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NCT01034553 · OUTCOME

Dose-limiting Toxicity (DLT) (Phase I)

Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2016-05-25

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
28 days

What was measured

Patients were evaluated over the first cycle of treatment for Dose Limiting Toxicities. For this trail DLTs are as follows: An AE attributed (definitely, probably, or possibly) to study treatment during cycle 1 and the following criteria: Grade 4 Neutropenia Grade 4 Thrombocytopenia, or grade 3 with bleeding Febrile neutropenia Creatinine serum great than 2 times baseline or upper limit of normal Grade 3 or higher Fatigue Grade 3 or higher nausea, vomiting, or diarrhea Any grade 3 or higher Non-hematologic toxicity per NCI CTCAE V4.0 Inability to initiate the scheduled cycle 2, day 1 due to toxicity The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose.

Groups in this outcome

Dose 0**

Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV

Dose 0

Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV

Dose 1

Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV

Dose 2

Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV

Dose 3

Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV

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

Analysis denominator · Participants

GroupSource count
Dose 0**3
Dose 04
Dose 13
Dose 23
Dose 36

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose 0**0Not reportedNot reportedNot reportedNot reported
Dose 00Not reportedNot reportedNot reportedNot reported
Dose 10Not reportedNot reportedNot reportedNot reported
Dose 20Not reportedNot reportedNot reportedNot reported
Dose 30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      6
    units
    Participants
description
Patients were evaluated over the first cycle of treatment for Dose Limiting Toxicities. For this trail DLTs are as follows: An AE attributed (definitely, probably, or possibly) to study treatment during cycle 1 and the following criteria: Grade 4 Neutropenia Grade 4 Thrombocytopenia, or grade 3 with bleeding Febrile neutropenia Creatinine serum great than 2 times baseline or upper limit of normal Grade 3 or higher Fatigue Grade 3 or higher nausea, vomiting, or diarrhea Any grade 3 or higher Non-hematologic toxicity per NCI CTCAE V4.0 Inability to initiate the scheduled cycle 2, day 1 due to toxicity The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose.
groups
  1. description
    Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV
    id
    OG000
    title
    Dose 0**
  2. description
    Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV
    id
    OG001
    title
    Dose 0
  3. description
    Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV
    id
    OG002
    title
    Dose 1
  4. description
    Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV
    id
    OG003
    title
    Dose 2
  5. description
    Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22. \> \> Aurora A kinase inhibitor MLN8237: Given orally \> \> bortezomib: Given IV
    id
    OG004
    title
    Dose 3
param Type
NUMBER
reporting Status
POSTED
time Frame
28 days
title
Dose-limiting Toxicity (DLT) (Phase I)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice