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NCT01355705 · OUTCOME

Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria

Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma · Source last updated 2018-09-18

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
12 weeks

What was measured

Modified International Myeloma Working Group Uniform Response Criteria: Complete (CR)= * Negative for monoclonal protein (MP) in urine (U) and serum (S) + * No tissue plasmacytomas (PC) + * \<5% plasma cells (PCs) in marrow (M) Stringent CR (sCR)= CR with normal light chain ratio+ no PCs in M Near CR (nCR)= CR, except MP persists in U and S Partial (PR)= S MP ≤50%, + U MP ≤90% or \<200 mg/24 hours (hr) Very Good PR (VGPR)= in S MP ≤90%, + U MP \<100 mg/24 hr Minimal (MR)= * S MP ≤51-75%, + * If light chain is excreted, reduced 50-89%/24 hr that is also \>200 mg/24 hr, + * No increase in lytic bone lesions Progressive disease (PD)= any of: * S MP ≥125% and/or ≥+0.5 g/dL, * U MP ≥125% and/or ≥+200 mg/24 hr * New or increased bone lesions/PC * S calcium \>11.5 mg/dL (attributed to increased PCs) PD after CR/sCR= * Reappearance of S or U MP * ≥5% clonal PCs in M * New PC, lytic bone lesions, hypercalcemia Stable Disease (SD)= Not CR, VGPR, MR, PR, or PD

Groups in this outcome

Amrubicin + Lenalidomide + Dexamethasone

Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles. Concurrent therapeutic medications: * Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14 * Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15) Other drugs: * Aspirin: 81 or 325 mg daily oral * Pegfilgrastim subcutaneous on Day 2

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

Analysis denominator · Participants

GroupSource count
Amrubicin + Lenalidomide + Dexamethasone13

Reported measurements

Complete Response (CR) rate
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amrubicin + Lenalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR) Rate
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amrubicin + Lenalidomide + Dexamethasone7.6Not reportedNot reportedNot reportedNot reported
Total CR + VGPR
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amrubicin + Lenalidomide + Dexamethasone7.6Not reportedNot reportedNot reportedNot reported
Partial Response (PR) Rate
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amrubicin + Lenalidomide + Dexamethasone15.4Not reportedNot reportedNot reportedNot reported
Overall Response Rate (ORR = CR + VGPR + PR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amrubicin + Lenalidomide + Dexamethasone23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Response (CR) rate
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7.6
    title
    Very Good Partial Response (VGPR) Rate
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7.6
    title
    Total CR + VGPR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        15.4
    title
    Partial Response (PR) Rate
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    Overall Response Rate (ORR = CR + VGPR + PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Modified International Myeloma Working Group Uniform Response Criteria: Complete (CR)= * Negative for monoclonal protein (MP) in urine (U) and serum (S) + * No tissue plasmacytomas (PC) + * \<5% plasma cells (PCs) in marrow (M) Stringent CR (sCR)= CR with normal light chain ratio+ no PCs in M Near CR (nCR)= CR, except MP persists in U and S Partial (PR)= S MP ≤50%, + U MP ≤90% or \<200 mg/24 hours (hr) Very Good PR (VGPR)= in S MP ≤90%, + U MP \<100 mg/24 hr Minimal (MR)= * S MP ≤51-75%, + * If light chain is excreted, reduced 50-89%/24 hr that is also \>200 mg/24 hr, + * No increase in lytic bone lesions Progressive disease (PD)= any of: * S MP ≥125% and/or ≥+0.5 g/dL, * U MP ≥125% and/or ≥+200 mg/24 hr * New or increased bone lesions/PC * S calcium \>11.5 mg/dL (attributed to increased PCs) PD after CR/sCR= * Reappearance of S or U MP * ≥5% clonal PCs in M * New PC, lytic bone lesions, hypercalcemia Stable Disease (SD)= Not CR, VGPR, MR, PR, or PD
groups
  1. description
    Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles. Concurrent therapeutic medications: * Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14 * Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15) Other drugs: * Aspirin: 81 or 325 mg daily oral * Pegfilgrastim subcutaneous on Day 2
    id
    OG000
    title
    Amrubicin + Lenalidomide + Dexamethasone
param Type
NUMBER
reporting Status
POSTED
time Frame
12 weeks
title
Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice