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NCT02669615 · ADVERSE EVENTS

Adverse events

Pharmacokinetic Study of Propylene Glycol-Free Melphalan HCl for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation · Source last updated 2018-10-10

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
100 days post transplant
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Melphalan HCl for Injection (Propylene Glycol Free)

Patients will receive 200 mg/m\^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2. Blood samples for the pharmacokinetic (PK) evaluation of melphalan will be collected after melphalan dosing (day -2). Following one day of rest after the myeloablative Melphalan conditioning (day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (day 0). Melphalan HCl for injection (propylene glycol free): During the study period, patients will receive 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2.

0 / 2424 / 240 / 24

Group identifiers: EG000: Melphalan HCl for Injection (Propylene Glycol Free)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Myeloablation as expected
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        24
        num At Risk
        24
        num Events
        24
      term
      leukopenia
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      24
      description
      Patients will receive 200 mg/m\^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2. Blood samples for the pharmacokinetic (PK) evaluation of melphalan will be collected after melphalan dosing (day -2). Following one day of rest after the myeloablative Melphalan conditioning (day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (day 0). Melphalan HCl for injection (propylene glycol free): During the study period, patients will receive 200 mg/m2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2.
      id
      EG000
      other Num Affected
      24
      other Num At Risk
      24
      serious Num Affected
      0
      serious Num At Risk
      24
      title
      Melphalan HCl for Injection (Propylene Glycol Free)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Myeloablation as expected
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        24
        num At Risk
        24
        num Events
        24
      term
      leukopenia
    time Frame
    100 days post transplant

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

    Preserved source evidence · Not medical advice