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NCT03301220 · BASELINE

Baseline characteristics

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma · Source last updated 2026-06-08

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
      196
    2. group Id
      BG001
      value
      194
    3. group Id
      BG002
      value
      390
    units
    Participants
groups
  1. description
    Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.
    id
    BG000
    title
    Arm A: Active Monitoring (ACTM)
  2. description
    Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).
    id
    BG001
    title
    Arm B: Daratumumab SC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.76
          value
          63.0
        2. group Id
          BG001
          spread
          11.17
          value
          61.9
        3. group Id
          BG002
          spread
          10.97
          value
          62.4
    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
          103
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          202
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          188
        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
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          169
        3. group Id
          BG002
          value
          345
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
        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
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          31
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          323
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
        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
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      Belgium
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Germany
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
      title
      Netherlands
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          57
      title
      United States
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Argentina
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
      title
      Australia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
      title
      Brazil
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
      title
      Canada
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      title
      Czech Republic
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Denmark
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
      title
      Greece
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      196
    2. group Id
      BG001
      value
      194
    3. group Id
      BG002
      value
      390
    units
    Participants
groups
  1. description
    Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.
    id
    BG000
    title
    Arm A: Active Monitoring (ACTM)
  2. description
    Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).
    id
    BG001
    title
    Arm B: Daratumumab SC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.76
          value
          63.0
        2. group Id
          BG001
          spread
          11.17
          value
          61.9
        3. group Id
          BG002
          spread
          10.97
          value
          62.4
    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
          103
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          202
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          188
        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
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          169
        3. group Id
          BG002
          value
          345
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
        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
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          31
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          323
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
        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
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      Belgium
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Germany
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
      title
      Netherlands
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          57
      title
      United States
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Argentina
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
      title
      Australia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
      title
      Brazil
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
      title
      Canada
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      title
      Czech Republic
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Denmark
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
      title
      Greece
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice