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NCT00429949 · OUTCOME

Response Rate [Complete Response (CR) and Partial Response (PR)]

A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma · Source last updated 2014-08-29

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
Completion of treatment (median duration of therapy was 51 days)

What was measured

CR requires all of the following: * Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR. * \< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow. * No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of soft tissue plasmacytoma PR requires all of the following: * 50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks. -Reduction in 24 hr urinary light chain excretion by either \> 90% or to \< 200 mg, maintained for a minimum of 6 weeks. * 50% reduction in the size of soft tissue plas

Groups in this outcome

Dasatinib 70 mg BID

Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.

Dasatinib 100 mg BID

In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Dasatinib 70 mg BID21
Dasatinib 100 mg BID6

Reported measurements

Complete response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 70 mg BID0Not reported0.517.3Not reported
Dasatinib 100 mg BID0Not reportedNot reportedNot reportedNot reported
Partial response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 70 mg BID0Not reportedNot reportedNot reportedNot reported
Dasatinib 100 mg BID1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        17.3
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Partial response
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      6
    units
    Participants
description
CR requires all of the following: * Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR. * \< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow. * No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of soft tissue plasmacytoma PR requires all of the following: * 50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks. -Reduction in 24 hr urinary light chain excretion by either \> 90% or to \< 200 mg, maintained for a minimum of 6 weeks. * 50% reduction in the size of soft tissue plas
groups
  1. description
    Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
    id
    OG000
    title
    Dasatinib 70 mg BID
  2. description
    In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
    id
    OG001
    title
    Dasatinib 100 mg BID
param Type
NUMBER
reporting Status
POSTED
time Frame
Completion of treatment (median duration of therapy was 51 days)
title
Response Rate [Complete Response (CR) and Partial Response (PR)]
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice