Participant flow

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.

groups

1. description

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

   id

   FG000

   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

   FG001

   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

   FG002

   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 4 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

   FG003

   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 4 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

   FG004

   title

   Part E: MOR03087 Plus Lenalidomide + Dexamethasone

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         21

      5. group Id

         FG004

         num Subjects

         17

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         21

      5. group Id

         FG004

         num Subjects

         17

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice