Baseline characteristics

A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma · Source last updated 2018-02-13

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

      13

   units

   Participants

groups

1. description

   Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.

   id

   BG000

   title

   Ruxolitinib Then Ruxolitinib + Dexamethasone

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            8.36

            value

            74.7

   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

            5

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            8

         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

            3

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            10

         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

   description

   Stage I: Relatively few cancer cells have spread throughout the body. Levels of red blood cells and calcium in the blood are normal. No bone tumors. M-protein in the blood or urine is very low. Possibly no symptoms of disease. Stage II: A moderate number of cancer cells have spread throughout the body. Stage III: A large number of cancer cells have spread throughout the body. There may be 1 or more of the following: * Decreased red blood cells, causing anemia * High amounts of calcium in the blood * More than 3 bone tumors (plasmacytomas) * High levels of M-protein in blood or urine

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

      title

      I

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            4

      title

      II

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            4

      title

      III

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            5

      title

      Unknown

   param Type

   NUMBER

   title

   Stage of multiple myeloma at initial diagnosis

   unit Of Measure

   participants

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Preserved source evidence · Not medical advice