Participant flow

Phase II Study of Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma · Source last updated 2026-01-13

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

groups

1. description

   Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.

   id

   FG000

   title

   Lenalidomide, Subcutaneous Bortezomib, Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Complicating disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Did not receive treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         46

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         42

      type

      Safety

   3. achievements

      1. group Id

         FG000

         num Subjects

         41

      type

      Progression-free Survival Evaluable

   4. achievements

      1. group Id

         FG000

         num Subjects

         40

      type

      Evaluable for Induction Response

   5. achievements

      1. group Id

         FG000

         num Subjects

         15

      type

      Received Autologous Stem Cell Transplant (ASCT)

   6. achievements

      1. group Id

         FG000

         num Subjects

         38

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         8

      type

      NOT COMPLETED

   title

   Induction

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         23

      type

      Remaining on Treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         10

      type

      Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         38

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         35

      type

      Safety

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      comment

      Given treatment duration is not a fixed duration, all participants are considered as 'Not Completed'. Reasons off-treatment are provided for all participants not still on treatment as of the date of data extraction.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         38

      type

      NOT COMPLETED

   title

   Maintenance

recruitment Details

Participants were enrolled from December 2015 to June 2017.

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

Preserved source evidence · Not medical advice