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NCT01146834 · ADVERSE EVENTS

Adverse events

Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma · Source last updated 2019-12-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Other-event reporting threshold
0%

Arm D and Arm E did not enrolled any patients

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF

VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)

0 / 208 / 200 / 20
Arm B: VELCADE & G-CSF

VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)

0 / 44 / 40 / 4
Arm C: CYCLOPHOSPHAMIDE & G-CSF

High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)

1 / 2318 / 230 / 23
Arm D: PLERIXAFOR & G-CSF

G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status. G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)

0 / 00 / 00 / 0
Arm E: PLERIXAFOR, VELCADE, & G-CSF

Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)

0 / 00 / 00 / 0

Group identifiers: EG000: Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF · EG001: Arm B: VELCADE & G-CSF · EG002: Arm C: CYCLOPHOSPHAMIDE & G-CSF · EG003: Arm D: PLERIXAFOR & G-CSF · EG004: Arm E: PLERIXAFOR, VELCADE, & G-CSF

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Febrile Neutropenia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Hypocalcemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    back pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    White blood cell count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Platelet count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    hypoglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Hypokalemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Hypomagnesemia
Complete source fields
description
Arm D and Arm E did not enrolled any patients
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    20
    description
    VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    20
    serious Num Affected
    0
    serious Num At Risk
    20
    title
    Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
  2. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Arm B: VELCADE & G-CSF
  3. deaths Num Affected
    0
    deaths Num At Risk
    23
    description
    High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
    id
    EG002
    other Num Affected
    18
    other Num At Risk
    23
    serious Num Affected
    1
    serious Num At Risk
    23
    title
    Arm C: CYCLOPHOSPHAMIDE & G-CSF
  4. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status. G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Arm D: PLERIXAFOR & G-CSF
  5. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Arm E: PLERIXAFOR, VELCADE, & G-CSF
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Hypocalcemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    back pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    White blood cell count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Platelet count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    hypoglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Hypokalemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Hypomagnesemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      23
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
    term
    Febrile Neutropenia
time Frame
Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.

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Preserved source evidence · Not medical advice