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NCT01421186 · OUTCOME

Number of Participants Who Develop Anti-MOR03087 Antibodies

A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma · Source last updated 2021-11-16

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
during treatment period, maximum 3 years after 1st dose

What was measured

Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity

Analysis population: all patients with available data

Groups in this outcome

Part A: MOR03087 Biweekly Dose Escalation

Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg

Part B: MOR03087 Weekly Dose Escalation

Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg

Part C: MOR03087 Plus Dexamethasone

Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)

Part D: MOR03087 Plus Pomalidomide + Dexamethasone

Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.

Part E: MOR03087 Plus Lenalidomide + Dexamethasone

Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Part A: MOR03087 Biweekly Dose Escalation31
Part B: MOR03087 Weekly Dose Escalation4
Part C: MOR03087 Plus Dexamethasone18
Part D: MOR03087 Plus Pomalidomide + Dexamethasone21
Part E: MOR03087 Plus Lenalidomide + Dexamethasone17

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: MOR03087 Biweekly Dose Escalation0Not reportedNot reportedNot reportedNot reported
Part B: MOR03087 Weekly Dose Escalation0Not reportedNot reportedNot reportedNot reported
Part C: MOR03087 Plus Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part D: MOR03087 Plus Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part E: MOR03087 Plus Lenalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      18
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      17
    units
    Participants
description
Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity
groups
  1. description
    Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
    id
    OG000
    title
    Part A: MOR03087 Biweekly Dose Escalation
  2. description
    Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
    id
    OG001
    title
    Part B: MOR03087 Weekly Dose Escalation
  3. description
    Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
    id
    OG002
    title
    Part C: MOR03087 Plus Dexamethasone
  4. description
    Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
    id
    OG003
    title
    Part D: MOR03087 Plus Pomalidomide + Dexamethasone
  5. description
    Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
    id
    OG004
    title
    Part E: MOR03087 Plus Lenalidomide + Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
all patients with available data
reporting Status
POSTED
time Frame
during treatment period, maximum 3 years after 1st dose
title
Number of Participants Who Develop Anti-MOR03087 Antibodies
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice