Participant flow

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy · Source last updated 2026-06-02

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

groups

1. description

   Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.

   id

   FG000

   title

   Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)

2. description

   Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.

   id

   FG001

   title

   Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         50

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         11

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Randomized but not treated

   5. reasons

      1. group Id

         FG000

         num Subjects

         126

      2. group Id

         FG001

         num Subjects

         135

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         198

      2. group Id

         FG001

         num Subjects

         197

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         195

      2. group Id

         FG001

         num Subjects

         197

      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

         198

      2. group Id

         FG001

         num Subjects

         197

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice