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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03110562




Registration number
NCT03110562
Ethics application status
Date submitted
7/04/2017
Date registered
12/04/2017

Titles & IDs
Public title
Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
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)
Secondary ID [1] 0 0
KCP-330-023
Universal Trial Number (UTN)
Trial acronym
BOSTON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Selinexor
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone

Experimental: SVd Arm: Selinexor + Bortezomib + Dexamethasone - 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.

Experimental: Vd Arm: Bortezomib + Dexamethasone - Participants received SC injection of 1.3 mg/m\^2 bortezomib 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.

Experimental: SVdX Arm: Selinexor + Bortezomib + Dexamethasone - Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive 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.

Experimental: SdX Arm: Selinexor + Dexamethasone - Participants in the VD arm who had IRC-confirmed PD and were unable to tolerate continued bortezomib treatment had crossed over to receive 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 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.


Treatment: Drugs: Selinexor
oral 100 mg dose

Treatment: Drugs: Bortezomib
subcutaneous dose of 1.3 mg/m2

Treatment: Drugs: Dexamethasone
oral dose of 20mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SVd/Vd Arm: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
Timepoint [1] 0 0
From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months)
Secondary outcome [1] 0 0
SVd/Vd Arm: Overall Response Rate (ORR) as Assessed by IRC
Timepoint [1] 0 0
From date of randomization until disease progression or initiating a new MM treatment (up to 33 months)
Secondary outcome [2] 0 0
SVd/Vd Arm: Percentage of Participants With Response Rate of Very Good Partial Response (VGPR) or Better Based on IRC Assessment
Timepoint [2] 0 0
From date of randomization until confirmed PD or initiating a new MM treatment (up to 33 months)
Secondary outcome [3] 0 0
SVd/Vd Arm: Number of Participants With at Least One Grade Greater Than or Equal to [>=] 2 Peripheral Neuropathy Events
Timepoint [3] 0 0
From first dose of study treatment to 30 days after the last dose of study treatment inclusive, or the day before the start of new anti-MM treatment, whichever occurs first (up to 33 months)
Secondary outcome [4] 0 0
SVd/Vd Arm: Overall Survival (OS)
Timepoint [4] 0 0
From date of randomization to the date of death or censored date, whichever occurred first (up to 45 months)
Secondary outcome [5] 0 0
SVd/Vd Arm: Duration of Response (DOR) as Assessed by IRC
Timepoint [5] 0 0
From the first documentation of response to the first documentation of PD or death, whichever occurred first (up to 45 months)
Secondary outcome [6] 0 0
SVdX Arm: Overall Response Rate (ORR1) as Assessed by IRC During SVdX Treatment
Timepoint [6] 0 0
From date of first SVdX treatment until disease progression or initiating a new MM treatment (up to 33 months)
Secondary outcome [7] 0 0
SVdX Arm: Progression Free Survival1 (PFS1) as Assessed by IRC During SVdX Treatment
Timepoint [7] 0 0
From date of first SVdX treatment until IRC-confirmed documented PD or death or censored date, whichever occurred first (up to 33 months)
Secondary outcome [8] 0 0
SVd/Vd Arm: Time-to-next-treatment (TTNT) in Participants Randomized to the SVd and Vd Arm Who Received Treatment After SVd/Vd
Timepoint [8] 0 0
From date of randomization to start of next anti-MM treatment or death, whichever occurred first (up to 33 months)
Secondary outcome [9] 0 0
SVd/Vd Arm: Time To Response (TTR) in Participants Randomized to the SVd and Vd Arm
Timepoint [9] 0 0
From randomization to the date of first IRC-confirmed PR or better (i.e., PR, VGPR, CR, or sCR), whichever occurred first (up to 33 months)
Secondary outcome [10] 0 0
SVd/Vd/SVdx Arm: Progression Free Survival 2 (PFS 2) in Participants Randomized to the SVd and Vd Arm Who Received Post-SVd/Vd/SVdX Treatment
Timepoint [10] 0 0
From date of first dose of post-SVd/Vd/SVdX treatment to the date of first PD on post-SVd/Vd/SVdX treatment, or death due to any cause (up to 33 months)
Secondary outcome [11] 0 0
SVd/Vd Arm: Change From Baseline in Participant-Reported Peripheral Neuropathy (PN) Assessed by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire- Chemotherapy-Induced PN 20 (EORTC- QLQ-CIPN20) Total Scores
Timepoint [11] 0 0
Svd Arm: Baseline up to End of treatment (EOT) (at Day 820); Vd Arm: Baseline up to EOT (at Day 848)

Eligibility
Key inclusion criteria
1. Histologically confirmed MM with measurable disease per IMWG guidelines as defined by at least 1 of the following:

1. 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
2. Urinary M-protein excretion at least 200 mg/24 hours; or
3. Serum free light chain (FLC) = 100 mg/L, provided that the serum FLC ratio is abnormal (normal FLC ratio: 0.26 to 1.65).
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:

1. 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
2. Participant did not discontinue bortezomib due to = Grade 3 related toxicity, AND
3. 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. Patients with chronic, stable Grade 2 non-hematological toxicities may be included following approval from the Medical Monitor.
9. Adequate hepatic function within 28 days prior to C1D1.

1. Total bilirubin <1.5 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of <3 × ULN), and
2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal to <2 × ULN.
10. Adequate renal function within 28 days prior to C1D1 (estimated creatinine clearance [CrCl] of =20 mL/min, calculated using the formula of Cockroft and Gault):

(140-Age) × Mass (kg)/(72 × creatinine mg/dL) Multiply by 0.85 if the patient is female, or if CrCl is =20 mL/min as measured by 24-hour urine collection.

11. Adequate hematopoietic function within 7 days prior to C1D1: total white blood cell (WBC) count =1500/mm3, absolute neutrophil count =1000/mm3, hemoglobin =8.5 g/dL and platelet count =75,000/mm3 (patients for whom < 50% of bone marrow nucleated cells are plasma cells) or =50,000/mm3 (patients for whom =50% of bone marrow nucleated cells are plasma cells).

1. Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, romiplostim, or interleukin-11) must have a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study.
2. Patients must have:

* At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the Screening hemoglobin assessment, and
* At least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment.

However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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. Cancer treated with curative intent for >5 years previously and without evidence of recurrence will be allowed.
3. Has 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. Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/05/2022
Sample size
Target
Accrual to date
Final
402
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Mater Misericordiae Limited and Mater Medical Research - South Brisbane
Recruitment hospital [4] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
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United States of America
State/province [3] 0 0
Hawaii
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United States of America
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Iowa
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United States of America
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Kansas
Country [6] 0 0
United States of America
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Kentucky
Country [7] 0 0
United States of America
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Maryland
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Missouri
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New Jersey
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United States of America
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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South Carolina
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South Dakota
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United States of America
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Texas
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Austria
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Innsbruck
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Austria
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Krems
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Ghent
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Roeselare
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Wilrijk
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Plovdiv
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Sofia
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Alberta
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British Columbia
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Nova Scotia
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Ontario
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Saskatchewan
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Prague
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Czechia
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Hradec Kralove
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Olomouc
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Ostrava
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Lille
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Poitiers
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Baden-Wuerttemberg
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Germany
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North Rhine Westfalia
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Germany
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Saxony
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Athens
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Pátra
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Kerala
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Maharashta
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India
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Odisha
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Punjab
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India
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Tamil Nadu
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India
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Telengana
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Uttar Pradesh
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India
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West Bengal
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India
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New Delhi
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Israel
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Ashkelon
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Israel
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Haifa
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Jerusalem
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Israel
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Peta? Tiqwa
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Italy
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Umbria
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Italy
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Ancona
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Italy
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Bergamo
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Italy
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Bologna
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Florence
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Genoa
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Milan
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Rome
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Turin
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Bydgoszcz
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Chorzow
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Krakow
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Lublin
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Warsaw
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Lódz
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Romania
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Brasov
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Romania
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Bucharest
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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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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Santa Cruz De Tenerife
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Seville
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Ukraine
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Cherkasy
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kiev
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Ukraine
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Lviv
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Ukraine
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Vinnytsia
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Ukraine
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Zhytomyr
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United Kingdom
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Northern Ireland
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United Kingdom
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Scotland
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United Kingdom
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Wales
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United Kingdom
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Birmingham
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
State/province [114] 0 0
Newcastle Upon Tyne
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United Kingdom
State/province [115] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Karyopharm Therapeutics Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03110562