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NCT01349569 · FLOW

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Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission · Source last updated 2019-01-15

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

groups
  1. description
    Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle). Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed. Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
    id
    FG000
    title
    Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Two participants were screen failures. One participant withdrew consent prior to starting the study.
Complete source fields
groups
  1. description
    Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle). Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed. Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
    id
    FG000
    title
    Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Two participants were screen failures. One participant withdrew consent prior to starting the study.

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Preserved source evidence · Not medical advice