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NCT01969565 · OUTCOME

Tolerability and Safety of Increasing Doses of Carfilzomib in Combination With Dexamethasone.

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
24 months

What was measured

Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) adverse event dictionary. The results will be tabulated to examine their frequency, organ systems affected, and relationship to study treatment. The results of laboratory assessments will be evaluated similarly.

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. Carfilzomib Dexamethasone

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
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) adverse event dictionary. The results will be tabulated to examine their frequency, organ systems affected, and relationship to study treatment. The results of laboratory assessments will be evaluated similarly.
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. Carfilzomib Dexamethasone
    id
    OG000
    title
    Carfilzomib in Combination With Dexamethasone
population Description
Patient withdrew consent before receiving treatment
reporting Status
POSTED
time Frame
24 months
title
Tolerability and Safety of Increasing Doses of Carfilzomib in Combination With Dexamethasone.
type
PRIMARY

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

Preserved source evidence · Not medical advice