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NCT00004088 · OUTCOME

Best Response at 6 Months Post Tandem Autologous Stem Cell Transplant

Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma · Source last updated 2019-07-02

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
Six months after day 0 of the first cycle of the tandem autologous stem cell transplant. This will be used to determine administration of thalidomide.

What was measured

Response gradations are specified in the "Blade criteria", Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs.

Groups in this outcome

HD Chemo Followed by PBPC Rescue

Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover. filgrastim recombinant interferon alfa busulfan cyclophosphamide melphalan pamidronate disodium thalidomide peripheral blood stem cell transplantation

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

Analysis denominator · Participants

GroupSource count
HD Chemo Followed by PBPC Rescue63

Reported measurements

Source class 1

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo Followed by PBPC Rescue18Not reportedNot reportedNot reportedNot reported

VGPR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo Followed by PBPC Rescue5Not reportedNot reportedNot reportedNot reported

PR/SD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo Followed by PBPC Rescue29Not reportedNot reportedNot reportedNot reported

PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HD Chemo Followed by PBPC Rescue11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      title
      CR
    2. measurements
      1. group Id
        OG000
        value
        5
      title
      VGPR
    3. measurements
      1. group Id
        OG000
        value
        29
      title
      PR/SD
    4. measurements
      1. group Id
        OG000
        value
        11
      title
      PD
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
description
Response gradations are specified in the "Blade criteria", Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs.
groups
  1. description
    Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover. filgrastim recombinant interferon alfa busulfan cyclophosphamide melphalan pamidronate disodium thalidomide peripheral blood stem cell transplantation
    id
    OG000
    title
    HD Chemo Followed by PBPC Rescue
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Six months after day 0 of the first cycle of the tandem autologous stem cell transplant. This will be used to determine administration of thalidomide.
title
Best Response at 6 Months Post Tandem Autologous Stem Cell Transplant
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice