NCT02159365 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2019-07-16

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

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

→

outcome · POSTED

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

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
intervention Names
Drug: Elotuzumab
Drug: Lenalidomide
Drug: Dexamethasone
label
Elotuzumab + Lenalidomide/Dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
Elotuzumab + Lenalidomide/Dexamethasone
name
Elotuzumab
other Names
BMS-901608
type
DRUG
arm Group Labels
Elotuzumab + Lenalidomide/Dexamethasone
name
Lenalidomide
other Names
Revlimid
type
DRUG
arm Group Labels
Elotuzumab + Lenalidomide/Dexamethasone
name
Dexamethasone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 84
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
time Frame
From Day 1 to End of cycle 2 treatment (approximately 56 days)

secondary Outcomes

description
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.
measure
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
time Frame
Date of first dose up to 60 days post last dose (approximately 4 years)

Full study description

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

Source references