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

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Selinexor
Bortezomib
Dexamethasone
Sponsored by
Karyopharm Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed or Refractory Multiple Myeloma, RRMM, Bortezomib, Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Boca Raton Clinical Research (BRCR) Medical Center
  • Emory University
  • Kaiser Permanente Hawaii
  • McFarland Clinic
  • Stormont Vail Health Care (Cotton O'Neil Cancer Center )
  • Commonwealth Hematology
  • Norton Cancer Institute
  • University of Maryland
  • Central Care Cancer Center
  • The Valley Hospital Luckow Pavilion
  • Mount Sinai
  • The Cancer Institute at St. Francis Hospital
  • Novant-Forsyth Memorial Hospital
  • University of Cincinnati Health
  • Southwest Cancer Center of Oklahoma
  • Kaiser Permanente Northwest OR
  • SCOR AnMed Health Cancer Center
  • Prairie Lakes Healthcare
  • Baylor Sammons Cancer Center
  • University of Texas Southwestern
  • Calvary Mater Newcastle
  • Royal Brisbane and Women's Hospital
  • Mater Misericordiae Limited and Mater Medical Research
  • Gold Coast University Hospital
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • St. Vincent's Hospital Melbourne
  • The Alfred Hospital
  • Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
  • University Hospital Krems, Department of Internal Medicine II
  • Medical University of Vienna
  • General Hospital Hietzing
  • Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology
  • Jules Bordet Institute
  • UCL Saint-Luc
  • University Hospital Ghent
  • General Hospital Delta
  • St. Augustinus Hospital
  • University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology
  • University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology
  • Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology
  • Tom Baker Cancer Center/ Alberta Health Services
  • Cross Cancer Institute / University of Alberta
  • Vancouver General Hospital
  • Queen Elizabeth II Health Sciences Center
  • North East Cancer Centre Sudbury
  • Princess Margaret Cancer Research
  • Maisonneuve-Rosemont Hospital
  • Royal Victoria Hospital / McGill University
  • L'Hôtel-Dieu de Québec
  • Saskatchewan Cancer Agency-Allan Blair Cancer Centre
  • Saskatoon Cancer Center
  • General University Hospital in Prague
  • University Hopsital Brno
  • University Hospital Hradec Kralove
  • University Hospital Olomouc
  • University Hospital Ostrava, Dept. of Hematooncology
  • University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
  • Necker Children's Hospital, Department of Adult Hematology
  • Hospital Center Departmental La Roche-Sur-Yon
  • Claude Huriez Hospital
  • South Lyon Hospital Center
  • Brabois Adults Hospital, University Hospital Center of Nancy
  • Nantes University Hospital Center
  • Saint-Louis Hospital
  • Miletrie Hospital, University Hospital Center of Poitiers
  • University Hospital Freiburg, Department of Internal Medicine I
  • Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3
  • Group Practice for Hematology and Oncology
  • Alexandra General Hospital, Therapeutic Clinic
  • General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma
  • University General Hospital of Patra
  • Theageneion Cancer Hospital, Hematology Department
  • Semmelweis University, 1st Department of Internal Medicine
  • Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation
  • Semmelweis University, 3rd Department of Internal Medicine
  • Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine
  • Medical Center of the University of Pecs, Department of Hematology
  • Regional Cancer Centre
  • Regional Cancer Centre
  • Prince Aly Khan Hospital
  • Jaslok Hospital and Research Centre
  • Bhaktivedanta Hospital
  • IMS & SUM Hospital
  • Postgraduate Institute of Medical Education & Research (PGIMER)
  • Dayanand Medical College & Hospital
  • Cancer Institute
  • SRM Institute of Medical Sciences
  • Saveetha Medical College Hospital
  • G. Kuppuswamy Naidu Hospital
  • Asviratham Speciality Hospital
  • Meenakshi Mission Hospital
  • Yashoda Hospital
  • King George's Medical University
  • Netaji Subhash Chandra Bose Cancer Research Institute
  • Nil Ratan Sircar (NRS) Medical College
  • TATA Memorial Centre
  • Rajiv Gandhi Cancer Hospital
  • Barzilai Medical Center
  • Rambam Health Care Campus
  • Hadassah Medical Center
  • Rabin Medical Center
  • Hospital Santa Maria of Terni
  • Azienda Ospedaliero-Universitaria Ospedali Riuniti
  • ASST Papa Giovanni XXIII
  • Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo
  • University Hospital Careggi, Department of Hematology
  • University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology
  • Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit
  • Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center
  • University Hospital San Giovanni Battista of Turin
  • Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology
  • Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology
  • University Hospital in Krakow, Teaching Unit of the Hematology Department
  • Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation
  • St. John of Dukla Oncology Center of Lublin, Department of Hematology
  • Military Institute of Medicine, Department of Internal Medicine and Hematology
  • Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology
  • Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department
  • Colentina Clinical Hospital, Department of Hematology
  • Bucharest University Emergency Hospital, Department of Hematology
  • S.P. Botkin City Clinical Hospital
  • N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways
  • First I.P. Pavlov State Medical University of St. Petersburg
  • V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1
  • Clinical Center of Serbia, Clinic of Hematology
  • Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology
  • Clinical Center Kragujevac, Clinic of Hematology
  • Clinical Center Nis, Clinic of Hematology and Clinical Immunology
  • Clinical Center of Vojvodina, Clinic of Hematology
  • University Hospital of the Canary Islands
  • Catalan Institute of Oncology (ICO) Badalona
  • University Hospital of Vall d'Hebron
  • University Hospital Infanta Leonor, Department of Hematology
  • University Clinical Hospital of Salamanca, Department of Hematology
  • University Hospital Virgen del Rocio (HUVR)
  • Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
  • City Clinical Hospital No.4 of Dnipro City Council, City hematology center
  • BMT Kiev Center
  • Kiev Cancer Institute
  • Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group
  • Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology
  • O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards
  • Belfast Heatlh & Social Care Trust Belfast City Hospital
  • NHS Tayside Ninewells Hospital
  • Cardiff & Vale University Health Board University Hospital of Wales
  • University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
  • The Leeds Teaching Hospitals NHS Trust St. James University Hospital
  • University Hospitals of Leicester NHS Trust Royal Leicester Infirmary
  • Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital
  • London North West Healthcare NHS Trust Northwick Park Hospital
  • University College London
  • King's College Hospital NHS Foundation Trust
  • Imperial College Healthcare NHS Trust Hammersmith Hospital
  • The Christie NHS Foundation Trust
  • Freeman Hospital
  • The Royal Wolverhampton NHS Trust New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

selinexor+bortezomib+dexamethasone (SVd)

bortezomib+dexamethasone (Vd)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) as Assessed by IRC
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%).

Secondary Outcome Measures

Overall Response Rate (ORR) as Assessed by IRC
Percentage of Participants With Response Rates
Overall Survival (OS)
Duration of Response (DOR) as Assessed by IRC
Time-to-next-treatment (TTNT)
Time-to-response (TTR) as Assessed by IRC
Number of Participants With Grade >= 2 Peripheral Neuropathy Events
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Patient-reported Peripheral Neuropathy Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 Instrument

Full Information

First Posted
April 7, 2017
Last Updated
January 24, 2023
Sponsor
Karyopharm Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03110562
Brief Title
Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
Acronym
BOSTON
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karyopharm Therapeutics Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed or Refractory Multiple Myeloma, RRMM, Bortezomib, Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
selinexor+bortezomib+dexamethasone (SVd)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
bortezomib+dexamethasone (Vd)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Selinexor
Intervention Description
oral 100 mg dose
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade®
Intervention Description
subcutaneous dose of 1.3 mg/m2
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
oral dose of 20mg
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed by IRC
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)
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) as Assessed by IRC
Time Frame
From date of randomization until disease progression or death, whichever occurred first (maximum duration up to 75 months)
Title
Percentage of Participants With Response Rates
Time Frame
From date of randomization until disease progression or death, whichever occurred first (maximum duration up to 75 months)
Title
Overall Survival (OS)
Time Frame
From date of randomization to the date of death or censored date, whichever occurred first (maximum duration of 75 months)
Title
Duration of Response (DOR) as Assessed by IRC
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)
Title
Time-to-next-treatment (TTNT)
Time Frame
From date of randomization to start of next anti-MM treatment or death, whichever occurs first (maximum duration of 75 months)
Title
Time-to-response (TTR) as Assessed by IRC
Time Frame
From date of randomization until the date of first IRC confirmed response (maximum duration up to 75 months)
Title
Number of Participants With Grade >= 2 Peripheral Neuropathy Events
Time Frame
From date of randomization up to 30 days after last dose of treatment (maximum duration of 75 months)
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time Frame
From date of randomization up to 30 days after last dose of treatment (maximum duration up to 75 months)
Title
Patient-reported Peripheral Neuropathy Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 Instrument
Time Frame
Up to 75 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. 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. 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. Must have an ECOG Status score of 0, 1, or 2. Written informed consent in accordance with federal, local, and institutional guidelines. Age ≥18 years. Resolution of any clinically significant non-hematological toxicities (if any) from previous treatments to ≤ Grade 1 by C1D1. Adequate hepatic function within 28 days prior to C1D1. Adequate renal function within 28 days prior to C1D1. Adequate hematopoietic function within 7 days prior to C1D1. 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. Exclusion Criteria: Prior exposure to a SINE compound (i.e. an XPO-1 inhibitor), including selinexor. 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. 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. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1. Active plasma cell leukemia. Documented systemic light chain amyloidosis. MM involving the central nervous system. Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. Spinal cord compression. Greater than Grade 2 neuropathy or ≥ Grade 2 neuropathy with pain at baseline, regardless of whether or not the patient is currently receiving medication Known intolerance, hypersensitivity, or contraindication to glucocorticoids. 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. Prior autologous stem cell transplantation < 1 month or allogeneic stem cell transplantation < 4 months prior to C1D1. Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1. Pregnant or breastfeeding females. Body Surface Area < 1.4 m² at baseline, calculated by the Dubois or Mosteller method. Life expectancy of < 4 months. Major surgery within 4 weeks prior to C1D1. Active, unstable cardiovascular function: Symptomatic ischemia, or 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 Congestive heart failure of New York Heart Association Class ≥ 3 or known left ventricular ejection fraction < 40%, or Myocardial infarction within 3 months prior to C1D1. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity 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. 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. 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. Contraindication to any of the required concomitant drugs or supportive treatments. Patients unwilling or unable to comply with the protocol, including providing 24-hour urine samples for urine protein electrophoresis at the required time points.
Facility Information:
Facility Name
Boca Raton Clinical Research (BRCR) Medical Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Kaiser Permanente Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Stormont Vail Health Care (Cotton O'Neil Cancer Center )
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Commonwealth Hematology
City
Danville
State/Province
Kentucky
ZIP/Postal Code
40422
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Central Care Cancer Center
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
The Valley Hospital Luckow Pavilion
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Cancer Institute at St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Novant-Forsyth Memorial Hospital
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Southwest Cancer Center of Oklahoma
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73505
Country
United States
Facility Name
Kaiser Permanente Northwest OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
SCOR AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Prairie Lakes Healthcare
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Misericordiae Limited and Mater Medical Research
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
City
Innsbruck
Country
Austria
Facility Name
University Hospital Krems, Department of Internal Medicine II
City
Krems
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
General Hospital Hietzing
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Facility Name
Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Jules Bordet Institute
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UCL Saint-Luc
City
Brussels
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
General Hospital Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
St. Augustinus Hospital
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Tom Baker Cancer Center/ Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Cross Cancer Institute / University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
North East Cancer Centre Sudbury
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Princess Margaret Cancer Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Royal Victoria Hospital / McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
L'Hôtel-Dieu de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Saskatchewan Cancer Agency-Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7TI
Country
Canada
Facility Name
Saskatoon Cancer Center
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
General University Hospital in Prague
City
Praha 2
State/Province
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
University Hopsital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
University Hospital Ostrava, Dept. of Hematooncology
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Necker Children's Hospital, Department of Adult Hematology
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75015
Country
France
Facility Name
Hospital Center Departmental La Roche-Sur-Yon
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Claude Huriez Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
South Lyon Hospital Center
City
Lyon
ZIP/Postal Code
69002
Country
France
Facility Name
Brabois Adults Hospital, University Hospital Center of Nancy
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Nantes University Hospital Center
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Saint-Louis Hospital
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Miletrie Hospital, University Hospital Center of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
University Hospital Freiburg, Department of Internal Medicine I
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3
City
Leverkusen
State/Province
North Rhine Westfalia
ZIP/Postal Code
51375
Country
Germany
Facility Name
Group Practice for Hematology and Oncology
City
Dresden
State/Province
Saxony
ZIP/Postal Code
1307
Country
Germany
Facility Name
Alexandra General Hospital, Therapeutic Clinic
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma
City
Athens
Country
Greece
Facility Name
University General Hospital of Patra
City
Pátra
Country
Greece
Facility Name
Theageneion Cancer Hospital, Hematology Department
City
Thessaloníki
ZIP/Postal Code
54639
Country
Greece
Facility Name
Semmelweis University, 1st Department of Internal Medicine
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
Facility Name
Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
Facility Name
Semmelweis University, 3rd Department of Internal Medicine
City
Budapest
ZIP/Postal Code
H-1125
Country
Hungary
Facility Name
Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Medical Center of the University of Pecs, Department of Hematology
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Regional Cancer Centre
City
Patna
State/Province
Bihar
ZIP/Postal Code
800014
Country
India
Facility Name
Regional Cancer Centre
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Prince Aly Khan Hospital
City
Mumbai
State/Province
Maharashta
ZIP/Postal Code
400010
Country
India
Facility Name
Jaslok Hospital and Research Centre
City
Mumbai
State/Province
Maharashta
ZIP/Postal Code
400026
Country
India
Facility Name
Bhaktivedanta Hospital
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
401107
Country
India
Facility Name
IMS & SUM Hospital
City
Bhubaneswar
State/Province
Odisha
ZIP/Postal Code
751003
Country
India
Facility Name
Postgraduate Institute of Medical Education & Research (PGIMER)
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
Dayanand Medical College & Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
Cancer Institute
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600020
Country
India
Facility Name
SRM Institute of Medical Sciences
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600026
Country
India
Facility Name
Saveetha Medical College Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
602105
Country
India
Facility Name
G. Kuppuswamy Naidu Hospital
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641037
Country
India
Facility Name
Asviratham Speciality Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625020
Country
India
Facility Name
Meenakshi Mission Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625107
Country
India
Facility Name
Yashoda Hospital
City
Hyderabad
State/Province
Telengana
ZIP/Postal Code
500082
Country
India
Facility Name
King George's Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Netaji Subhash Chandra Bose Cancer Research Institute
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700094
Country
India
Facility Name
Nil Ratan Sircar (NRS) Medical College
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700120
Country
India
Facility Name
TATA Memorial Centre
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700160
Country
India
Facility Name
Rajiv Gandhi Cancer Hospital
City
New Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petaẖ Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Hospital Santa Maria of Terni
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Ospedali Riuniti
City
Ancona
ZIP/Postal Code
60131
Country
Italy
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
University Hospital Careggi, Department of Hematology
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
University Hospital San Giovanni Battista of Turin
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
University Hospital in Krakow, Teaching Unit of the Hematology Department
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
St. John of Dukla Oncology Center of Lublin, Department of Hematology
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Military Institute of Medicine, Department of Internal Medicine and Hematology
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department
City
Braşov
ZIP/Postal Code
500366
Country
Romania
Facility Name
Colentina Clinical Hospital, Department of Hematology
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Bucharest University Emergency Hospital, Department of Hematology
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
S.P. Botkin City Clinical Hospital
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
First I.P. Pavlov State Medical University of St. Petersburg
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Clinical Center of Serbia, Clinic of Hematology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac, Clinic of Hematology
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
Facility Name
Clinical Center Nis, Clinic of Hematology and Clinical Immunology
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Clinical Center of Vojvodina, Clinic of Hematology
City
Novi Sad
ZIP/Postal Code
21 000
Country
Serbia
Facility Name
University Hospital of the Canary Islands
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Catalan Institute of Oncology (ICO) Badalona
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
University Hospital of Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
University Hospital Infanta Leonor, Department of Hematology
City
Madrid
ZIP/Postal Code
28301
Country
Spain
Facility Name
University Clinical Hospital of Salamanca, Department of Hematology
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
University Hospital Virgen del Rocio (HUVR)
City
Seville
ZIP/Postal Code
41013
Country
Spain
Facility Name
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
City Clinical Hospital No.4 of Dnipro City Council, City hematology center
City
Dnipropetrovsk
Country
Ukraine
Facility Name
BMT Kiev Center
City
Kiev
Country
Ukraine
Facility Name
Kiev Cancer Institute
City
Kiev
Country
Ukraine
Facility Name
Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards
City
Zhytomyr
ZIP/Postal Code
10008
Country
Ukraine
Facility Name
Belfast Heatlh & Social Care Trust Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
NHS Tayside Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Cardiff & Vale University Health Board University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust St. James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust Royal Leicester Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
London North West Healthcare NHS Trust Northwick Park Hospital
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
University College London
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34882831
Citation
Delimpasi S, Mateos MV, Auner HW, Gavriatopoulou M, Dimopoulos MA, Quach H, Pylypenko H, Hajek R, Leleu X, Dolai TK, Sinha DK, Venner CP, Benjamin R, Garg MK, Doronin V, Levy Y, Moreau P, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in comparison with standard twice-weekly bortezomib and dexamethasone in previously treated multiple myeloma with renal impairment: Subgroup analysis from the BOSTON study. Am J Hematol. 2022 Mar 1;97(3):E83-E86. doi: 10.1002/ajh.26434. Epub 2021 Dec 29. No abstract available.
Results Reference
derived
PubMed Identifier
34062004
Citation
Richard S, Chari A, Delimpasi S, Simonova M, Spicka I, Pour L, Kriachok I, Dimopoulos MA, Pylypenko H, Auner HW, Leleu X, Usenko G, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros A, Anderson LD Jr, Bahlis NJ, Facon T, Mateos MV, Cavo M, Chang H, Landesman Y, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Grosicki S, Richardson PG. Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk. Am J Hematol. 2021 Sep 1;96(9):1120-1130. doi: 10.1002/ajh.26261. Epub 2021 Jul 5.
Results Reference
derived
PubMed Identifier
33849608
Citation
Mateos MV, Gavriatopoulou M, Facon T, Auner HW, Leleu X, Hajek R, Dimopoulos MA, Delimpasi S, Simonova M, Spicka I, Pour L, Kriachok I, Pylypenko H, Doronin V, Usenko G, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros AZ, Anderson LD Jr, Bahlis NJ, Cavo M, Chai Y, Jeha J, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Effect of prior treatments on selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma. J Hematol Oncol. 2021 Apr 13;14(1):59. doi: 10.1186/s13045-021-01071-9.
Results Reference
derived
PubMed Identifier
33755235
Citation
Auner HW, Gavriatopoulou M, Delimpasi S, Simonova M, Spicka I, Pour L, Dimopoulos MA, Kriachok I, Pylypenko H, Leleu X, Doronin V, Usenko G, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros A, Anderson LD Jr, Bahlis NJ, Facon T, Mateos MV, Cavo M, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Effect of age and frailty on the efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma. Am J Hematol. 2021 Jun 1;96(6):708-718. doi: 10.1002/ajh.26172. Epub 2021 May 3.
Results Reference
derived
PubMed Identifier
33189178
Citation
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.
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Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma

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