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NCT04430894 · OUTCOME

Progression Free Survival at 12 Months

KRDI in Transplant-Eligible MM · Source last updated 2026-06-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
12 months

What was measured

Progression free survival (PFS) is defined as the time between the start of treatment and disease progression or death due to any cause. PFS at 12 months is the percentage of patients who were alive and without disease progression 12 months after initiating treatment with of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI).

Groups in this outcome

Induction

All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.) For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation). For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles. Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only). Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).

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

Analysis denominator · Participants

GroupSource count
Induction47

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Induction97.9Not reported95.999.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        95.9
        upper Limit
        99.7
        value
        97.9
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    units
    Participants
description
Progression free survival (PFS) is defined as the time between the start of treatment and disease progression or death due to any cause. PFS at 12 months is the percentage of patients who were alive and without disease progression 12 months after initiating treatment with of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI).
dispersion Type
95% Confidence Interval
groups
  1. description
    All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.) For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation). For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles. Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only). Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
    id
    OG000
    title
    Induction
param Type
NUMBER
reporting Status
POSTED
time Frame
12 months
title
Progression Free Survival at 12 Months
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice