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NCT01651039 · OUTCOME

Response Rates for Len Refractory Patients

Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM) · Source last updated 2018-04-09

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 4 years

What was measured

Response Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003). CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component \<100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to \<200 mg per 24 h MR-≥ 25% but \< 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 - 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25-49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions. SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline

Groups in this outcome

Panobinostat, Lenalidomide and Dexamethasone

All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol

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

Analysis denominator · Participants

GroupSource count
Panobinostat, Lenalidomide and Dexamethasone22

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat, Lenalidomide and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Very Good Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat, Lenalidomide and Dexamethasone4Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat, Lenalidomide and Dexamethasone3Not reportedNot reportedNot reportedNot reported
Minimal Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat, Lenalidomide and Dexamethasone7Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat, Lenalidomide and Dexamethasone6Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat, Lenalidomide and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Very Good Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Minimal Response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Stable Disease
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Response Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003). CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component \<100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to \<200 mg per 24 h MR-≥ 25% but \< 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 - 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25-49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions. SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline
groups
  1. description
    All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
    id
    OG000
    title
    Panobinostat, Lenalidomide and Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
up to 4 years
title
Response Rates for Len Refractory Patients
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice