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NCT01198067 · FLOW

Participant flow

Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia · Source last updated 2025-09-04

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

groups
  1. description
    2mg Pomolidomide per day per Cycle (Cycle = 28 days)
    id
    FG000
    title
    Cohort 2
  2. description
    1mg Pomolidomide per day per Cycle (Cycle = 28 days)
    id
    FG001
    title
    Cohort 3
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Six patients were screen failures; did not meet inclusion criteria. Original study design included Arms with assignment to increasing dose escalation including 3 and 4mg Pomolidomide Arms/Cohorts; however, safety concerns early on regarding Dose Limiting Toxicities for 2mg Cohort compelled omitting the 3 and 4mg Arms/Cohorts.
recruitment Details
Patient Eligibility:Waldenstrom relapsed,\>/18 - years old,ECOG \<\~2,Labs NCS,no prior cancers,females not preganant,\~1\> line(s) prior therapy, no therapy in 4 weeks. Excluded:pregnant, breast-feeding, serious diagnosis,chemotherapy reaction,prior pomalidomide,HIV/ Hepatitis A-C +,concurrent chemotherapy,grade\~\>2 neuropathy,andANC count \<\~1000K/ul.
Complete source fields
groups
  1. description
    2mg Pomolidomide per day per Cycle (Cycle = 28 days)
    id
    FG000
    title
    Cohort 2
  2. description
    1mg Pomolidomide per day per Cycle (Cycle = 28 days)
    id
    FG001
    title
    Cohort 3
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Six patients were screen failures; did not meet inclusion criteria. Original study design included Arms with assignment to increasing dose escalation including 3 and 4mg Pomolidomide Arms/Cohorts; however, safety concerns early on regarding Dose Limiting Toxicities for 2mg Cohort compelled omitting the 3 and 4mg Arms/Cohorts.
recruitment Details
Patient Eligibility:Waldenstrom relapsed,\>/18 - years old,ECOG \<\~2,Labs NCS,no prior cancers,females not preganant,\~1\> line(s) prior therapy, no therapy in 4 weeks. Excluded:pregnant, breast-feeding, serious diagnosis,chemotherapy reaction,prior pomalidomide,HIV/ Hepatitis A-C +,concurrent chemotherapy,grade\~\>2 neuropathy,andANC count \<\~1000K/ul.

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Preserved source evidence · Not medical advice