2

Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.

Time frame: From Day 1 to End of cycle 2 treatment (approximately 56 days)

Secondary Outcomes

Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period

An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.

Time frame: Date of first dose up to 60 days post last dose (approximately 4 years)

Data from ClinicalTrials.gov

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