Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02003625 · OUTCOME

Number of Apheresis Sessions Required to Collect ≥ 4 x 10^6 CD34+ Cells/kg for Multiple Myeloma Patients and ≥ 2 x 10^6 CD34+ Cells/kg for Lymphoma Patients

Meloxicam vs Placebo for Mobilization · Source last updated 2020-05-18

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamide

Groups in this outcome

A. GCSF + Placebo

GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo

B. GCSF + Meloxicam

B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam

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

Analysis denominator · Participants

GroupSource count
A. GCSF + Placebo15
B. GCSF + Meloxicam15

Reported measurements

Source class 1

1 Session

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A. GCSF + Placebo4Not reportedNot reportedNot reportedNot reported
B. GCSF + Meloxicam4Not reportedNot reportedNot reportedNot reported

2 Sessions

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A. GCSF + Placebo6Not reportedNot reportedNot reportedNot reported
B. GCSF + Meloxicam10Not reportedNot reportedNot reportedNot reported

3 Sessions

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A. GCSF + Placebo4Not reportedNot reportedNot reportedNot reported
B. GCSF + Meloxicam1Not reportedNot reportedNot reportedNot reported

4 Sessions

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A. GCSF + Placebo1Not reportedNot reportedNot reportedNot reported
B. GCSF + Meloxicam0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      title
      1 Session
    2. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        10
      title
      2 Sessions
    3. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
      title
      3 Sessions
    4. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      4 Sessions
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      15
    units
    Participants
groups
  1. description
    GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo
    id
    OG000
    title
    A. GCSF + Placebo
  2. description
    B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam
    id
    OG001
    title
    B. GCSF + Meloxicam
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 6 days after the start of treatment or up to 12 days for multiple myeloma patients that received cyclophosphamide
title
Number of Apheresis Sessions Required to Collect ≥ 4 x 10^6 CD34+ Cells/kg for Multiple Myeloma Patients and ≥ 2 x 10^6 CD34+ Cells/kg for Lymphoma Patients
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice