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NCT02903381 · OUTCOME

Number of Participants With Adverse Events

A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma · Source last updated 2023-06-13

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
Baseline to 2 Years

What was measured

For toxicity reporting, all adverse events and laboratory abnormalities will be graded and analyzed using CTCAE version 4 as appropriate.

Groups in this outcome

Nivolumab, Lenalidomide, Dexamethasone

* A treatment cycle is defined as 28 consecutive days. * Participants will receive 6 cycles of induction therapy followed by 6 cycles of maintenance therapy with lower doses of lenalidomide and no dexamethasone for a total of 12 months. Nivolumab: Intravenous, predetermined dosage, Days 1 and 15 during cycles 1-12 and Lenalidomide: Oral, predetermined dosage, Days 1-21 of cycle 1-12 Dexamethasone: Oral, Days 1, 8, 15 of cycle 1-6

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

Analysis denominator · Participants

GroupSource count
Nivolumab, Lenalidomide, Dexamethasone8

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab, Lenalidomide, Dexamethasone8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
For toxicity reporting, all adverse events and laboratory abnormalities will be graded and analyzed using CTCAE version 4 as appropriate.
groups
  1. description
    * A treatment cycle is defined as 28 consecutive days. * Participants will receive 6 cycles of induction therapy followed by 6 cycles of maintenance therapy with lower doses of lenalidomide and no dexamethasone for a total of 12 months. Nivolumab: Intravenous, predetermined dosage, Days 1 and 15 during cycles 1-12 and Lenalidomide: Oral, predetermined dosage, Days 1-21 of cycle 1-12 Dexamethasone: Oral, Days 1, 8, 15 of cycle 1-6
    id
    OG000
    title
    Nivolumab, Lenalidomide, Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Baseline to 2 Years
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice