Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01572480 · OUTCOME

Percentage of Participants With Minimal Residual Disease (MRD)Negative Complete Response (CR) Per International Myeloma Working Group (IMWG) Criteria

Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma · Source last updated 2026-03-10

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
95% Confidence Interval
Time frame
8 months

What was measured

MRDnegative Complete Response (CR) per the IMWHG criteria is defined as absence of phenotypically aberrant clonal plasma cells by flow cytometry on bone marrow aspirates using the eight-color two tube approach with a minimum sensitivity of 1 in 10\^5 nucleated cells or higher.

Analysis population: 54/55 participants are evaluable for this outcome measure.

Groups in this outcome

All Participants

Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1) Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity. Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
All Participants54

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Participants70.4Not reported56.482.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        56.4
        upper Limit
        82.0
        value
        70.4
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    units
    Participants
description
MRDnegative Complete Response (CR) per the IMWHG criteria is defined as absence of phenotypically aberrant clonal plasma cells by flow cytometry on bone marrow aspirates using the eight-color two tube approach with a minimum sensitivity of 1 in 10\^5 nucleated cells or higher.
dispersion Type
95% Confidence Interval
groups
  1. description
    Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1) Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity. Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
    id
    OG000
    title
    All Participants
param Type
NUMBER
population Description
54/55 participants are evaluable for this outcome measure.
reporting Status
POSTED
time Frame
8 months
title
Percentage of Participants With Minimal Residual Disease (MRD)Negative Complete Response (CR) Per International Myeloma Working Group (IMWG) Criteria
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice