Participant flow

Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma · Source last updated 2026-08-04

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

groups

1. description

   Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

   id

   FG000

   title

   Arm A (Lenalidomide; Phase II)

2. description

   Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

   id

   FG001

   title

   Arm A (Lenalidomide; Phase III)

3. description

   Patients undergo observation until progression to symptomatic myeloma.

   id

   FG002

   title

   Arm B (Observation; Phase III)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         0

      type

      Lack of Efficacy

   2. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         18

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         6

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Noncompliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Other complicating disease

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Alternative therapy

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Changed hospital

   10. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          2

       3. group Id

          FG002

          num Subjects

          0

       type

       Never started treatment

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       3. group Id

          FG002

          num Subjects

          0

       type

       Reason not reported

   12. reasons

       1. group Id

          FG000

          num Subjects

          9

       2. group Id

          FG001

          num Subjects

          43

       3. group Id

          FG002

          num Subjects

          0

       type

       Continuing lenalidomide

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         90

      3. group Id

         FG002

         num Subjects

         92

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         88

      3. group Id

         FG002

         num Subjects

         86

      type

      Received Treatment/Observation

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         86

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         90

      3. group Id

         FG002

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Between January 2011 and January 2013, 44 patients were enrolled in the phase II safety run in portion of the study and were treated with lenalidomide as a single agent. Between February 2013 and July 2017, 182 patients were randomly assigned between the two treatment arms in the phase III portion of the study.

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Preserved source evidence · Not medical advice