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Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma (BOSTON)

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ClinicalTrials.gov Identifier: NCT03110562
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Results First Posted : July 8, 2021
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Selinexor
Drug: Bortezomib
Drug: Dexamethasone
Enrollment 402
Recruitment Details The study was conducted at 165 sites in 21 countries.
Pre-assignment Details A total of 402 participants were enrolled, out of which 399 participants received study treatment. Based on progressive disease (PD) confirmed by the Independent Review Committee (IRC), participants in the Vd arm could crossover to a regimen that included selinexor: 1) SVd treatment (SVdX) for participants who tolerated bortezomib, or 2) SdX for participants who had significant tolerability issues with bortezomib. Data reported were based on primary analysis cut-off date (18-Feb-2020).
Arm/Group Title SVd Arm: Selinexor + Bortezomib + Dexamethasone Vd Arm: Bortezomib + Dexamethasone
Hide Arm/Group Description Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. Participants received SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by greater than or equal to (>=) 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
Period Title: Overall Study
Started 195 207
Treated 195 204
Completed 0 0
Not Completed 195 207
Reason Not Completed
Withdrawal by Subject             37             35
Death             47             61
Lost to Follow-up             7             6
Other             2             1
Randomized but never treated             0             3
Ongoing             102             101
Arm/Group Title SVd Arm: Selinexor + Bortezomib + Dexamethasone Vd Arm: Bortezomib + Dexamethasone Total
Hide Arm/Group Description Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. Participants received SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. Total of all reporting groups
Overall Number of Baseline Participants 195 207 402
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 195 participants 207 participants 402 participants
65.3  (9.56) 66.7  (9.35) 66.0  (9.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 207 participants 402 participants
Female
80
  41.0%
92
  44.4%
172
  42.8%
Male
115
  59.0%
115
  55.6%
230
  57.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 195 participants 207 participants 402 participants
Asian
25
  12.8%
25
  12.1%
50
  12.4%
Black or African American
4
   2.1%
7
   3.4%
11
   2.7%
White
161
  82.6%
165
  79.7%
326
  81.1%
Other
0
   0.0%
1
   0.5%
1
   0.2%
Missing
5
   2.6%
9
   4.3%
14
   3.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 195 participants 207 participants 402 participants
Hispanic or Latino
6
   3.1%
5
   2.4%
11
   2.7%
Not Hispanic or Latino
171
  87.7%
188
  90.8%
359
  89.3%
Not Reported
14
   7.2%
11
   5.3%
25
   6.2%
Unknown
4
   2.1%
2
   1.0%
6
   1.5%
Missing
0
   0.0%
1
   0.5%
1
   0.2%
1.Primary Outcome
Title Progression-free Survival (PFS) as Assessed by IRC
Hide Description PFS was defined as time from date of randomization until the first date of IRC-confirmed PD, per International Myeloma Working Group (IMWG) response criteria, or death due to any cause, whichever occurs first. PD included increase of 25% from lowest confirmed response value in 1 or more of the following criteria: a) serum M-protein with absolute increase of >= 0.5 gram per deciliter (g/dL); b) serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; c) urine M-protein (absolute increase must be >= 200 mg per 24 hours); d) in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [>] 10 mg/dL); e) in participants without measurable serum and urine M-protein levels and without measurable involved FLC levels: bone marrow plasma cell percentage irrespective of baseline status (absolute increase must be >=10%).
Time Frame From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 32 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title SVd Arm: Selinexor + Bortezomib + Dexamethasone Vd Arm: Bortezomib + Dexamethasone
Hide Arm/Group Description:
Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
Participants received SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
Overall Number of Participants Analyzed 80 124
Median (95% Confidence Interval)
Unit of Measure: Months
13.93 [1] 
(11.73 to NA)
9.46
(8.11 to 10.78)
[1]
Upper limit of 95% CI was not estimable due to low number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SVd Arm: Selinexor + Bortezomib + Dexamethasone, Vd Arm: Bortezomib + Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments [Not Specified]
Method Stratified Log-rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.7020
Confidence Interval (2-Sided) 95%
0.5279 to 0.9335
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response Rate (ORR) as Assessed by IRC
Hide Description [Not Specified]
Time Frame From date of randomization until disease progression or death, whichever occurred first (maximum duration up to 75 months)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Percentage of Participants With Response Rates
Hide Description [Not Specified]
Time Frame From date of randomization until disease progression or death, whichever occurred first (maximum duration up to 75 months)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame From date of randomization to the date of death or censored date, whichever occurred first (maximum duration of 75 months)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Duration of Response (DOR) as Assessed by IRC
Hide Description [Not Specified]
Time Frame From the first documentation of response to the first documentation of PD or death or censored date, whichever occurred first (maximum duration up to 75 months)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time-to-next-treatment (TTNT)
Hide Description [Not Specified]
Time Frame From date of randomization to start of next anti-MM treatment or death, whichever occurs first (maximum duration of 75 months)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time-to-response (TTR) as Assessed by IRC
Hide Description [Not Specified]
Time Frame From date of randomization until the date of first IRC confirmed response (maximum duration up to 75 months)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Number of Participants With Grade >= 2 Peripheral Neuropathy Events
Hide Description [Not Specified]
Time Frame From date of randomization up to 30 days after last dose of treatment (maximum duration of 75 months)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Hide Description [Not Specified]
Time Frame From date of randomization up to 30 days after last dose of treatment (maximum duration up to 75 months)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Patient-reported Peripheral Neuropathy Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 Instrument
Hide Description [Not Specified]
Time Frame Up to 75 months
Outcome Measure Data Not Reported
Time Frame From date of randomization up to 30 days after last dose of treatment (up to 32 months )
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SVd Arm: Selinexor + Bortezomib + Dexamethasone Vd Arm: Bortezomib + Dexamethasone
Hide Arm/Group Description Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death or sponsor decision to terminate the study. Participants received SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death or sponsor decision to terminate the study.
All-Cause Mortality
SVd Arm: Selinexor + Bortezomib + Dexamethasone Vd Arm: Bortezomib + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   47/195 (24.10%)   61/204 (29.90%) 
Hide Serious Adverse Events
SVd Arm: Selinexor + Bortezomib + Dexamethasone Vd Arm: Bortezomib + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   101/195 (51.79%)   77/204 (37.75%) 
Blood and lymphatic system disorders     
Anaemia * 1  5/195 (2.56%)  3/204 (1.47%) 
Thrombocytopenia * 1  3/195 (1.54%)  1/204 (0.49%) 
Febrile neutropenia * 1  1/195 (0.51%)  1/204 (0.49%) 
Neutropenia * 1  1/195 (0.51%)  0/204 (0.00%) 
Cardiac disorders     
Atrial fibrillation * 1  4/195 (2.05%)  2/204 (0.98%) 
Cardiac failure congestive * 1  1/195 (0.51%)  1/204 (0.49%) 
Myocardial infarction * 1  1/195 (0.51%)  1/204 (0.49%) 
Acute myocardial infarction * 1  0/195 (0.00%)  1/204 (0.49%) 
Angina pectoris * 1  0/195 (0.00%)  1/204 (0.49%) 
Atrioventricular block * 1  1/195 (0.51%)  0/204 (0.00%) 
Bradycardia * 1  1/195 (0.51%)  0/204 (0.00%) 
Cardiac arrest * 1  1/195 (0.51%)  0/204 (0.00%) 
Cardiac failure * 1  0/195 (0.00%)  1/204 (0.49%) 
Cardio-respiratory arrest * 1  1/195 (0.51%)  0/204 (0.00%) 
Cardiomyopathy * 1  0/195 (0.00%)  1/204 (0.49%) 
Cardiovascular disorder * 1  1/195 (0.51%)  0/204 (0.00%) 
Left ventricular dysfunction * 1  1/195 (0.51%)  0/204 (0.00%) 
Left ventricular failure * 1  0/195 (0.00%)  1/204 (0.49%) 
Myocardial ischaemia * 1  0/195 (0.00%)  1/204 (0.49%) 
Sinus tachycardia * 1  1/195 (0.51%)  0/204 (0.00%) 
Ventricular arrhythmia * 1  1/195 (0.51%)  0/204 (0.00%) 
Eye disorders     
Cataract * 1  4/195 (2.05%)  0/204 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  7/195 (3.59%)  0/204 (0.00%) 
Vomiting * 1  7/195 (3.59%)  0/204 (0.00%) 
Nausea * 1  4/195 (2.05%)  0/204 (0.00%) 
Constipation * 1  1/195 (0.51%)  2/204 (0.98%) 
Abdominal pain * 1  0/195 (0.00%)  2/204 (0.98%) 
Colitis * 1  1/195 (0.51%)  0/204 (0.00%) 
Colitis ischaemic * 1  1/195 (0.51%)  0/204 (0.00%) 
Dyspepsia * 1  0/195 (0.00%)  1/204 (0.49%) 
Lower gastrointestinal haemorrhage * 1  1/195 (0.51%)  0/204 (0.00%) 
General disorders     
Asthenia * 1  2/195 (1.03%)  2/204 (0.98%) 
Pyrexia * 1  3/195 (1.54%)  1/204 (0.49%) 
Fatigue * 1  2/195 (1.03%)  1/204 (0.49%) 
General physical health deterioration * 1  3/195 (1.54%)  0/204 (0.00%) 
Chest pain * 1  1/195 (0.51%)  1/204 (0.49%) 
Death * 1  1/195 (0.51%)  0/204 (0.00%) 
Multiple organ dysfunction syndrome * 1  1/195 (0.51%)  0/204 (0.00%) 
Non-cardiac chest pain * 1  1/195 (0.51%)  0/204 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute * 1  1/195 (0.51%)  0/204 (0.00%) 
Cholelithiasis * 1  1/195 (0.51%)  0/204 (0.00%) 
Hepatic cirrhosis * 1  0/195 (0.00%)  1/204 (0.49%) 
Liver disorder * 1  1/195 (0.51%)  0/204 (0.00%) 
Infections and infestations     
Pneumonia * 1  23/195 (11.79%)  24/204 (11.76%) 
Lower respiratory tract infection * 1  4/195 (2.05%)  3/204 (1.47%) 
Bronchitis * 1  3/195 (1.54%)  2/204 (0.98%) 
Gastroenteritis * 1  4/195 (2.05%)  1/204 (0.49%) 
Influenza * 1  3/195 (1.54%)  1/204 (0.49%) 
Septic shock * 1  4/195 (2.05%)  0/204 (0.00%) 
Upper respiratory tract infection * 1  3/195 (1.54%)  1/204 (0.49%) 
Urinary tract infection * 1  4/195 (2.05%)  0/204 (0.00%) 
Respiratory syncytial virus infection * 1  2/195 (1.03%)  1/204 (0.49%) 
Urosepsis * 1  3/195 (1.54%)  0/204 (0.00%) 
Cellulitis * 1  1/195 (0.51%)  1/204 (0.49%) 
Clostridium difficile colitis * 1  0/195 (0.00%)  2/204 (0.98%) 
Infection * 1  1/195 (0.51%)  1/204 (0.49%) 
Pneumonia pneumococcal * 1  2/195 (1.03%)  0/204 (0.00%) 
Staphylococcal sepsis * 1  1/195 (0.51%)  1/204 (0.49%) 
Chest wall abscess * 1  0/195 (0.00%)  1/204 (0.49%) 
Clostridium difficile infection * 1  1/195 (0.51%)  0/204 (0.00%) 
Corona virus infection * 1  1/195 (0.51%)  0/204 (0.00%) 
Escherichia bacteraemia * 1  1/195 (0.51%)  0/204 (0.00%) 
Gangrene * 1  0/195 (0.00%)  1/204 (0.49%) 
Gastroenteritis norovirus * 1  1/195 (0.51%)  0/204 (0.00%) 
H1N1 influenza * 1  0/195 (0.00%)  1/204 (0.49%) 
Laryngitis * 1  0/195 (0.00%)  1/204 (0.49%) 
Meningitis tuberculous * 1  1/195 (0.51%)  0/204 (0.00%) 
Orchitis * 1  1/195 (0.51%)  0/204 (0.00%) 
Pneumonia bacterial * 1  1/195 (0.51%)  0/204 (0.00%) 
Pneumonia fungal * 1  1/195 (0.51%)  0/204 (0.00%) 
Pneumonia influenzal * 1  1/195 (0.51%)  0/204 (0.00%) 
Pneumonia parainfluenzae viral * 1  1/195 (0.51%)  0/204 (0.00%) 
Pneumonia respiratory syncytial viral * 1  0/195 (0.00%)  1/204 (0.49%) 
Pulmonary sepsis * 1  0/195 (0.00%)  1/204 (0.49%) 
Sepsis * 1  1/195 (0.51%)  0/204 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture * 1  2/195 (1.03%)  1/204 (0.49%) 
Fall * 1  2/195 (1.03%)  0/204 (0.00%) 
Cervical vertebral fracture * 1  0/195 (0.00%)  1/204 (0.49%) 
Femoral neck fracture * 1  0/195 (0.00%)  1/204 (0.49%) 
Hip fracture * 1  1/195 (0.51%)  0/204 (0.00%) 
Injury * 1  1/195 (0.51%)  0/204 (0.00%) 
Overdose * 1  1/195 (0.51%)  0/204 (0.00%) 
Pelvic fracture * 1  1/195 (0.51%)  0/204 (0.00%) 
Postoperative respiratory failure * 1  1/195 (0.51%)  0/204 (0.00%) 
Rib fracture * 1  1/195 (0.51%)  0/204 (0.00%) 
Subdural haemorrhage * 1  0/195 (0.00%)  1/204 (0.49%) 
Investigations     
Blood glucose abnormal * 1  1/195 (0.51%)  0/204 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  3/195 (1.54%)  0/204 (0.00%) 
Hypokalaemia * 1  1/195 (0.51%)  1/204 (0.49%) 
Cachexia * 1  1/195 (0.51%)  0/204 (0.00%) 
Decreased appetite * 1  1/195 (0.51%)  0/204 (0.00%) 
Hyperkalaemia * 1  0/195 (0.00%)  1/204 (0.49%) 
Tumour lysis syndrome * 1  0/195 (0.00%)  1/204 (0.49%) 
Musculoskeletal and connective tissue disorders     
Bone pain * 1  1/195 (0.51%)  1/204 (0.49%) 
Back pain * 1  0/195 (0.00%)  1/204 (0.49%) 
Mobility decreased * 1  1/195 (0.51%)  0/204 (0.00%) 
Osteoarthritis * 1  1/195 (0.51%)  0/204 (0.00%) 
Osteochondrosis * 1  0/195 (0.00%)  1/204 (0.49%) 
Spinal pain * 1  1/195 (0.51%)  0/204 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Myelodysplastic syndrome * 1  0/195 (0.00%)  1/204 (0.49%) 
Ovarian neoplasm * 1  0/195 (0.00%)  1/204 (0.49%) 
Pancreatic carcinoma metastatic * 1  0/195 (0.00%)  1/204 (0.49%) 
Nervous system disorders     
Cerebral infarction * 1  0/195 (0.00%)  2/204 (0.98%) 
Neuropathy peripheral * 1  0/195 (0.00%)  2/204 (0.98%) 
Syncope * 1  1/195 (0.51%)  1/204 (0.49%) 
Transient ischaemic attack * 1  1/195 (0.51%)  1/204 (0.49%) 
Brain oedema * 1  1/195 (0.51%)  0/204 (0.00%) 
Carotid artery aneurysm * 1  1/195 (0.51%)  0/204 (0.00%) 
Cerebral haemorrhage * 1  1/195 (0.51%)  0/204 (0.00%) 
Cerebral ischaemia * 1  1/195 (0.51%)  0/204 (0.00%) 
Dementia Alzheimer's type * 1  1/195 (0.51%)  0/204 (0.00%) 
Encephalopathy * 1  1/195 (0.51%)  0/204 (0.00%) 
Hepatic encephalopathy * 1  0/195 (0.00%)  1/204 (0.49%) 
Ischaemic stroke * 1  0/195 (0.00%)  1/204 (0.49%) 
Metabolic encephalopathy * 1  1/195 (0.51%)  0/204 (0.00%) 
Neuralgia * 1  0/195 (0.00%)  1/204 (0.49%) 
Paraesthesia * 1  0/195 (0.00%)  1/204 (0.49%) 
Presyncope * 1  0/195 (0.00%)  1/204 (0.49%) 
Vascular dementia * 1  1/195 (0.51%)  0/204 (0.00%) 
Psychiatric disorders     
Affect lability * 1  1/195 (0.51%)  0/204 (0.00%) 
Mixed anxiety and depressive disorder * 1  1/195 (0.51%)  0/204 (0.00%) 
Personality change * 1  1/195 (0.51%)  0/204 (0.00%) 
Reactive psychosis * 1  1/195 (0.51%)  0/204 (0.00%) 
Renal and urinary disorders     
Acute kidney injury * 1  4/195 (2.05%)  2/204 (0.98%) 
Haematuria * 1  1/195 (0.51%)  0/204 (0.00%) 
Reproductive system and breast disorders     
Pelvic prolapse * 1  1/195 (0.51%)  0/204 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  1/195 (0.51%)  2/204 (0.98%) 
Dyspnoea * 1  2/195 (1.03%)  1/204 (0.49%) 
Epistaxis * 1  3/195 (1.54%)  0/204 (0.00%) 
Pulmonary embolism * 1  2/195 (1.03%)  1/204 (0.49%) 
Pulmonary oedema * 1  1/195 (0.51%)  1/204 (0.49%) 
Acute respiratory failure * 1  1/195 (0.51%)  0/204 (0.00%) 
Bronchiectasis * 1  1/195 (0.51%)  0/204 (0.00%) 
Bronchospasm * 1  1/195 (0.51%)  0/204 (0.00%) 
Pneumonitis * 1  1/195 (0.51%)  0/204 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  1/195 (0.51%)  2/204 (0.98%) 
Blood pressure fluctuation * 1  1/195 (0.51%)  0/204 (0.00%) 
Circulatory collapse * 1  0/195 (0.00%)  1/204 (0.49%) 
Embolism * 1  0/195 (0.00%)  1/204 (0.49%) 
Hypotension * 1  1/195 (0.51%)  0/204 (0.00%) 
Orthostatic hypotension * 1  0/195 (0.00%)  1/204 (0.49%) 
Peripheral ischaemia * 1  0/195 (0.00%)  1/204 (0.49%) 
Shock haemorrhagic * 1  1/195 (0.51%)  0/204 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SVd Arm: Selinexor + Bortezomib + Dexamethasone Vd Arm: Bortezomib + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   193/195 (98.97%)   197/204 (96.57%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  116/195 (59.49%)  55/204 (26.96%) 
Anaemia * 1  71/195 (36.41%)  45/204 (22.06%) 
Neutropenia * 1  29/195 (14.87%)  12/204 (5.88%) 
Leukopenia * 1  10/195 (5.13%)  3/204 (1.47%) 
Lymphopenia * 1  11/195 (5.64%)  4/204 (1.96%) 
Cardiac disorders     
Tachycardia * 1  10/195 (5.13%)  3/204 (1.47%) 
Eye disorders     
Cataract * 1  39/195 (20.00%)  13/204 (6.37%) 
Vision blurred * 1  13/195 (6.67%)  8/204 (3.92%) 
Visual impairment * 1  11/195 (5.64%)  4/204 (1.96%) 
Gastrointestinal disorders     
Nausea * 1  98/195 (50.26%)  20/204 (9.80%) 
Diarrhoea * 1  60/195 (30.77%)  51/204 (25.00%) 
Constipation * 1  33/195 (16.92%)  34/204 (16.67%) 
Vomiting * 1  39/195 (20.00%)  9/204 (4.41%) 
Abdominal pain * 1  15/195 (7.69%)  11/204 (5.39%) 
General disorders     
Fatigue * 1  82/195 (42.05%)  37/204 (18.14%) 
Asthenia * 1  47/195 (24.10%)  25/204 (12.25%) 
Oedema peripheral * 1  23/195 (11.79%)  26/204 (12.75%) 
Pyrexia * 1  28/195 (14.36%)  21/204 (10.29%) 
Infections and infestations     
Upper respiratory tract infection * 1  32/195 (16.41%)  29/204 (14.22%) 
Bronchitis * 1  21/195 (10.77%)  18/204 (8.82%) 
Nasopharyngitis * 1  23/195 (11.79%)  10/204 (4.90%) 
Pneumonia * 1  12/195 (6.15%)  9/204 (4.41%) 
Urinary tract infection * 1  12/195 (6.15%)  9/204 (4.41%) 
Lower respiratory tract infection * 1  12/195 (6.15%)  8/204 (3.92%) 
Investigations     
Weight decreased * 1  51/195 (26.15%)  25/204 (12.25%) 
Alanine aminotransferase increased * 1  13/195 (6.67%)  7/204 (3.43%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  69/195 (35.38%)  11/204 (5.39%) 
Hypokalaemia * 1  18/195 (9.23%)  9/204 (4.41%) 
Hyperglycaemia * 1  14/195 (7.18%)  11/204 (5.39%) 
Hypophosphataemia * 1  16/195 (8.21%)  6/204 (2.94%) 
Hypercreatininaemia * 1  13/195 (6.67%)  7/204 (3.43%) 
Hypocalcaemia * 1  15/195 (7.69%)  5/204 (2.45%) 
Hyponatraemia * 1  15/195 (7.69%)  3/204 (1.47%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  30/195 (15.38%)  28/204 (13.73%) 
Pain in extremity * 1  9/195 (4.62%)  17/204 (8.33%) 
Arthralgia * 1  8/195 (4.10%)  12/204 (5.88%) 
Muscle spasms * 1  3/195 (1.54%)  12/204 (5.88%) 
Nervous system disorders     
Neuropathy peripheral * 1  63/195 (32.31%)  96/204 (47.06%) 
Dizziness * 1  24/195 (12.31%)  8/204 (3.92%) 
Headache * 1  19/195 (9.74%)  11/204 (5.39%) 
Paraesthesia * 1  5/195 (2.56%)  15/204 (7.35%) 
Dysgeusia * 1  13/195 (6.67%)  1/204 (0.49%) 
Psychiatric disorders     
Insomnia * 1  31/195 (15.90%)  32/204 (15.69%) 
Confusional state * 1  16/195 (8.21%)  2/204 (0.98%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  35/195 (17.95%)  30/204 (14.71%) 
Dyspnoea * 1  18/195 (9.23%)  26/204 (12.75%) 
Dyspnoea exertional * 1  10/195 (5.13%)  8/204 (3.92%) 
Oropharyngeal pain * 1  12/195 (6.15%)  4/204 (1.96%) 
Epistaxis * 1  10/195 (5.13%)  3/204 (1.47%) 
Vascular disorders     
Hypertension * 1  17/195 (8.72%)  16/204 (7.84%) 
Hypotension * 1  10/195 (5.13%)  11/204 (5.39%) 
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jatin Shah, MD
Organization: Karyopharm Therapeutics Inc.
Phone: (617) 658-0600
EMail: jshah@karyopharm.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Grosicki S, Simonova M, Spicka I, Pour L, Kriachok I, Gavriatopoulou M, Pylypenko H, Auner HW, Leleu X, Doronin V, Usenko G, Bahlis NJ, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Gironella M, Jurczyszyn A, Robak P, Galli M, Wallington-Beddoe C, Radinoff A, Salogub G, Stevens DA, Basu S, Liberati AM, Quach H, Goranova-Marinova VS, Bila J, Katodritou E, Oliynyk H, Korenkova S, Kumar J, Jagannath S, Moreau P, Levy M, White D, Gatt ME, Facon T, Mateos MV, Cavo M, Reece D, Anderson LD Jr, Saint-Martin JR, Jeha J, Joshi AA, Chai Y, Li L, Peddagali V, Arazy M, Shah J, Shacham S, Kauffman MG, Dimopoulos MA, Richardson PG, Delimpasi S. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet. 2020 Nov 14;396(10262):1563-1573. doi: 10.1016/S0140-6736(20)32292-3.
Layout table for additonal information
Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT03110562    
Other Study ID Numbers: KCP-330-023
First Submitted: April 7, 2017
First Posted: April 12, 2017
Results First Submitted: June 15, 2021
Results First Posted: July 8, 2021
Last Update Posted: July 8, 2021