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NCT03871829 · OUTCOME

Progression Free Survival (PFS)

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab · Source last updated 2025-03-30

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

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
Up to 3 years and 7 months

What was measured

PFS was defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. IMWG criteria for PD: \>=25% from lowest response level in serum M-component (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]) and/or in urine M-component (the absolute increase must be \>=200 mg/24 hour); only in participants without measurable serum and urine M-protein levels: increase of \>=25% in the difference between involved and uninvolved free light chain levels and the absolute increase must be \>10 mg/dL. BMPC%: the absolute % must be \>=10%; definite increase in size of existing bone lesions or soft tissue plasmacytomas; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 milligrams per deciliter (mg/dL) or 2.65 millimoles per liter \[mmol/L\]) that can be attributed solely to PC proliferative disorder.

Analysis population: Intent-to-treat (ITT) analysis set included all participants who were randomized in the study. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Groups in this outcome

Arm A: Carfilzomib+Dexamethasone (Kd)

Participants received carfilzomib 20 milligram per meter square (mg/m\^2) intravenously (IV) on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and thereafter on Days 1, 8, 15 from Cycle 2 onwards. Participants received dexamethasone 20 milligrams (mg) on Cycle 1 Days 1 and 2, and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed progressive disease (PD), death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.

Arm B: Dara-SC in Combination With Kd (DKd)

Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.

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

Analysis denominator · Participants

GroupSource count
Arm A: Carfilzomib+Dexamethasone (Kd)27
Arm B: Dara-SC in Combination With Kd (DKd)24

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Carfilzomib+Dexamethasone (Kd)10.614.704.7019.88Not reported
Arm B: Dara-SC in Combination With Kd (DKd)10.747.497.4916.16Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.70
        spread
        4.70
        upper Limit
        19.88
        value
        10.61
      2. group Id
        OG001
        lower Limit
        7.49
        spread
        7.49
        upper Limit
        16.16
        value
        10.74
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      24
    units
    Participants
description
PFS was defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. IMWG criteria for PD: \>=25% from lowest response level in serum M-component (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]) and/or in urine M-component (the absolute increase must be \>=200 mg/24 hour); only in participants without measurable serum and urine M-protein levels: increase of \>=25% in the difference between involved and uninvolved free light chain levels and the absolute increase must be \>10 mg/dL. BMPC%: the absolute % must be \>=10%; definite increase in size of existing bone lesions or soft tissue plasmacytomas; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 milligrams per deciliter (mg/dL) or 2.65 millimoles per liter \[mmol/L\]) that can be attributed solely to PC proliferative disorder.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received carfilzomib 20 milligram per meter square (mg/m\^2) intravenously (IV) on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and thereafter on Days 1, 8, 15 from Cycle 2 onwards. Participants received dexamethasone 20 milligrams (mg) on Cycle 1 Days 1 and 2, and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed progressive disease (PD), death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
    id
    OG000
    title
    Arm A: Carfilzomib+Dexamethasone (Kd)
  2. description
    Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
    id
    OG001
    title
    Arm B: Dara-SC in Combination With Kd (DKd)
param Type
MEDIAN
population Description
Intent-to-treat (ITT) analysis set included all participants who were randomized in the study. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to 3 years and 7 months
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice