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NCT04896658 · OUTCOME

Number of Participants With Adverse Events in Dose Escalation

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
Up to 6 weeks

What was measured

Overall incidence and severity of Adverse Events in Number of Participants with Adverse Events in Dose Escalation

Analysis population: 3 patients were enrolled in Arm A, Dose Level 1. Arm A was closed due to AEs and no patients enrolled in Arm A, Dose Level 2 3 patients were enrolled in Arm B, Dose Level 1. Then 4 new patients were enrolled in Arm B, Dose Level 2. Part 2 was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate.

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

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

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Dose Level 13Not reportedNot reportedNot reportedNot reported
Arm A - Dose Level 20Not reportedNot reportedNot reportedNot reported
Arm B - Dose Level 13Not reportedNot reportedNot reportedNot reported
Arm B - Dose Level 24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
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
    units
    Participants
description
Overall incidence and severity of Adverse Events in Number of Participants with Adverse Events in Dose Escalation
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
param Type
COUNT_OF_PARTICIPANTS
population Description
3 patients were enrolled in Arm A, Dose Level 1. Arm A was closed due to AEs and no patients enrolled in Arm A, Dose Level 2 3 patients were enrolled in Arm B, Dose Level 1. Then 4 new patients were enrolled in Arm B, Dose Level 2. Part 2 was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate.
reporting Status
POSTED
time Frame
Up to 6 weeks
title
Number of Participants With Adverse Events in Dose Escalation
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice