Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00555906 · OUTCOME

Number of Participants With Laboratory Abnormalities: Phase 2

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma. · Source last updated 2015-03-19

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
Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib

What was measured

Laboratory parameters included hematology (hemoglobin, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid); electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium and phosphate); urinalysis (protein and immunology \[C reactive protein\]), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.

Analysis population: SAS included all enrolled participants who received at least 1 dose of study treatment.

Groups in this outcome

Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)

Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

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

Analysis denominator · Participants

GroupSource count
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)30

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Laboratory parameters included hematology (hemoglobin, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid); electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium and phosphate); urinalysis (protein and immunology \[C reactive protein\]), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.
groups
  1. description
    Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    OG000
    title
    Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)
param Type
NUMBER
population Description
SAS included all enrolled participants who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib
title
Number of Participants With Laboratory Abnormalities: Phase 2
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice