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NCT00600353 · FLOW

Participant flow

Multi-day Doses in Prevention of Nausea and Emesis · Source last updated 2017-03-09

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

groups
  1. description
    Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
    id
    FG000
    title
    Group A - Subjects With Multiple Myeloma
  2. description
    Group B: Subjects with Lymphoma * Conditioning regimen, over a 7 day period, includes: (BEAC) * carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
    id
    FG001
    title
    Group B - Subjects With Relpased Lymphoma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      history of malignancy within 5 years
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      History of prepartive regimen
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Emetic responses were assessed by daily patient diaries and the Multinational Association for Supportive Care in Cancer Antiemetic Tool (MAT). Nausea was measured using a Nausea Visual Score (NVS) of 0 to 10 with score of 0 having no nausea. A "modified" Osoba module was used to assess quality of life (QOL).
recruitment Details
20 patients undergoing Autologous Stem Cell Transplant (ASCT) for multiple myeloma (MM) (n=10) and relapsed lymphoma (n=10) at the University of Kansas Medical Center were enrolled. 2 patients were excluded from analysis - both patients met exclusion criteria
Complete source fields
groups
  1. description
    Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
    id
    FG000
    title
    Group A - Subjects With Multiple Myeloma
  2. description
    Group B: Subjects with Lymphoma * Conditioning regimen, over a 7 day period, includes: (BEAC) * carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
    id
    FG001
    title
    Group B - Subjects With Relpased Lymphoma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      history of malignancy within 5 years
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      History of prepartive regimen
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Emetic responses were assessed by daily patient diaries and the Multinational Association for Supportive Care in Cancer Antiemetic Tool (MAT). Nausea was measured using a Nausea Visual Score (NVS) of 0 to 10 with score of 0 having no nausea. A "modified" Osoba module was used to assess quality of life (QOL).
recruitment Details
20 patients undergoing Autologous Stem Cell Transplant (ASCT) for multiple myeloma (MM) (n=10) and relapsed lymphoma (n=10) at the University of Kansas Medical Center were enrolled. 2 patients were excluded from analysis - both patients met exclusion criteria

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