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NCT02441686 · OUTCOME

Induction Overall Response Rate (ORR)

Phase II Study of Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma · Source last updated 2026-01-13

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
Participants were followed up to 24 weeks.

What was measured

Induction ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during induction therapy either 4 cycles or 8 cycles of combination therapy. Response on ASCT is not included.

Analysis population: Evaluable for disease response analysis having started therapy and assessed for disease post-baseline.

Groups in this outcome

Lenalidomide, Subcutaneous Bortezomib, Dexamethasone

Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone40

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone97.5Not reported8999Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        89
        upper Limit
        99
        value
        97.5
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
Induction ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during induction therapy either 4 cycles or 8 cycles of combination therapy. Response on ASCT is not included.
dispersion Type
90% Confidence Interval
groups
  1. description
    Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
    id
    OG000
    title
    Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
param Type
NUMBER
population Description
Evaluable for disease response analysis having started therapy and assessed for disease post-baseline.
reporting Status
POSTED
time Frame
Participants were followed up to 24 weeks.
title
Induction Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice