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NCT01729338 · OUTCOME

Maximum Depth of Response During Maintenance Therapy

Velcade + Cyclophosphamide in Newly Diagnosed Multiple Myeloma · Source last updated 2017-05-31

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
Up to 3 years

What was measured

Defined as maximum depth of response (ranging from partial response to complete response by International Myeloma Working Group (IMWG) criteria at any point during post-induction maintenance therapy. IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease.

Analysis population: 8 of all subjects reached maintenance and could be analyzed

Groups in this outcome

Velcade, Cyclophosphamide, Revlimid

INDUCTION (28-day cycles for 8 cycles): * VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15 * Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15 * Dexamethasone 40 mg PO days 1,8 and 15 MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death): * Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21 * Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15 Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until

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

Analysis denominator · Participants

GroupSource count
Velcade, Cyclophosphamide, Revlimid8

Reported measurements

Stable Disease
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Velcade, Cyclophosphamide, Revlimid13Not reportedNot reportedNot reportedNot reported
Partial Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Velcade, Cyclophosphamide, Revlimid0Not reportedNot reportedNot reportedNot reported
Very good partial response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Velcade, Cyclophosphamide, Revlimid50Not reportedNot reportedNot reportedNot reported
Complete Response/Stringent complete response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Velcade, Cyclophosphamide, Revlimid38Not reportedNot reportedNot reportedNot reported
Progressive Disease/no response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Velcade, Cyclophosphamide, Revlimid0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Stable Disease
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        50
    title
    Very good partial response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        38
    title
    Complete Response/Stringent complete response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Progressive Disease/no response
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Defined as maximum depth of response (ranging from partial response to complete response by International Myeloma Working Group (IMWG) criteria at any point during post-induction maintenance therapy. IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease.
groups
  1. description
    INDUCTION (28-day cycles for 8 cycles): * VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15 * Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15 * Dexamethasone 40 mg PO days 1,8 and 15 MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death): * Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21 * Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15 Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
    id
    OG000
    title
    Velcade, Cyclophosphamide, Revlimid
param Type
NUMBER
population Description
8 of all subjects reached maintenance and could be analyzed
reporting Status
POSTED
time Frame
Up to 3 years
title
Maximum Depth of Response During Maintenance Therapy
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice