Trial Outcomes & Findings for A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM) (NCT NCT03439293)

Last Updated: 2024-07-03

Results Overview

Response was assessed using International Myeloma Working Group (IMWG) Criteria. VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours. The percentage of participants were rounded off to the single decimal point.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2024-07-03

Participant Flow

Participants took part in the study at investigative sites in Greece, the Czech Republic, the United States, Poland, France and the Netherlands from 13 March 2018 to 26 June 2023.

Participants with a diagnosis of relapsed and/or refractory multiple myeloma (RRMM) took part in the study to receive ixazomib + daratumumab + dexamethasone.

Participant milestones

Participant milestones
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Overall Study STARTED	61
Overall Study Response-evaluable Population	59
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	61

Reasons for withdrawal

Reasons for withdrawal
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Overall Study Death	22
Overall Study Withdrawal by Subject	8
Overall Study Lost to Follow-up	2
Overall Study Reason Not Specified	28
Overall Study Missing	1

Baseline Characteristics

Number analyzed is the number of participants with data available for height at Baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=61 Participants Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Age, Continuous	67.8 years STANDARD_DEVIATION 7.80 • n=61 Participants
Sex: Female, Male Female	29 Participants n=61 Participants
Sex: Female, Male Male	32 Participants n=61 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=61 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=61 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=61 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=61 Participants
Race (NIH/OMB) Asian	0 Participants n=61 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=61 Participants
Race (NIH/OMB) Black or African American	3 Participants n=61 Participants
Race (NIH/OMB) White	53 Participants n=61 Participants
Race (NIH/OMB) More than one race	0 Participants n=61 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=61 Participants
Height	166.8 centimeters (cm) STANDARD_DEVIATION 8.71 • n=60 Participants • Number analyzed is the number of participants with data available for height at Baseline.
Weight	80.08 kilograms (kg) STANDARD_DEVIATION 17.625 • n=61 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: Response-evaluable population included participants who received at least 1 dose of ixazomib, had measurable disease during the screening period, and have at least 1 postbaseline disease assessment.

Outcome measures

Outcome measures
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=59 Participants Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Percentage of Participants With Very Good Partial Response (VGPR) or Better (Complete Response + VGPR)	32.2 percentage of participants Interval 20.62 to 45.64

SECONDARY outcome

Timeframe: Up to 5 years

Population: Safety population included participants who received at least 1 dose of any study treatment regimen.

PFS is defined as time from date of first dose of drug to date of first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Participant without documentation of PD or death were censored at the date of last response assessment that is stable disease (SD) or better. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. SD is defined as not meeting criteria for other responses.

Outcome measures

Outcome measures
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=61 Participants Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Progression-free Survival (PFS)	16.8 months Interval 10.1 to 23.7

SECONDARY outcome

Timeframe: Up to 5 years

Population: Safety population included participants who received at least 1 dose of any study treatment regimen.

TTP is defined as the time from the first dose of any study drug treatment to the date of the first documented PD. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.

Outcome measures

Outcome measures
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=61 Participants Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Time to Progression (TTP)	21.1 months Interval 10.2 to 27.9

SECONDARY outcome

Timeframe: Up to 5 years

Population: Safety population included participants who received at least 1 dose of any study treatment regimen.

OS is defined as the time from the date of first dose of any study drug treatment to the date of death. Participant without documentation of death at the time of analysis will be censored at the last visit at which s/he was known to be alive.

Outcome measures

Outcome measures
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=61 Participants Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Overall Survival (OS)	NA months Median, lower and upper limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 5 years

Population: Response-evaluable population included participants who received at least 1 dose of ixazomib, had measurable disease during the screening period, and had at least 1 postbaseline disease assessment.

ORR is defined as percentage of participants with complete response (CR), VGPR and partial response (PR). CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; normal free light chain (FLC) ratio of 0.26-1.65; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24 hours; and PR: \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions. The percentage of participants were rounded off to the single decimal point.

Outcome measures

Outcome measures
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=59 Participants Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Overall Response Rate (ORR)	66.1 percentage of participants

SECONDARY outcome

Timeframe: Up to 5 years

TTR is defined as the time from first dose of any study drug treatment to the date of first documentation of PR or better. PR is defined as \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions.

Outcome measures

Outcome measures
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=59 Participants Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Time To Response (TTR)	2.7 months Interval 1.9 to 5.8

SECONDARY outcome

Timeframe: Up to 5 years

DOR is defined as the time from the date of first documentation of PR or better to the date of the first documented PD among participants who responded to the treatment.

Outcome measures

Outcome measures
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=39 Participants Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Duration of Response (DOR)	24.0 months Interval 15.9 to Upper limit of 95% CI was not estimable due to low number of responders with events.

Adverse Events

Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg

Serious events: 28 serious events

Other events: 58 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=61 participants at risk Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Renal and urinary disorders Acute kidney injury	3.3% 2/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Blood and lymphatic system disorders Anaemia	3.3% 2/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Musculoskeletal and connective tissue disorders Back pain	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Musculoskeletal and connective tissue disorders Bone pain	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Bronchitis	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations COVID-19	3.3% 2/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations COVID-19 pneumonia	4.9% 3/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Cardiac disorders Cardiovascular disorder	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Gastroenteritis	3.3% 2/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Metabolism and nutrition disorders Hypokalaemia	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Vascular disorders Hypotension	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Investigations Influenza B virus test positive	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Loss of consciousness	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Investigations Monoclonal immunoglobulin present	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Necrotising fasciitis	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Parainfluenzae virus infection	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Pneumonia	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Pneumonia herpes viral	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Pneumonia legionella	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Pneumonia respiratory syncytial viral	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Pseudomonal bacteraemia	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Gastrointestinal disorders Rectal haemorrhage	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Respiratory tract infection	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Sepsis	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Septic shock	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Spinal cord compression	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Status epilepticus	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
General disorders Sudden death	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Syncope	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Urinary tract infection	3.3% 2/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Ear and labyrinth disorders Vestibular disorder	1.6% 1/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.

Other adverse events

Other adverse events
Measure	Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg n=61 participants at risk Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Gastrointestinal disorders Abdominal pain upper	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Blood and lymphatic system disorders Anaemia	27.9% 17/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Musculoskeletal and connective tissue disorders Arthralgia	23.0% 14/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
General disorders Asthenia	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Musculoskeletal and connective tissue disorders Back pain	23.0% 14/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Musculoskeletal and connective tissue disorders Bone pain	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Bronchitis	13.1% 8/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Eye disorders Cataract	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Gastrointestinal disorders Constipation	16.4% 10/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Respiratory, thoracic and mediastinal disorders Cough	11.5% 7/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Gastrointestinal disorders Diarrhoea	42.6% 26/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Dizziness	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.4% 10/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Injury, poisoning and procedural complications Fall	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
General disorders Fatigue	24.6% 15/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Headache	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Metabolism and nutrition disorders Hyperglycaemia	11.5% 7/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Hypoaesthesia	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Metabolism and nutrition disorders Hypocalcaemia	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Metabolism and nutrition disorders Hypokalaemia	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Injury, poisoning and procedural complications Infusion related reaction	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Psychiatric disorders Insomnia	14.8% 9/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Blood and lymphatic system disorders Leukopenia	8.2% 5/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Lower respiratory tract infection	8.2% 5/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Musculoskeletal and connective tissue disorders Myalgia	8.2% 5/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Nasopharyngitis	8.2% 5/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Gastrointestinal disorders Nausea	21.3% 13/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Neuropathy peripheral	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Blood and lymphatic system disorders Neutropenia	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
General disorders Oedema peripheral	16.4% 10/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Musculoskeletal and connective tissue disorders Pain in extremity	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Peripheral sensory neuropathy	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
General disorders Peripheral swelling	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Pneumonia	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Respiratory, thoracic and mediastinal disorders Productive cough	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
General disorders Pyrexia	14.8% 9/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Skin and subcutaneous tissue disorders Rash	13.1% 8/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Nervous system disorders Somnolence	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Blood and lymphatic system disorders Thrombocytopenia	26.2% 16/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Upper respiratory tract infection	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Infections and infestations Urinary tract infection	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Ear and labyrinth disorders Vertigo	6.6% 4/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Gastrointestinal disorders Vomiting	9.8% 6/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.
Investigations White blood cell count decreased	8.2% 5/61 • Up to 5 years Safety population included participants who received at least 1 dose of any study treatment regimen.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER