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NCT02492750 · OUTCOME

Number of Participants Who Experienced at Least One Grade 3+ Adverse Events Deemed at Least Possibly Related to Treatment, Graded According to NCI CTCAE Version 4.0

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
Up to 41 months

What was measured

The number of participants who experienced at least one grade 3+ adverse events deemed at least possibly related to treatment, graded according to NCI CTCAE version 4.0, is reported below.

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 12Not reportedNot reportedNot reportedNot reported
Phase I - Dose Level 23Not reportedNot reportedNot reportedNot reported
Phase I - Dose Level 33Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      6
    units
    Participants
description
The number of participants who experienced at least one grade 3+ adverse events deemed at least possibly related to treatment, graded according to NCI CTCAE version 4.0, is reported below.
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
Up to 41 months
title
Number of Participants Who Experienced at Least One Grade 3+ Adverse Events Deemed at Least Possibly Related to Treatment, Graded According to NCI CTCAE Version 4.0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice