Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02279394 · OUTCOME

Objective Response Percent

E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma · Source last updated 2023-06-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
2 Years from start of treatment

What was measured

Percent of patients with objective response defined as partial response or better based on the International Myeloma Working Group Response (IMWG) criteria

Groups in this outcome

Elo / Len / Dex

•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID •Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8 Other Name: Decadron Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24 Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8

Elo / Len

•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Elo / Len / Dex40
Elo / Len11

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Elo / Len / Dex82.5Not reported69.691.5Not reported
Elo / Len72.7Not reported43.692.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.6
        upper Limit
        91.5
        value
        82.5
      2. group Id
        OG001
        lower Limit
        43.6
        upper Limit
        92.1
        value
        72.7
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Percent of patients with objective response defined as partial response or better based on the International Myeloma Working Group Response (IMWG) criteria
dispersion Type
90% Confidence Interval
groups
  1. description
    •Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID •Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8 Other Name: Decadron Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24 Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
    id
    OG000
    title
    Elo / Len / Dex
  2. description
    •Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
    id
    OG001
    title
    Elo / Len
param Type
NUMBER
reporting Status
POSTED
time Frame
2 Years from start of treatment
title
Objective Response Percent
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice