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NCT04430894 · BASELINE

Baseline characteristics

KRDI in Transplant-Eligible MM · Source last updated 2026-06-03

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
      50
    units
    Participants
groups
  1. description
    All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.) For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation). For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles. Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only). Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
    id
    BG000
    title
    Induction
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          70
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        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
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          44
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        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
          28
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      III
    description
    The International Staging System (ISS) for multiple myeloma predicts the severity of multiple myeloma based on routinely obtained lab values (serum beta-2 microglobulin and serum albumin), with severity increasing from Stage I to Stage III. Stage I: serum beta-2 microglobulin less than 3.5 mg/L and serum albumin greater than or equal to 3.5 g/dL. Stage II: serum beta-2 microglobulin less than 3.5 mg/L and serum albumin less than 3.5 g/dL, OR beta-2 microglobulin 3.5 to 5.5 mg/L, irrespective of serum albumin. Stage III: serum beta-2 microglobulin greater than 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Stage at Diagnosis
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      III
    description
    The Revised International Staging System (R-ISS) predicts the severity of myeloma, with severity increasing from Stage I to III. I: serum beta-2 microglobulin less than 3.5 mg/L, serum albumin greater than or equal to 3.5 g/dL, no high-risk chromosomal abnormalities (CA)\* by fluorescence in-situ hybridization (FISH), normal lactate dehydrogenase (LDH) II: does not meet criteria for R-ISS Stage I or III. III: serum beta-2 microglobulin greater than or equal to than 5.5 mg/L AND high-risk CA\* by FISH OR high LDH \*High risk CAs: del(17p), translocation t(4;14), translocation t(14;16)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Revised ISS Stage at Diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      1
    description
    ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Grade 0: Fully active, able to carry on all pre-disease performance without restriction Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      No
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Unknown
    description
    High risk cytogenetics defined as deletion 17p, gain of 1q, and translocations t(4:14), t(14;16), and/or t(14;20).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    High Risk Cytogenetics
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Light-chain only
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Heavy Light Chain
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      50
    units
    Participants
groups
  1. description
    All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.) For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation). For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles. Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only). Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
    id
    BG000
    title
    Induction
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          70
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        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
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          44
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        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
          28
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      III
    description
    The International Staging System (ISS) for multiple myeloma predicts the severity of multiple myeloma based on routinely obtained lab values (serum beta-2 microglobulin and serum albumin), with severity increasing from Stage I to Stage III. Stage I: serum beta-2 microglobulin less than 3.5 mg/L and serum albumin greater than or equal to 3.5 g/dL. Stage II: serum beta-2 microglobulin less than 3.5 mg/L and serum albumin less than 3.5 g/dL, OR beta-2 microglobulin 3.5 to 5.5 mg/L, irrespective of serum albumin. Stage III: serum beta-2 microglobulin greater than 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Stage at Diagnosis
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      III
    description
    The Revised International Staging System (R-ISS) predicts the severity of myeloma, with severity increasing from Stage I to III. I: serum beta-2 microglobulin less than 3.5 mg/L, serum albumin greater than or equal to 3.5 g/dL, no high-risk chromosomal abnormalities (CA)\* by fluorescence in-situ hybridization (FISH), normal lactate dehydrogenase (LDH) II: does not meet criteria for R-ISS Stage I or III. III: serum beta-2 microglobulin greater than or equal to than 5.5 mg/L AND high-risk CA\* by FISH OR high LDH \*High risk CAs: del(17p), translocation t(4;14), translocation t(14;16)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Revised ISS Stage at Diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      1
    description
    ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Grade 0: Fully active, able to carry on all pre-disease performance without restriction Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      No
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Unknown
    description
    High risk cytogenetics defined as deletion 17p, gain of 1q, and translocations t(4:14), t(14;16), and/or t(14;20).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    High Risk Cytogenetics
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Light-chain only
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Heavy Light Chain
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice