Baseline characteristics

MEDI-551 as Maintenance Therapy After Allogeneic Stem Cell Transplant in Multiple Myeloma · Source last updated 2019-01-14

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

      1

   units

   Participants

groups

1. description

   Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons. MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV

   id

   BG000

   title

   MEDI-551 Treatment Arm

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            1

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            0

         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

            value

            1

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            0

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. 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

            0

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            1

         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

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            1

      title

      United States

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Region of Enrollment

   unit Of Measure

   Participants

population Description

1 participant was enrolled but did not receive study treatment, however, Baseline Characteristics data were collected from the participant after enrollment

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Preserved source evidence · Not medical advice