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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03110562
Registration number
NCT03110562
Ethics application status
Date submitted
7/04/2017
Date registered
12/04/2017
Date last updated
26/01/2023
Titles & IDs
Public title
Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
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Scientific title
A Phase 3 Randomized, Controlled, Open-label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
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Secondary ID [1]
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KCP-330-023
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Universal Trial Number (UTN)
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Trial acronym
BOSTON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Selinexor
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Active Comparator: selinexor+bortezomib+dexamethasone (SVd) - Selinexor will be given on Days 1, 8, 15, 22, and 29 of each 35-day cycle. Bortezomib will be given Days 1, 8, 15, and 22 of each 35-day cycle. Dexamethasone will be given Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle.
Active Comparator: bortezomib+dexamethasone (Vd) - Bortezomib will be given Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles. For cycles = 9, bortezomib will be given on Days 1, 8, 15, and 22 of each 35-day cycle. Dexamethasone will be given on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles. For cycles = 9, dexamethasone will be given on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle.
Treatment: Drugs: Selinexor
oral 100 mg dose
Treatment: Drugs: Bortezomib
subcutaneous dose of 1.3 mg/m2
Treatment: Drugs: Dexamethasone
oral dose of 20mg
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) as Assessed by IRC
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Assessment method [1]
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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%).
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Timepoint [1]
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From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 32 months)
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Secondary outcome [1]
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Overall Response Rate (ORR) as Assessed by IRC
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Assessment method [1]
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Timepoint [1]
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From date of randomization until disease progression or death, whichever occurred first (maximum duration up to 75 months)
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Secondary outcome [2]
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Percentage of Participants With Response Rates
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Assessment method [2]
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Timepoint [2]
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From date of randomization until disease progression or death, whichever occurred first (maximum duration up to 75 months)
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Timepoint [3]
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From date of randomization to the date of death or censored date, whichever occurred first (maximum duration of 75 months)
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Secondary outcome [4]
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Duration of Response (DOR) as Assessed by IRC
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Assessment method [4]
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Timepoint [4]
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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)
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Secondary outcome [5]
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Time-to-next-treatment (TTNT)
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Assessment method [5]
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Timepoint [5]
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From date of randomization to start of next anti-MM treatment or death, whichever occurs first (maximum duration of 75 months)
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Secondary outcome [6]
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Time-to-response (TTR) as Assessed by IRC
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Assessment method [6]
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Timepoint [6]
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From date of randomization until the date of first IRC confirmed response (maximum duration up to 75 months)
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Secondary outcome [7]
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Number of Participants With Grade >= 2 Peripheral Neuropathy Events
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Assessment method [7]
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Timepoint [7]
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From date of randomization up to 30 days after last dose of treatment (maximum duration of 75 months)
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Secondary outcome [8]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
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Assessment method [8]
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Timepoint [8]
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From date of randomization up to 30 days after last dose of treatment (maximum duration up to 75 months)
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Secondary outcome [9]
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Patient-reported Peripheral Neuropathy Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 Instrument
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Assessment method [9]
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Timepoint [9]
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Up to 75 months
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Eligibility
Key inclusion criteria
1. Histologically confirmed MM with measurable disease per IMWG guidelines as defined by
at least 1 of the following:
- Serum M-protein = 0.5 g/dL (> 5 g/L) by serum protein electrophoresis (SPEP) or
for immunoglobulin (Ig) A myeloma, by quantitative serum IgA levels; or
- Urinary M-protein excretion at least 200 mg/24 hours; or
- Serum free light chain (FLC) = 100 mg/L, provided that the serum FLC ratio is
abnormal.
2. Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens.
Induction therapy followed by stem cell transplant and consolidation/maintenance
therapy will be considered as 1 anti-MM regimen.
3. Documented evidence of progressive MM (based on the Investigator's determination
according to the modified IMWG response criteria) on or after their most recent
regimen.
4. Prior treatment with bortezomib or other Proteasome Inhibitor (PI) is allowed,
provided all of the following criteria are met:
- Best response achieved with prior bortezomib at any time was = PR and with the
last PI (PI therapy (alone or in combination) was = PR, AND
- Participant did not discontinue bortezomib due to = Grade 3 related toxicity, AND
- Must have had at least a 6-month PI-treatment-free interval prior to Cycle 1 Day
1 (C1D1) of study treatment.
5. Must have an ECOG Status score of 0, 1, or 2.
6. Written informed consent in accordance with federal, local, and institutional
guidelines.
7. Age =18 years.
8. Resolution of any clinically significant non-hematological toxicities (if any) from
previous treatments to = Grade 1 by C1D1.
9. Adequate hepatic function within 28 days prior to C1D1.
10. Adequate renal function within 28 days prior to C1D1.
11. Adequate hematopoietic function within 7 days prior to C1D1.
12. Female patients of childbearing potential must have a negative serum pregnancy test at
Screening. Female patients of childbearing potential and fertile male patients who are
sexually active with a female of childbearing potential must use highly effective
methods of contraception throughout the study and for 3 months following the last dose
of study treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior exposure to a SINE compound (i.e. an XPO-1 inhibitor), including selinexor.
2. Prior malignancy that required treatment, or has shown evidence of recurrence (except
for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during
the 5 years prior to randomization.
3. Any concurrent medical condition or disease (e.g., uncontrolled active hypertension,
uncontrolled active diabetes, active systemic infection, etc.) that is likely to
interfere with study procedures.
4. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or
antifungals within 1 week prior to C1D1.
5. Active plasma cell leukemia.
6. Documented systemic light chain amyloidosis.
7. MM involving the central nervous system.
8. Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes
(POEMS) syndrome.
9. Spinal cord compression.
10. Greater than Grade 2 neuropathy or = Grade 2 neuropathy with pain at baseline,
regardless of whether or not the patient is currently receiving medication
11. Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
12. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy (including
investigational therapies) = 2 weeks prior to C1D1. Localized radiation to a single
site at least 1 week before C1D1 is permitted. Glucocorticoids within 2 weeks of C1D1
are permitted. Patients on long-term glucocorticoids during Screening do not require a
washout period but must be able to tolerate the specified dexamethasone dose in this
study.
13. Prior autologous stem cell transplantation < 1 month or allogeneic stem cell
transplantation < 4 months prior to C1D1.
14. Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.
15. Pregnant or breastfeeding females.
16. Body Surface Area < 1.4 m² at baseline, calculated by the Dubois or Mosteller method.
17. Life expectancy of < 4 months.
18. Major surgery within 4 weeks prior to C1D1.
19. Active, unstable cardiovascular function:
1. Symptomatic ischemia, or
2. Uncontrolled clinically significant conduction abnormalities (e.g., patients with
ventricular tachycardia on anti-arrhythmics are excluded; patients with
first-degree atrioventricular block or asymptomatic left anterior fascicular
block/right bundle branch block will not be excluded), or
3. Congestive heart failure of New York Heart Association Class = 3 or known left
ventricular ejection fraction < 40%, or
4. Myocardial infarction within 3 months prior to C1D1.
20. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity
21. Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C
virus ribonucleic acid (RNA) or hepatitis B virus surface antigen.
22. Any active gastrointestinal dysfunction interfering with the patient's ability to
swallow tablets, or any active gastrointestinal dysfunction that could interfere with
absorption of study treatment.
23. Any active, serious psychiatric, medical, or other conditions/situations that, in the
opinion of the Investigator, could interfere with treatment, compliance, or the
ability to give informed consent.
24. Contraindication to any of the required concomitant drugs or supportive treatments.
25. Patients unwilling or unable to comply with the protocol, including providing 24-hour
urine samples for urine protein electrophoresis at the required time points.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
402
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Herston
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Mater Misericordiae Limited and Mater Medical Research - South Brisbane
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Gold Coast University Hospital - Southport
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre - Bedford Park
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St. Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [8]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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4029 - Herston
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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5000 - Adelaide
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Recruitment postcode(s) [6]
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5042 - Bedford Park
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Recruitment postcode(s) [7]
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3065 - Fitzroy
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment outside Australia
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Russian Federation
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State/province [87]
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Moscow
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Country [88]
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Russian Federation
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State/province [88]
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Saint Petersburg
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Country [89]
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Novi Sad
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Spain
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State/province [93]
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Santa Cruz De Tenerife
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Country [94]
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Spain
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Badalona
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Spain
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Barcelona
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Country [96]
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Spain
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Madrid
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Country [97]
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Spain
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Salamanca
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Country [98]
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Spain
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Seville
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Country [99]
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Ukraine
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State/province [99]
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Cherkasy
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Country [100]
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Ukraine
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State/province [100]
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Dnipropetrovsk
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Country [101]
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Ukraine
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State/province [101]
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Kiev
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Country [102]
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Ukraine
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State/province [102]
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Lviv
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Country [103]
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Ukraine
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State/province [103]
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Vinnytsia
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Ukraine
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Zhytomyr
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Country [105]
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United Kingdom
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State/province [105]
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Northern Ireland
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Country [106]
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United Kingdom
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State/province [106]
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Scotland
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Country [107]
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United Kingdom
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Wales
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Country [108]
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United Kingdom
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State/province [108]
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Birmingham
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Country [109]
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United Kingdom
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State/province [109]
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Leeds
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Country [110]
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United Kingdom
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State/province [110]
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Leicester
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Country [111]
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United Kingdom
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State/province [111]
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Liverpool
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Country [112]
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United Kingdom
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State/province [112]
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London
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Country [113]
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United Kingdom
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State/province [113]
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Manchester
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Country [114]
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United Kingdom
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State/province [114]
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Newcastle Upon Tyne
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Country [115]
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United Kingdom
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State/province [115]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Karyopharm Therapeutics Inc
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Summary
Brief summary
This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study
will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety
of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib
plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior
anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes
selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease
progression per the IMWG criteria for patients in the Vd Arm.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03110562
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03110562
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