Baseline characteristics

A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) · Source last updated 2018-10-16

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

      18

   units

   Participants

groups

1. description

   Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.

   id

   BG000

   title

   Daratumumab and Durvalumab

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            11.41

            value

            62.8

   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

            11

         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

            0

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            0

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            1

         title

         Black or African American

      4. measurements

         1. group Id

            BG000

            value

            15

         title

         White

      5. measurements

         1. group Id

            BG000

            value

            2

         title

         Not Collected or Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            12

         title

         0 = Fully Active

      2. measurements

         1. group Id

            BG000

            value

            5

         title

         1 = Restrictive but ambulatory

      3. measurements

         1. group Id

            BG000

            value

            1

         title

         2 = Ambulatory but unable to work

      4. measurements

         1. group Id

            BG000

            value

            0

         title

         3 = Limited Self-Care

   description

   ECOG PS is used by physicians and researchers to assess how a subject's disease is progressing, and how the disease affects the daily living activities and determine appropriate treatment and prognosis. 0 = Fully Active, able to carry on all pre-disease performance without restriction; 1 = Restricted, in physically strenuous activity but ambulatory; 2 = Ambulatory and capable of all self-care; unable to carry out work activities. 3 = Capable of only limited self-care, confined to bed or chair \>50% of waking hours 4 = Completely Disabled, cannot carry on any self-care 5 = Dead

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

   unit Of Measure

   Participants

5. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            5

         title

         Stage I

      2. measurements

         1. group Id

            BG000

            value

            4

         title

         Stage II

      3. measurements

         1. group Id

            BG000

            value

            9

         title

         Stage III

      4. measurements

         1. group Id

            BG000

            value

            0

         title

         Missing

   description

   The International Staging System divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Stage I: Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L); Stage II: Neither stage I or III, meaning that either: # The beta-2 microglobulin level is between 3.5 and 5.5 (with any albumin level), OR # The albumin is below 3.5 while the beta-2 microglobulin is less than 3.5 Stage III: Serum beta-2 microglobulin is greater than 5.5.

   param Type

   COUNT_OF_PARTICIPANTS

   title

   International Staging System Multiple Myeloma Stage at Entry

   unit Of Measure

   Participants

6. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            3

            upper Limit

            16

            value

            4.5

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Number of Prior Regimens

   unit Of Measure

   Regimens

population Description

Full Analysis Population = all participants who enrolled in the study.

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Preserved source evidence · Not medical advice