Baseline characteristics

Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma · Source last updated 2023-11-24

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

      123

   2. group Id

      BG001

      value

      0

   3. group Id

      BG002

      value

      123

   units

   Participants

groups

1. description

   Cycle 1-Dexamethasone 40mg orally days 1/8/15/22; Lenalidomide 25mg orally days 1-21; Carfilzomib 20mg/m2 days 8/9 then 36mg/m2 venous days 15/16; Daratumumab 16mg/kg venous days 1/8/15/22 (KRd-Dara). Cycle 2 the same except Carfilzomib 36mg/m2 venous days 1/2/8/9/15/16. Cycles 3,4 the same but no Daratumumab Days 8 and 22. Dosage adjusted for last tolerated dose (LTD). Following induction therapy, auto-HCT is done (consolidation 1), then up to two 4-cycle blocks of KRd-Dara consolidation (consolidations 2 and 3). Minimum residual disease (MRD) checked after each phase. Patients with confirmed MRD(-) at or after consolidation 1 will not undergo maintenance and will be actively monitored for resurgence of MRD or clinical relapse. After consolidation if MRD+ patients will undergo standard of care lenalidomide maintenance. KRdD followed by auto-HCT: Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will be followed by autologous hematopoietic cell transplantation and KRdD consolidation.

   id

   BG000

   title

   KRdD Followed by Auto-HCT

2. description

   Cycle 1-Dexamethasone 40mg orally days 1/8/15/22; Lenalidomide 25mg orally days 1-21; Carfilzomib 20mg/m2 days 8/9 then @ 36mg/m2 venous days 15/16; Daratumumab 16mg/kg venous days 1/8/15/22. Cycle 2 the same except Carfilzomib 36mg/m2 venous days 1/2/8/9/15/16. Cycles 3,4 the same but no Daratumumab Day 22. Dosage adjusted for last tolerated dose (LTD). Following induction therapy, Following induction therapy, patients will receive up to three 4-cycle blocks of KRd-Dara consolidation (consolidations 1, 2 and 3). Minimum residual disease (MRD) checked after each phase. Patients with confirmed MRD(-) at or after consolidation 1 will not undergo maintenance and will be actively monitored for resurgence of MRD or clinical relapse. After consolidation if MRD+ patients will undergo standard of care lenalidomide maintenance. KRdD only: Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will not be followed by autologous hematopoietic cell transplantation but will proceed with KRdD consolidation.

   id

   BG001

   title

   KRdD Only

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            55

            upper Limit

            68

            value

            61

         2. group Id

            BG002

            lower Limit

            55

            upper Limit

            68

            value

            61

   dispersion Type

   INTER_QUARTILE_RANGE

   param Type

   MEDIAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            53

         2. group Id

            BG002

            value

            53

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            70

         2. group Id

            BG002

            value

            70

         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

         2. group Id

            BG002

            value

            0

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            2

         2. group Id

            BG002

            value

            2

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG002

            value

            0

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            25

         2. group Id

            BG002

            value

            25

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            94

         2. group Id

            BG002

            value

            94

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            2

         2. group Id

            BG002

            value

            2

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG002

            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

            123

         2. group Id

            BG002

            value

            123

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

population Description

All enrolling patients

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Preserved source evidence · Not medical advice