Participant flow

Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma · Source last updated 2023-06-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Treatment was given in 28-day cycles in an outpatient treatment setting. * Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle * Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years) * Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7

   id

   FG000

   title

   Arm A (Melflufen+Dexamethasone+Daratumumab)

2. description

   Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7

   id

   FG001

   title

   Arm B (Daratumumab)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         12

      type

      Progressive Disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         10

      type

      Study Terminated by Sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Patient Request

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Failed Criteria for Treatment Initiation

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         27

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         26

      comment

      There were 6 randomized patients (5 in Arm A and 1 in Arm B) who never received treatment due to failure to meet treatment initiation criteria and/or consent withdrawal.

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         27

      type

      NOT COMPLETED

   title

   Arm A/Arm B Treatment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. comment

         There were 2 patients in Arm B who crossed over and received Melflufen+Dexamethasone+Daratumumab after a confirmed disease progression and received at least one dose of treatment.

         group Id

         FG001

         num Subjects

         2

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Crossover (Arm B)

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Preserved source evidence · Not medical advice