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NCT01303965 · FLOW

Participant flow

Allo Transplant Followed by Lenalidomide and Sirolimus Maintenance in High-Risk Multiple Myeloma (MM) · Source last updated 2019-01-08

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

groups
  1. description
    Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
    id
    FG000
    title
    Phase I Dose Finding
  2. description
    Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
    id
    FG001
    title
    Phase II
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This protocol was a Phase I/II study. Phase I was based on a 3+3 design with the first cohort found to be safe with 3 patients. Phase II was based on a Simon Minimax two-stage design with the first interim analysis planned after 28 patients. The study was stopped at 11 patients in Phase II due to slow accrual.
Complete source fields
groups
  1. description
    Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
    id
    FG000
    title
    Phase I Dose Finding
  2. description
    Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
    id
    FG001
    title
    Phase II
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This protocol was a Phase I/II study. Phase I was based on a 3+3 design with the first cohort found to be safe with 3 patients. Phase II was based on a Simon Minimax two-stage design with the first interim analysis planned after 28 patients. The study was stopped at 11 patients in Phase II due to slow accrual.

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

Preserved source evidence · Not medical advice