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NCT02441686 · ADVERSE EVENTS

Adverse events

Phase II Study of Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma · Source last updated 2026-01-13

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
AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.
Other-event reporting threshold
0%

The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone - Induction Phase

Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.

8 / 4242 / 420 / 42
Lenalidomide, [Subcutaneous Bortezomib] - Maintenance Phase

Maintenance follows induction with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.

8 / 3530 / 350 / 35

Group identifiers: EG000: Lenalidomide, Subcutaneous Bortezomib, Dexamethasone - Induction Phase · EG001: Lenalidomide, [Subcutaneous Bortezomib] - Maintenance Phase

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
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Retinal vascular disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Edema limbs
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    term
    Upper respiratory infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Spinal fracture
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Muscle weakness lower limb
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Acoustic nerve disorder NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Lethargy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Peripheral sensory neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Seizure

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    term
    Acne
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Acoustic nerve disorder NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    term
    Alkaline phosphatase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Allergic reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Alopecia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    term
    Anorexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Anxiety
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      35
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    term
    Arthritis
Complete source fields
description
The analysis population is comprised of all treated participants both starting induction and starting maintenance. SAEs are defined per protocol and OAEs represent all remaining adverse events collected (any treatment attribution and any grade) reported on study case report forms. SAEs and OAEs are reported as maximum grade by toxicity type.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    42
    description
    Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days.
    id
    EG000
    other Num Affected
    42
    other Num At Risk
    42
    serious Num Affected
    8
    serious Num At Risk
    42
    title
    Lenalidomide, Subcutaneous Bortezomib, Dexamethasone - Induction Phase
  2. deaths Num Affected
    0
    deaths Num At Risk
    35
    description
    Maintenance follows induction with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
    id
    EG001
    other Num Affected
    30
    other Num At Risk
    35
    serious Num Affected
    8
    serious Num At Risk
    35
    title
    Lenalidomide, [Subcutaneous Bortezomib] - Maintenance Phase
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    term
    Acne
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Acoustic nerve disorder NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    term
    Alkaline phosphatase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Allergic reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Alopecia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    term
    Anorexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Anxiety
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      35
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    term
    Arthritis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Retinal vascular disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Edema limbs
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    term
    Upper respiratory infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Spinal fracture
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Muscle weakness lower limb
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Acoustic nerve disorder NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Lethargy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Peripheral sensory neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    term
    Seizure
time Frame
AEs were assessed for a maximum of 274 days on induction +30 days, 1071 days on maintenance +30 days.

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