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NCT05014412 · OUTCOME

Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2

A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment · Source last updated 2026-02-10

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
Parts 1 and 2: Cycle 1 (28 days)

What was measured

CRS: supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T-cells and/or other immune effector cells. Symptoms must include fever at the onset, and may include hypotension, hypoxia and end organ dysfunction. As per ASTCT criteria, Grade (G) 1: fever (temperature \>=38 degree Celsius), hypotension and/or hypoxia none; G 2: fever, hypotension not requiring vasopressors, hypoxia requiring low-flow nasal cannula/ facemask or blow-by; G 3: fever, hypotension requiring a vasopressor with or without vasopressin, hypoxia requiring high-flow nasal cannula/ facemask, nonrebreather mask, or Venturi mask; G 4: fever, hypotension requiring multiple vasopressors (excluding vasopressin), hypoxia requiring positive pressure. Organ toxicities associated with CRS graded according to CTCAE v5.0. G 1: Mild, G 2: Moderate, G 3: severe, and G 4: life-threatening consequences; urgent intervention indicated. G 5: death related to AE.

Analysis population: Safety analysis set included all enrolled participants who received at least 1 dose of study intervention. Data for this outcome is presented for all participants in Part 1 and 2 of the study (combined) per study design, as all treatment groups utilized the same elranatamab priming regimen (4 mg on Day 1/20 mg on Day 4, followed by 76mg QW) during Cycle 1.

Groups in this outcome

All Participants

All participants who were enrolled and treated in Part 1 and 2 of the study and evaluated for CRS.

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

Analysis denominator · Participants

GroupSource count
All Participants85

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    units
    Participants
description
CRS: supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T-cells and/or other immune effector cells. Symptoms must include fever at the onset, and may include hypotension, hypoxia and end organ dysfunction. As per ASTCT criteria, Grade (G) 1: fever (temperature \>=38 degree Celsius), hypotension and/or hypoxia none; G 2: fever, hypotension not requiring vasopressors, hypoxia requiring low-flow nasal cannula/ facemask or blow-by; G 3: fever, hypotension requiring a vasopressor with or without vasopressin, hypoxia requiring high-flow nasal cannula/ facemask, nonrebreather mask, or Venturi mask; G 4: fever, hypotension requiring multiple vasopressors (excluding vasopressin), hypoxia requiring positive pressure. Organ toxicities associated with CRS graded according to CTCAE v5.0. G 1: Mild, G 2: Moderate, G 3: severe, and G 4: life-threatening consequences; urgent intervention indicated. G 5: death related to AE.
groups
  1. description
    All participants who were enrolled and treated in Part 1 and 2 of the study and evaluated for CRS.
    id
    OG000
    title
    All Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all enrolled participants who received at least 1 dose of study intervention. Data for this outcome is presented for all participants in Part 1 and 2 of the study (combined) per study design, as all treatment groups utilized the same elranatamab priming regimen (4 mg on Day 1/20 mg on Day 4, followed by 76mg QW) during Cycle 1.
reporting Status
POSTED
time Frame
Parts 1 and 2: Cycle 1 (28 days)
title
Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice