Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01421186 · OUTCOME

Duration of Response

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
patients were observed up to 36 months

What was measured

Duration of response (Kaplan Meier estimates)

Analysis population: Of the total 91 patients, 26 obtained a response: 5 in part C, 10 in part D and 11 in part E. Duration of response was calculated only in these patients.

Groups in this outcome

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 C: MOR03087 Plus Dexamethasone5
Part D: MOR03087 Plus Pomalidomide + Dexamethasone10
Part E: MOR03087 Plus Lenalidomide + Dexamethasone11

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part C: MOR03087 Plus Dexamethasone16.7Not reported1.9NAUpper confidence limit could not be estimated due to low number of patients with an event.
Part D: MOR03087 Plus Pomalidomide + Dexamethasone21.2Not reported9.2NAUpper confidence limit could not be estimated due to low number of patients with an event.
Part E: MOR03087 Plus Lenalidomide + Dexamethasone32.2Not reported4.2NAUpper confidence limit could not be estimated due to low number of patients with an event.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper confidence limit could not be estimated due to low number of patients with an event.
        group Id
        OG000
        lower Limit
        1.9
        upper Limit
        NA
        value
        16.7
      2. comment
        Upper confidence limit could not be estimated due to low number of patients with an event.
        group Id
        OG001
        lower Limit
        9.2
        upper Limit
        NA
        value
        21.2
      3. comment
        Upper confidence limit could not be estimated due to low number of patients with an event.
        group Id
        OG002
        lower Limit
        4.2
        upper Limit
        NA
        value
        32.2
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      11
    units
    Participants
description
Duration of response (Kaplan Meier estimates)
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Part C: MOR03087 Plus Dexamethasone
  2. 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
    OG001
    title
    Part D: MOR03087 Plus Pomalidomide + Dexamethasone
  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 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
    OG002
    title
    Part E: MOR03087 Plus Lenalidomide + Dexamethasone
param Type
MEDIAN
population Description
Of the total 91 patients, 26 obtained a response: 5 in part C, 10 in part D and 11 in part E. Duration of response was calculated only in these patients.
reporting Status
POSTED
time Frame
patients were observed up to 36 months
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice