Baseline characteristics

Ixazomib Citrate, Pomalidomide, Dexamethasone, Stem Cell Transplant in Treating Relapsed or Refractory Multiple Myeloma · Source last updated 2023-09-21

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

      8

   units

   Participants

groups

1. description

   INDUCTION (COURSES 1-4): Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days (courses 1-3) and 56 days (course 4) for up to 4 courses in the absence of disease progression or unacceptable toxicity.\> \> TRANSPLANTATION (COURSE 5): Between 2-4 weeks following Induction, patients undergo ASCT.\> \> CONSOLIDATION (COURSES 6-9): Beginning 60-120 days following ASCT, patients receive ixazomib citrate, pomalidomide, and dexamethasone as in Induction. Treatment repeats every 28 days (courses 6-8) and 56 days (course 9) for up to 4 courses in the absence of disease progression or unacceptable toxicity.\> \> MAINTENANCE (COURSES 10+): Beginning 0-4 weeks following Consolidation, patients receive ixazomib citrate as in Induction. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT\> \> Dexamethasone: Given PO\> \> Ixazomib Citrate: Given PO\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pomalidomide: Given PO

   id

   BG000

   title

   Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            11.17

            value

            63.5

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            7

         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

            2

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            6

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            0

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Ethnicity (NIH/OMB)

   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

            0

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            8

         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

5. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            8

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

6. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            2

         title

         Stage I

      2. measurements

         1. group Id

            BG000

            value

            5

         title

         Stage II

      3. measurements

         1. group Id

            BG000

            value

            1

         title

         Unknown

   description

   Stage I (All criteria must be met) - Serum β2 microglobulin\<3.5 mg/L; Serum albumin≥3.5 g/dL; Del(17p) and/or t(4;14) and/or t(14;16)=No; Abnormal LDH level=No Stage II - All other possible combinations (not Stage I or Stage III) Stage III (All criteria must be met) - Serum β2 microglobulin\>5.5 mg/L; Serum albumin=NA; Del(17p) and/or t(4;14) and/or t(14;16)=Yes AND/OR Abnormal LDH level=Yes The higher the stage, the worse the prognosis.

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Revised international staging system (R-ISS) myeloma stage at initial diagnosis

   unit Of Measure

   Participants

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Preserved source evidence · Not medical advice