Baseline characteristics

A Phase II Study of Carfilzomib in Relapsed Waldenström's Macroglobulinemia (WM) IST-CAR-531 · Source last updated 2026-04-03

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

      7

   units

   Participants

groups

1. description

   Carfilzomib 20 mg/m2 on day 1, 2 then 56 mg/m2 days 8, 9 and 15, 16 over 30 minutes every 28 days. Dexamethasone 4 mg (8 mg if \> 45 mg/m2) orally each day of carfilzomib therapy. If less than a partial remission (PR) after 4 cycles, add rituximab 375 mg/m2 on day 16 of each cycle. Patients who meet the criteria for progression prior to 4 cycles of therapy will have rituximab added to their treatment. For patients receiving rituximab, the carfilzomib dose will be decreased to 27 mg/m2. Patients will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles. Carfilzomib: Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study. Rituximab: If less than a partial remission (PR) after 4 cycles is achieved, rituximab 375 mg/m2 on day 16 of each subsequent cycle will be added to the treatment. Subjects who meet the criteria for progression prior to 4 cycles of therapy will have rituximab 375 mg/m2 weekly for 4 consecutive weeks every 3 cycles added to the treatment. Subjects will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles. Dexamethasone: weekly on Days 1, 2, 8, 9, 15 and 16 starting with cycle 1 and continuing every cycle thereafter.

   id

   BG000

   title

   Carfilzomib

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            4

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            3

         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

            56

            upper Limit

            67

            value

            61.5

   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

            2

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            5

         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

            6

      title

      Caucasian

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            1

      title

      African American

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

5. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            7

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

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Preserved source evidence · Not medical advice