Participant flow

A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant · Source last updated 2026-06-23

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) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.

   id

   FG000

   title

   Daratumumab + Lenalidomide

2. description

   Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.

   id

   FG001

   title

   Lenalidomide

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         11

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         84

      2. group Id

         FG001

         num Subjects

         73

      type

      Ongoing

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Randomized but not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         99

      2. group Id

         FG001

         num Subjects

         101

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         96

      2. group Id

         FG001

         num Subjects

         98

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         10

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         94

      2. group Id

         FG001

         num Subjects

         91

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Currently, results posted till interim data cutoff date of 04-April-2024 (primary completion date).

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

Preserved source evidence · Not medical advice