Trial Outcomes & Findings for A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) (NCT NCT04272775)

Last Updated: 2020-03-17

Results Overview

DLT:Any following adverse events (AEs) possibly related to ixazomib assessed by Common Terminology Criteria for AEs (CTCAE) version 4.03; Grade 4 neutropenia/thrombocytopenia lasting \>7 consecutive days; Grade 3/greater neutropenia with fever/infections; Grade 3/greater thrombocytopenia with clinically significant bleeding; platelet count less than (\<)10,000 per cubic meter(/mm\^3); Grade 2 peripheral neuropathy with pain/Grade 3 or greater peripheral neuropathy; Grade 3/greater nonhematologic toxicities with exceptions of arthralgia/myalgia, fatigue lasting \<7 days manageable nausea/emesis with antiemetic prophylaxis, diarrhea that is controlled with supportive care; treatment delay of \>14 days at start of Cycle 2 due to failure of hematologic/nonhematologic recovery; Other Grade 2/greater ixazomib related nonhematologic toxicities required permanent discontinuation of ixazomib;Inability to receive at least 80% of planned lenalidomide doses due to the AEs related to ixazomib.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

From Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle length is equal to [=] 28 days)

Results posted on

2020-03-17

Participant Flow

Participants took part in the study at 5 investigative sites in Japan from 05 June 2012 to 15 February 2019.

Relapsed and/or refractory multiple myeloma (RRMM) participants were enrolled to receive ixazomib 4.0 milligram (mg) in: Cohort 1 and along with lenalidomide 25 milligram per day (mg/day) and dexamethasone 40 mg/day (Rd) in Cohort 2. Study was terminated after completion of Cohorts 1 and 2 due to business decision; no safety or efficacy concerns.

Participant milestones

Participant milestones
Measure	Cohort 1: Ixazomib 4.0 mg Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Overall Study STARTED	7	7
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Ixazomib 4.0 mg Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Overall Study Study Terminated by Sponsor	1	0
Overall Study Protocol Violation	0	1
Overall Study Symptomatic Deterioration	1	1
Overall Study Withdrawal by Subject	1	2
Overall Study Adverse Event	1	2
Overall Study Progressive Disease	3	1

Baseline Characteristics

A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Ixazomib 4.0 mg n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.	Total n=14 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 4.20 • n=5 Participants	60.3 years STANDARD_DEVIATION 5.82 • n=7 Participants	61.9 years STANDARD_DEVIATION 5.14 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Height	156.49 centimeter (cm) STANDARD_DEVIATION 7.932 • n=5 Participants	165.29 centimeter (cm) STANDARD_DEVIATION 8.245 • n=7 Participants	160.89 centimeter (cm) STANDARD_DEVIATION 9.015 • n=5 Participants
Weight	58.01 kilogram (kg) STANDARD_DEVIATION 8.477 • n=5 Participants	58.01 kilogram (kg) STANDARD_DEVIATION 9.688 • n=7 Participants	58.01 kilogram (kg) STANDARD_DEVIATION 8.745 • n=5 Participants
Body Surface Area (BSA)	1.585 square meter (m^2) STANDARD_DEVIATION 0.1438 • n=5 Participants	1.628 square meter (m^2) STANDARD_DEVIATION 0.1652 • n=7 Participants	1.607 square meter (m^2) STANDARD_DEVIATION 0.1504 • n=5 Participants
Eastern Cooperative Oncology Group Performance Status 0	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 1	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 2	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Medical and Surgical History Had history	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Medical and Surgical History No history	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle length is equal to [=] 28 days)

Population: The DLT analysis set consisted of DLT evaluable participants who received at least one dose of ixazomib.

Outcome measures

Outcome measures
Measure	Cohort 1: Ixazomib 4.0 mg n=6 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=6 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)

Population: The safety analysis set consisted of all participants who received at least one dose of ixazomib.

Outcome measures

Outcome measures
Measure	Cohort 1: Ixazomib 4.0 mg n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	7 Participants	7 Participants

PRIMARY outcome

Timeframe: Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)

Population: The safety analysis set consisted of all participants who received at least one dose of ixazomib.

Body weight abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).

Outcome measures

Outcome measures
Measure	Cohort 1: Ixazomib 4.0 mg n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Number of Participants With Grade 3 or Higher TEAE Related to Body Weight	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)

Population: The safety analysis set consisted of all participants who received at least one dose of ixazomib.

Vital signs were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).

Outcome measures

Outcome measures
Measure	Cohort 1: Ixazomib 4.0 mg n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Number of Participants With Grade 3 or Higher TEAE Related to Vital Signs	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)

Population: The safety analysis set consisted of all participants who received at least one dose of ixazomib.

12-lead ECGs were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).

Outcome measures

Outcome measures
Measure	Cohort 1: Ixazomib 4.0 mg n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Number of Participants With Grade 3 or Higher TEAE Related to 12-lead Electrocardiograms (ECGs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)

Population: The safety analysis set consisted of all participants who received at least one dose of ixazomib.

Laboratory tests abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).

Outcome measures

Outcome measures
Measure	Cohort 1: Ixazomib 4.0 mg n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 4: Neutrophils low	0 Participants	2 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 4: Leukocytes low	0 Participants	1 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 4: Lymphocytes low	3 Participants	0 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 4: Platelets low	3 Participants	2 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 4: Sodium low	0 Participants	1 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 4: Potassium low	0 Participants	1 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Neutrophils low	4 Participants	2 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Hemoglobin low	2 Participants	2 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Leukocytes low	3 Participants	2 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Lymphocytes low	3 Participants	3 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Platelets low	0 Participants	2 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Albumin low	1 Participants	1 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Corrected calcium high	0 Participants	1 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Sodium low	1 Participants	0 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Potassium low	1 Participants	0 Participants
Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities Grade 3: Phosphate low	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Days 1 and 15 of Cycle 1: pre-dose and at multiple time points (15, 30, 60, and 90 minutes and 2, 4, 8, 24, 48, 96, and 168 hours) post-dose (Cycle length=28 days)

Population: The pharmacokinetic (PK) analysis set consisted of all participants who received at least one dose of ixazomib and has evaluable PK data. The PK analysis set where data at specified time points was available.

Outcome measures

Outcome measures
Measure	Cohort 1: Ixazomib 4.0 mg n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Cmax: Maximum Observed Plasma Concentration for Ixazomib Day 1	65.3 nanogram per milliliter (ng/mL) Standard Deviation 54.6	32.9 nanogram per milliliter (ng/mL) Standard Deviation 19.3
Cmax: Maximum Observed Plasma Concentration for Ixazomib Day 15	68.8 nanogram per milliliter (ng/mL) Standard Deviation 59.9	34.5 nanogram per milliliter (ng/mL) Standard Deviation 42.0

SECONDARY outcome

Timeframe: Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)

Population: The response evaluable analysis set consisted of all participants who received at least one dose of ixazomib, have measurable disease at baseline, and at least one postbaseline response assessment.

Number of participants who achieved CR, PR, VGPR were assessed in accordance to International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or greater than or equal to (\>=) 90% decrease in serum M-protein with urine M-protein \<100 milligram per 24 hours (mg/24 hrs). If disease measurable only by SFLC, \>= 90% decrease in the difference between involved and uninvolved FLC levels (dFLC). PR: \>= 50% reduction of serum M-protein and \>= 90% reduction in urine M-protein or to \<200 mg/24 hrs, or a \>= 50% decrease in dFLC. A \>=50% decrease in the size of soft tissue plasmacytomas present at baseline

Outcome measures

Outcome measures
Measure	Cohort 1: Ixazomib 4.0 mg n=7 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=6 Participants Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Number of Participants Who Achieved Complete Response (CR), Very Good Partial Response (VGPR), and Partial Response (PR)	0 Participants	2 Participants

Adverse Events

Cohort 1: Ixazomib 4.0 mg

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Ixazomib 4.0 mg n=7 participants at risk Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.	Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone n=7 participants at risk Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bronchitis	14.3% 1/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypokalaemia	14.3% 1/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Retinal detachment	14.3% 1/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Thrombocytopenia	14.3% 1/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Spinal compression fracture	14.3% 1/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER