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NCT02492750 · OUTCOME

Number of Participants Experiencing a Dose-limiting Toxicity (DLT)

Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma · Source last updated 2020-03-25

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
28 days

What was measured

Number of participants experiencing a dose-limiting toxicity (DLT) is reported below. Dose-limiting toxicity is graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Groups in this outcome

Phase I - Dose Level 1

Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.

Phase I - Dose Level 2

Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.

Phase I - Dose Level 3

Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.

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

Analysis denominator · Participants

GroupSource count
Phase I - Dose Level 14
Phase I - Dose Level 24
Phase I - Dose Level 36

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase I - Dose Level 20Not reportedNot reportedNot reportedNot reported
Phase I - Dose Level 30Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    MTD is defined as the dose level below the lowest dose that induces DLT in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    param Type
    Maximum Tolerated Dose (MTD) Level
    param Value
    3
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    MTD is defined as the dose level below the lowest dose that induces DLT in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    param Type
    Maximum Tolerated Dose (MTD) Level
    param Value
    3
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Number of participants experiencing a dose-limiting toxicity (DLT) is reported below. Dose-limiting toxicity is graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
groups
  1. description
    Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
    id
    OG000
    title
    Phase I - Dose Level 1
  2. description
    Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
    id
    OG001
    title
    Phase I - Dose Level 2
  3. description
    Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.
    id
    OG002
    title
    Phase I - Dose Level 3
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
28 days
title
Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice