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NCT00603447 · OUTCOME

Number of Participants With Dose-limiting Toxicities

Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma · Source last updated 2017-05-30

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
Cycle 1, 28 days

What was measured

Dose-limiting toxicity was defined as any of the following events assessed as related to carfilzomib, lenalidomide, or dexamethasone: Nonhematologic * ≥ Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy * ≥ Grade 4 fatigue persisting \> 7 days * Treatment delay for toxicity \> 21 days Hematologic * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/mm³) \> 7 days * Febrile neutropenia (ANC \< 1,000/mm³ with fever ≥ 38.3ºC) * Grade 4 thrombocytopenia (platelets \< 25,000/mm³) for \> 7 days despite holding treatment, or Grade 3 or 4 thrombocytopenia associated with bleeding * Treatment delay for toxicity \> 21 days. The maximum-tolerated dose was defined as the dose level below which a drug-related DLT was observed in ≥ 33% of participants in a cohort.

Analysis population: Safety population for the dose escalation portion of the study

Groups in this outcome

1: CFZ 15 mg/m² + LEN 10 mg

Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.

2: CFZ 15 mg/m² + LEN 15 mg

Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.

3: CFZ 15 mg/m² + LEN 20 mg

Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.

4: CFZ 20 mg/m² + LEN 20 mg

Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.

5: CFZ 20 mg/m² + LEN 25 mg

Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.

6: CFZ 20/27 mg/m² + LEN 25 mg

Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.

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

Analysis denominator · Participants

GroupSource count
1: CFZ 15 mg/m² + LEN 10 mg6
2: CFZ 15 mg/m² + LEN 15 mg6
3: CFZ 15 mg/m² + LEN 20 mg8
4: CFZ 20 mg/m² + LEN 20 mg6
5: CFZ 20 mg/m² + LEN 25 mg6
6: CFZ 20/27 mg/m² + LEN 25 mg8

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1: CFZ 15 mg/m² + LEN 10 mg0Not reportedNot reportedNot reportedNot reported
2: CFZ 15 mg/m² + LEN 15 mg0Not reportedNot reportedNot reportedNot reported
3: CFZ 15 mg/m² + LEN 20 mg0Not reportedNot reportedNot reportedNot reported
4: CFZ 20 mg/m² + LEN 20 mg0Not reportedNot reportedNot reportedNot reported
5: CFZ 20 mg/m² + LEN 25 mg0Not reportedNot reportedNot reportedNot reported
6: CFZ 20/27 mg/m² + LEN 25 mg1Not 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
      6. group Id
        OG005
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      8
    units
    Participants
description
Dose-limiting toxicity was defined as any of the following events assessed as related to carfilzomib, lenalidomide, or dexamethasone: Nonhematologic * ≥ Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy * ≥ Grade 4 fatigue persisting \> 7 days * Treatment delay for toxicity \> 21 days Hematologic * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/mm³) \> 7 days * Febrile neutropenia (ANC \< 1,000/mm³ with fever ≥ 38.3ºC) * Grade 4 thrombocytopenia (platelets \< 25,000/mm³) for \> 7 days despite holding treatment, or Grade 3 or 4 thrombocytopenia associated with bleeding * Treatment delay for toxicity \> 21 days. The maximum-tolerated dose was defined as the dose level below which a drug-related DLT was observed in ≥ 33% of participants in a cohort.
groups
  1. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    OG000
    title
    1: CFZ 15 mg/m² + LEN 10 mg
  2. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    OG001
    title
    2: CFZ 15 mg/m² + LEN 15 mg
  3. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    OG002
    title
    3: CFZ 15 mg/m² + LEN 20 mg
  4. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    OG003
    title
    4: CFZ 20 mg/m² + LEN 20 mg
  5. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    OG004
    title
    5: CFZ 20 mg/m² + LEN 25 mg
  6. description
    Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    OG005
    title
    6: CFZ 20/27 mg/m² + LEN 25 mg
param Type
NUMBER
population Description
Safety population for the dose escalation portion of the study
reporting Status
POSTED
time Frame
Cycle 1, 28 days
title
Number of Participants With Dose-limiting Toxicities
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice