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NCT01754402 · OUTCOME

Initial Response Rate

Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma · Source last updated 2024-02-20

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
2 cycles (approximately 2 months)

What was measured

The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as: CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR- \> 50% reduction of serum M-protein and urine M-protein by \>90% or to \< 200 mg/24 h In addition, if present at baseline, a \> 50% reduction in the size of soft tissue plasmacytomas is also required VGPR - Serum and urine M-protein detectable by immunofixation but n

Analysis population: The overall number of participants analyzed reflects those who received at least 2 cycles of treatment. These participants were assessed for response at that time. The data reported indicates how many patients out of each cohort experienced at least a partial response or complete response.

Groups in this outcome

Cohort 1: 120mg Bendamustine + 3mg Pomalidomide

* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression. Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.

Cohort 2: 120mg Bendamustine + 4mg Pomalidomide

* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression. Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.

Expansion: 120mg Bendamustine + 3mg Pomalidomide

* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression. Study treatment will be administered at the Maximum Tolerated Dose.

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

Analysis denominator · Participants

GroupSource count
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide5
Cohort 2: 120mg Bendamustine + 4mg Pomalidomide0
Expansion: 120mg Bendamustine + 3mg Pomalidomide27

Reported measurements

Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide1Not reportedNot reportedNot reportedNot reported
Expansion: 120mg Bendamustine + 3mg Pomalidomide11Not reportedNot reportedNot reportedNot reported
Very Good Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide0Not reportedNot reportedNot reportedNot reported
Expansion: 120mg Bendamustine + 3mg Pomalidomide2Not reportedNot reportedNot reportedNot reported
Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide0Not reportedNot reportedNot reportedNot reported
Expansion: 120mg Bendamustine + 3mg Pomalidomide0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG002
        value
        11
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG002
        value
        2
    title
    Very Good Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG002
        value
        0
    title
    Complete Response
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      27
    units
    Participants
description
The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as: CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR- \> 50% reduction of serum M-protein and urine M-protein by \>90% or to \< 200 mg/24 h In addition, if present at baseline, a \> 50% reduction in the size of soft tissue plasmacytomas is also required VGPR - Serum and urine M-protein detectable by immunofixation but n
groups
  1. description
    * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression. Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.
    id
    OG000
    title
    Cohort 1: 120mg Bendamustine + 3mg Pomalidomide
  2. description
    * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression. Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.
    id
    OG001
    title
    Cohort 2: 120mg Bendamustine + 4mg Pomalidomide
  3. description
    * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression. Study treatment will be administered at the Maximum Tolerated Dose.
    id
    OG002
    title
    Expansion: 120mg Bendamustine + 3mg Pomalidomide
param Type
COUNT_OF_PARTICIPANTS
population Description
The overall number of participants analyzed reflects those who received at least 2 cycles of treatment. These participants were assessed for response at that time. The data reported indicates how many patients out of each cohort experienced at least a partial response or complete response.
reporting Status
POSTED
time Frame
2 cycles (approximately 2 months)
title
Initial Response Rate
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice