Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01816971 · ADVERSE EVENTS

Adverse events

Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2026-04-21

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 (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years.
Other-event reporting threshold
0%

AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Dexamethasone, Carfilzomib, Lenalidomide)

INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies

27 / 7676 / 7612 / 76

Group identifiers: EG000: Treatment (Dexamethasone, Carfilzomib, Lenalidomide)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      76
      num Events
      54
    term
    serious cardiovascular events
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      76
      num Events
      10
    term
    Fever
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      76
      num Events
      4
    term
    Lung infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Non-cardiac chest pain, pleuritic
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Febrile neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Eye disorders
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Gastrointestinal disorders
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Chills
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Flu like symptoms
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      76
      num Events
      3
    term
    Upper respiratory infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Infections and infestations

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      76
      num Events
      15
    term
    Cardiac disorders
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      76
      num Events
      15
    term
    Thromboembolic events
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      76
      num Events
      23
    term
    Hypertension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      76
      num Events
      49
    term
    Hypophosphatemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      76
      num Events
      62
    term
    Rash
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      76
      num Events
      41
    term
    Peripheral neuropathy
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      76
      num Events
      47
    term
    Dyspnea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      76
      num Events
      79
    term
    Hyperglycemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      76
      num Events
      67
    term
    Diarrhea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      76
      num Events
      111
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      76
      num Events
      136
    term
    Infection
Complete source fields
description
AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Per protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    76
    description
    INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity. dexamethasone: Given IV or PO carfilzomib: Given IV lenalidomide: Given PO autologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant laboratory biomarker analysis: Correlative studies
    id
    EG000
    other Num Affected
    76
    other Num At Risk
    76
    serious Num Affected
    27
    serious Num At Risk
    76
    title
    Treatment (Dexamethasone, Carfilzomib, Lenalidomide)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      76
      num Events
      15
    term
    Cardiac disorders
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      76
      num Events
      15
    term
    Thromboembolic events
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      76
      num Events
      23
    term
    Hypertension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      76
      num Events
      49
    term
    Hypophosphatemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      76
      num Events
      62
    term
    Rash
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      76
      num Events
      41
    term
    Peripheral neuropathy
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      76
      num Events
      47
    term
    Dyspnea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      76
      num Events
      79
    term
    Hyperglycemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      76
      num Events
      67
    term
    Diarrhea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      76
      num Events
      111
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      76
      num Events
      136
    term
    Infection
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      76
      num Events
      54
    term
    serious cardiovascular events
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      76
      num Events
      10
    term
    Fever
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      76
      num Events
      4
    term
    Lung infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Non-cardiac chest pain, pleuritic
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Febrile neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Eye disorders
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Gastrointestinal disorders
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Chills
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Flu like symptoms
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      76
      num Events
      3
    term
    Upper respiratory infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI V4.01
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Infections and infestations
time Frame
adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years.

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

Preserved source evidence · Not medical advice