Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01849783 · ADVERSE EVENTS

Adverse events

Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma · Source last updated 2022-05-11

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
Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Other-event reporting threshold
0%

Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
D-PACE/Induction

Initial chemotherapy will consist of 1 cycle of combination D-PACE chemotherapy and peripheral blood stem cell collection.

14 / 4141 / 410 / 41
Post D-PACE/Pre-Transplant

Following D-PACE and Peripheral Blood Stem Cell (PBSC) collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days, but this may be omitted by the treating physician

2 / 418 / 410 / 41
Transplant

Transplant should preferably occur 6 weeks after the induction PACE continuous infusion has been completed, but can occur as early as 4 weeks and as late as 3 months if the participant fails to mobilize stem cells after the PACE administration

8 / 3938 / 391 / 39
Post-transplant/Consolidation

Participants will receive dexamethasone 20 mg oral days 1-4 every 21 days and thalidomide 100 mg oral and daily in the interim between transplant and consolidation. If administered, post-transplant consolidation therapy should begin 4-6 weeks after transplant, but should occur no later than 4 months after transplant. Consolidation will consist of one cycle of VDT-PACE.

4 / 388 / 380 / 38
Maintenance Therapy, Year 1

Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care

11 / 3727 / 371 / 37
Maintenance Therapy, Year 2

Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care

9 / 3122 / 310 / 31
Long Term Follow-up

Study participants will be evaluated at the study center at least once per year.

1 / 243 / 240 / 24

Group identifiers: EG000: D-PACE/Induction · EG001: Post D-PACE/Pre-Transplant · EG002: Transplant · EG003: Post-transplant/Consolidation · EG004: Maintenance Therapy, Year 1 · EG005: Maintenance Therapy, Year 2 · EG006: Long Term Follow-up

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
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Edema limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Fever
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Flu like symptoms

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
      num Events
      2
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      39
      num Events
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      31
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      39
      num Events
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      31
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
      num Events
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      31
      num Events
      3
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Cataract
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Corneal ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Eye disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Keratitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Abdominal pain
Complete source fields
description
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    41
    description
    Initial chemotherapy will consist of 1 cycle of combination D-PACE chemotherapy and peripheral blood stem cell collection.
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    41
    serious Num Affected
    14
    serious Num At Risk
    41
    title
    D-PACE/Induction
  2. deaths Num Affected
    0
    deaths Num At Risk
    41
    description
    Following D-PACE and Peripheral Blood Stem Cell (PBSC) collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days, but this may be omitted by the treating physician
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    41
    serious Num Affected
    2
    serious Num At Risk
    41
    title
    Post D-PACE/Pre-Transplant
  3. deaths Num Affected
    1
    deaths Num At Risk
    39
    description
    Transplant should preferably occur 6 weeks after the induction PACE continuous infusion has been completed, but can occur as early as 4 weeks and as late as 3 months if the participant fails to mobilize stem cells after the PACE administration
    id
    EG002
    other Num Affected
    38
    other Num At Risk
    39
    serious Num Affected
    8
    serious Num At Risk
    39
    title
    Transplant
  4. deaths Num Affected
    0
    deaths Num At Risk
    38
    description
    Participants will receive dexamethasone 20 mg oral days 1-4 every 21 days and thalidomide 100 mg oral and daily in the interim between transplant and consolidation. If administered, post-transplant consolidation therapy should begin 4-6 weeks after transplant, but should occur no later than 4 months after transplant. Consolidation will consist of one cycle of VDT-PACE.
    id
    EG003
    other Num Affected
    8
    other Num At Risk
    38
    serious Num Affected
    4
    serious Num At Risk
    38
    title
    Post-transplant/Consolidation
  5. deaths Num Affected
    1
    deaths Num At Risk
    37
    description
    Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care
    id
    EG004
    other Num Affected
    27
    other Num At Risk
    37
    serious Num Affected
    11
    serious Num At Risk
    37
    title
    Maintenance Therapy, Year 1
  6. deaths Num Affected
    0
    deaths Num At Risk
    31
    description
    Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care
    id
    EG005
    other Num Affected
    22
    other Num At Risk
    31
    serious Num Affected
    9
    serious Num At Risk
    31
    title
    Maintenance Therapy, Year 2
  7. deaths Num Affected
    0
    deaths Num At Risk
    24
    description
    Study participants will be evaluated at the study center at least once per year.
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    24
    serious Num Affected
    1
    serious Num At Risk
    24
    title
    Long Term Follow-up
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
      num Events
      2
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      39
      num Events
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      31
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      39
      num Events
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      31
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      37
      num Events
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      31
      num Events
      3
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Cataract
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Corneal ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Eye disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Keratitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      39
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      31
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Edema limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Fever
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      37
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      31
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Flu like symptoms
time Frame
Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice