Baseline characteristics

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.

denoms

1. counts

   1. group Id

      BG000

      value

      24

   units

   Participants

groups

1. description

   Patients will receive 200 mg/m2 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

   BG000

   title

   Melphalan HCl for Injection (Propylene Glycol Free)

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            11

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            13

         title

         >=65 years

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Age, Categorical

   unit Of Measure

   Participants

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            46

            upper Limit

            72

            value

            67

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Age, Continuous

   unit Of Measure

   years

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            9

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            15

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            0

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            0

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            5

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            19

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            0

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            0

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

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Preserved source evidence · Not medical advice