Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00765102 · OUTCOME

Kaplan Meier Estimate for Time to Progression Assessed by the Investigator

Trial of Romidepsin and Bortezomib for Multiple Myeloma · Source last updated 2019-11-25

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
up to month 8

What was measured

Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator. Progressive Disease(PD):\>25% increase in serum monoclonal paraprotein, or \>25% plasma cells in marrow, or \>25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, \>= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia.

Analysis population: Intent to treat population. Analysis was not performed due to early termination of the study.

Groups in this outcome

Romidepsin + Bortezomib

Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight 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
Romidepsin + Bortezomib0

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 progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator. Progressive Disease(PD):\>25% increase in serum monoclonal paraprotein, or \>25% plasma cells in marrow, or \>25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, \>= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia.
groups
  1. description
    Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
    id
    OG000
    title
    Romidepsin + Bortezomib
population Description
Intent to treat population. Analysis was not performed due to early termination of the study.
reporting Status
POSTED
time Frame
up to month 8
title
Kaplan Meier Estimate for Time to Progression Assessed by the Investigator
type
SECONDARY

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

Preserved source evidence · Not medical advice