Participant flow

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens · Source last updated 2025-04-29

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

groups

1. description

   Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m\^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.

   id

   FG000

   title

   Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)

2. description

   Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m\^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m\^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m\^2 orally on Days 1 to 4 of cycles 1 to 9.

   id

   FG001

   title

   D + Bortezomib + Melphalan + Prednisone (D-VMP)

3. description

   Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.

   id

   FG002

   title

   Daratumumab + Lenalidomide + Dexamethasone (D-Rd)

4. description

   Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m\^2 IV on Day 1 of Cycle 1 only, then 70 mg/m\^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.

   id

   FG003

   title

   Daratumumab + Carfilzomib + Dexamethasone (D-Kd)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Lost to Follow-up

   2. reasons

      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

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         5

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         5

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         41

      4. group Id

         FG003

         num Subjects

         40

      type

      Data collection ended

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         67

      2. group Id

         FG001

         num Subjects

         67

      3. group Id

         FG002

         num Subjects

         65

      4. group Id

         FG003

         num Subjects

         66

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         66

      2. group Id

         FG001

         num Subjects

         19

      3. group Id

         FG002

         num Subjects

         14

      4. group Id

         FG003

         num Subjects

         15

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         48

      3. group Id

         FG002

         num Subjects

         51

      4. group Id

         FG003

         num Subjects

         51

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice