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NCT01029054 · OUTCOME

The Percentage of Patients That Achieve a Response to Treatment

Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma · Source last updated 2017-01-30

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
4 Months After Treatment Start

What was measured

The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined. sCR is defined as: * Negative immunofixation on the serum and urine and * Disappearance of any soft tissue plasmacytomas and * \< 5% plasma cells in bone marrow and * Normal SFLC ratio and * Absence of clonal cells in bone marrow VGPR is defined as: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis or * ≥ 90% reduction in serum M-component with urine M-component \< 100 mg per 24 hours PR is defined as: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours * If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required

Groups in this outcome

Carfilzomib, Lenalidomide w/Dexamethasone

Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.

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

Analysis denominator · Participants

GroupSource count
Carfilzomib, Lenalidomide w/Dexamethasone53

Reported measurements

% of patients that achieve at least a sCR
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib, Lenalidomide w/Dexamethasone42Not reportedNot reportedNot reportedNot reported
% of patients that achieve at least a VGPR
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib, Lenalidomide w/Dexamethasone81Not reportedNot reportedNot reportedNot reported
% of patients that achieve at least a PR
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib, Lenalidomide w/Dexamethasone98Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
    title
    % of patients that achieve at least a sCR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        81
    title
    % of patients that achieve at least a VGPR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        98
    title
    % of patients that achieve at least a PR
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    units
    Participants
description
The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined. sCR is defined as: * Negative immunofixation on the serum and urine and * Disappearance of any soft tissue plasmacytomas and * \< 5% plasma cells in bone marrow and * Normal SFLC ratio and * Absence of clonal cells in bone marrow VGPR is defined as: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis or * ≥ 90% reduction in serum M-component with urine M-component \< 100 mg per 24 hours PR is defined as: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours * If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required
groups
  1. description
    Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
    id
    OG000
    title
    Carfilzomib, Lenalidomide w/Dexamethasone
param Type
NUMBER
reporting Status
POSTED
time Frame
4 Months After Treatment Start
title
The Percentage of Patients That Achieve a Response to Treatment
type
PRIMARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice