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NCT01421186 · OUTCOME

Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087

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
NUMBER
Unit
mg/kg
Interval / dispersion
Not reported
Time frame
First cycle of treatment

What was measured

1. as monotherapy 2. in combination with dexamethasone 3. in combination with pomalidomide + dexamethasone 4. in combination with lenalidomide + dexamethasone

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 mg/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: MOR03087 Biweekly Dose Escalation16Not reportedNot reportedNot reportedNot reported
Part B: MOR03087 Weekly Dose Escalation16Not reportedNot reportedNot reportedNot reported
Part C: MOR03087 Plus Dexamethasone16Not reportedNot reportedNot reportedNot reported
Part D: MOR03087 Plus Pomalidomide + Dexamethasone16Not reportedNot reportedNot reportedNot reported
Part E: MOR03087 Plus Lenalidomide + Dexamethasone16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        16
      5. group Id
        OG004
        value
        16
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
1. as monotherapy 2. in combination with dexamethasone 3. in combination with pomalidomide + dexamethasone 4. in combination with lenalidomide + dexamethasone
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
NUMBER
reporting Status
POSTED
time Frame
First cycle of treatment
title
Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087
type
PRIMARY
unit Of Measure
mg/kg

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Preserved source evidence · Not medical advice