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NCT01969565 · OUTCOME

Overall Response Rate (ORR), Defined as sCR, CR, Very Good Partial Response (VGPR), and PR at 4 Cycles

Study of Carfilzomib in Combination w/Dexamethasone in Patients w/Newly Diagnosed Multiple Myeloma · Source last updated 2017-11-24

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
4 months

What was measured

The ORR will be estimated based on the crude proportion of subjects for whom best overall response is sCR, CR, VGPR, and PR.

Analysis population: Patient withdrew consent before receiving treatment

Groups in this outcome

Carfilzomib in Combination With Dexamethasone

Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.

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 in Combination With Dexamethasone0

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
The ORR will be estimated based on the crude proportion of subjects for whom best overall response is sCR, CR, VGPR, and PR.
groups
  1. description
    Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
    id
    OG000
    title
    Carfilzomib in Combination With Dexamethasone
population Description
Patient withdrew consent before receiving treatment
reporting Status
POSTED
time Frame
4 months
title
Overall Response Rate (ORR), Defined as sCR, CR, Very Good Partial Response (VGPR), and PR at 4 Cycles
type
SECONDARY

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

Preserved source evidence · Not medical advice