Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01965834 · OUTCOME

Rate of Response in Participants Receiving Fenofibrate Therapy

Phase II Study to Evaluate Fenofibrate Therapy in Patients With Smoldering or Symptomatic Multiple Myeloma · Source last updated 2017-06-14

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
After two cycles, about 2 months

What was measured

To determine response rate (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), and Partial Response (PR)) in multiple myeloma patients receiving oral fenofibrate therapy. Response will be measured by serum and urine protein electrophoresis and immunofixation, as well as by percentage of plasma cells present on bone marrow biopsy.

Analysis population: No participants achieved response to protocol therapy (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), or Partial Response (PR)). Two (2) patients had stable disease (SD); one (1) patient achieved Stable Disease/clinical Progressive Disease, and three (3) patients had progressive disease (PD).

Groups in this outcome

Fenofibrate Therapy

Fenofibrate orally daily for each 28 day cycle, per study protocol. Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.

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

Analysis denominator · Participants

GroupSource count
Fenofibrate Therapy6

Reported measurements

Strict Complete Response (sCR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fenofibrate Therapy0Not reportedNot reportedNot reportedNot reported
Complete response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fenofibrate Therapy0Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VgPR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fenofibrate Therapy0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fenofibrate Therapy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Strict Complete Response (sCR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Very Good Partial Response (VgPR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial Response (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
To determine response rate (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), and Partial Response (PR)) in multiple myeloma patients receiving oral fenofibrate therapy. Response will be measured by serum and urine protein electrophoresis and immunofixation, as well as by percentage of plasma cells present on bone marrow biopsy.
groups
  1. description
    Fenofibrate orally daily for each 28 day cycle, per study protocol. Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.
    id
    OG000
    title
    Fenofibrate Therapy
param Type
NUMBER
population Description
No participants achieved response to protocol therapy (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), or Partial Response (PR)). Two (2) patients had stable disease (SD); one (1) patient achieved Stable Disease/clinical Progressive Disease, and three (3) patients had progressive disease (PD).
reporting Status
POSTED
time Frame
After two cycles, about 2 months
title
Rate of Response in Participants Receiving Fenofibrate Therapy
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice