NCT04140162 · ADVERSE EVENTS

Adverse events

Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy · Source last updated 2026-07-28

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: Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dara-Rd Followed by Dara-RVd * Induction regimen with Dara-Rd in all study subjects, weeks 1-24 * Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36 * Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88 * Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses). Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab. Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly	25 / 56	56 / 56	5 / 56

Group identifiers: EG000: Dara-Rd Followed by Dara-RVd

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
56
num Events
3
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Perforation of gastrojejunostomy
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Gastrointestinal disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cat Bite
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Infections and infestations - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
COVID-19
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Infections and infestations - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Suspected Cellulitis Diagnosis: Hidradenitis Suppurativa of the upper bilateral thighs
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Infections and infestations - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
56
num Events
4
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Pseudo-gout
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Musculoskeletal and connective tissue disorder - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
5
num At Risk
56
num Events
5
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
2
term
Skin infection

Other reported adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
56
num Events
3
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
13
num At Risk
56
num Events
14
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
5
num At Risk
56
num Events
6
term
Agitation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
56
num Events
4
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
5
num At Risk
56
num Events
6
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
6
num At Risk
56
num Events
6
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
11
num At Risk
56
num Events
36
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
9
num At Risk
56
num Events
11
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
56
num Events
7
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
10
num At Risk
56
num Events
13
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
56
num Events
8
term
Arthritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
56
num Events
3
term
Aspartate aminotransferase increased

Complete source fields

event Groups

deaths Num Affected
5
deaths Num At Risk
56
description
* Induction regimen with Dara-Rd in all study subjects, weeks 1-24 * Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36 * Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88 * Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses). Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab. Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
id
EG000
other Num Affected
56
other Num At Risk
56
serious Num Affected
25
serious Num At Risk
56
title
Dara-Rd Followed by Dara-RVd

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
56
num Events
3
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
13
num At Risk
56
num Events
14
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
5
num At Risk
56
num Events
6
term
Agitation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
56
num Events
4
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
5
num At Risk
56
num Events
6
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
6
num At Risk
56
num Events
6
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
11
num At Risk
56
num Events
36
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
9
num At Risk
56
num Events
11
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
56
num Events
7
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
10
num At Risk
56
num Events
13
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
56
num Events
8
term
Arthritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
56
num Events
3
term
Aspartate aminotransferase increased

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
56
num Events
3
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Perforation of gastrojejunostomy
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Gastrointestinal disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cat Bite
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Infections and infestations - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
COVID-19
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Infections and infestations - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Suspected Cellulitis Diagnosis: Hidradenitis Suppurativa of the upper bilateral thighs
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Infections and infestations - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
56
num Events
4
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Pseudo-gout
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
1
term
Musculoskeletal and connective tissue disorder - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
5
num At Risk
56
num Events
5
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
56
num Events
2
term
Skin infection

time Frame

Events are still being collected, events currently are reported through 4 years. All AEs are combined, regardless of phase of study, per protocol, as subjects followed the appropriate treatment pathway. Data by phase is not available as the protocol did not mandate the collection be separated by phase of study.

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Preserved source evidence · Independent clinical review pending · Not medical advice