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NCT01335685 · OUTCOME

Time to Next Therapy (Phase 2)

Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma · Source last updated 2018-01-23

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
From the date of enrollment to the date of subsequent antineoplastic therapy for up to 5.5 years

What was measured

Time to Next Therapy is defined as time from the date of enrollment to the date of subsequent antineoplastic therapy.

Analysis population: Time to next therapy was not analyzed due to the change in the planned analysis.

Groups in this outcome

Arm B: Ixazomib 4.0 mg (RP2D)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).

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

Analysis denominator · Participants

GroupSource count
Arm B: Ixazomib 4.0 mg (RP2D)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Time to Next Therapy is defined as time from the date of enrollment to the date of subsequent antineoplastic therapy.
groups
  1. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
    id
    OG000
    title
    Arm B: Ixazomib 4.0 mg (RP2D)
population Description
Time to next therapy was not analyzed due to the change in the planned analysis.
reporting Status
POSTED
time Frame
From the date of enrollment to the date of subsequent antineoplastic therapy for up to 5.5 years
title
Time to Next Therapy (Phase 2)
type
SECONDARY

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

Preserved source evidence · Not medical advice