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NCT01050790 · FLOW

Participant flow

Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma · Source last updated 2018-06-26

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

groups
  1. description
    Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
    id
    FG000
    title
    Aza Len Lymphapheresis SCT ALI
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Potential patients will be identified at the first BMT consult. They will then be preliminarily screened. If deemed eligible, they will be consented at the second BMT consult. After consent the subject will be officially screened for eligibility as described in the protocol. If eligible they will be enrolled.
Complete source fields
groups
  1. description
    Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
    id
    FG000
    title
    Aza Len Lymphapheresis SCT ALI
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Potential patients will be identified at the first BMT consult. They will then be preliminarily screened. If deemed eligible, they will be consented at the second BMT consult. After consent the subject will be officially screened for eligibility as described in the protocol. If eligible they will be enrolled.

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

Preserved source evidence · Not medical advice