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NCT04896658 · OUTCOME

Number of Participants According to Best Response

Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma · Source last updated 2025-04-03

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
From date of randomization until the date of death from any cause, assessed up to 3 years

What was measured

Best Response (Not including Overall Survival (OS) response)

Analysis population: Phase II of the expansion cohort was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate. 0 patients were enrolled in the Phase II expansion Cohort, therefore, there is no data to report in the data table.

Groups in this outcome

Arm A - Dose Level 1

(1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug

Arm A - Dose Level 2

(2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug

Arm B - Dose Level 1

(1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug

Arm B - Dose Level 2

(2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug

Phase II : Expansion Cohort

Once tolerability of the highest planned dose is established, patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.

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 - Dose Level 13
Arm A - Dose Level 20
Arm B - Dose Level 13
Arm B - Dose Level 24
Phase II : Expansion Cohort0

Reported measurements

Source class 1

Stable Disease (SD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Dose Level 11Not reportedNot reportedNot reportedNot reported
Arm A - Dose Level 20Not reportedNot reportedNot reportedNot reported
Arm B - Dose Level 12Not reportedNot reportedNot reportedNot reported
Arm B - Dose Level 22Not reportedNot reportedNot reportedNot reported
Phase II : Expansion Cohort0Not reportedNot reportedNot reportedNot reported

Partial Response (PR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Dose Level 12Not reportedNot reportedNot reportedNot reported
Arm A - Dose Level 20Not reportedNot reportedNot reportedNot reported
Arm B - Dose Level 11Not reportedNot reportedNot reportedNot reported
Arm B - Dose Level 21Not reportedNot reportedNot reportedNot reported
Phase II : Expansion Cohort0Not reportedNot reportedNot reportedNot reported

Very good partial response (VGPR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Dose Level 10Not reportedNot reportedNot reportedNot reported
Arm A - Dose Level 20Not reportedNot reportedNot reportedNot reported
Arm B - Dose Level 10Not reportedNot reportedNot reportedNot reported
Arm B - Dose Level 21Not reportedNot reportedNot reportedNot reported
Phase II : Expansion Cohort0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      title
      Stable Disease (SD)
    2. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      title
      Partial Response (PR)
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      title
      Very good partial response (VGPR)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      0
    units
    Participants
description
Best Response (Not including Overall Survival (OS) response)
groups
  1. description
    (1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
    id
    OG000
    title
    Arm A - Dose Level 1
  2. description
    (2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
    id
    OG001
    title
    Arm A - Dose Level 2
  3. description
    (1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
    id
    OG002
    title
    Arm B - Dose Level 1
  4. description
    (2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
    id
    OG003
    title
    Arm B - Dose Level 2
  5. description
    Once tolerability of the highest planned dose is established, patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.
    id
    OG004
    title
    Phase II : Expansion Cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
Phase II of the expansion cohort was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate. 0 patients were enrolled in the Phase II expansion Cohort, therefore, there is no data to report in the data table.
reporting Status
POSTED
time Frame
From date of randomization until the date of death from any cause, assessed up to 3 years
title
Number of Participants According to Best Response
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice