Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
BOSTON
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)
1 other identifier
interventional
402
20 countries
152
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-myeloma
Started May 2017
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
May 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2020
CompletedResults Posted
Study results publicly available
July 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2022
CompletedAugust 21, 2024
July 1, 2024
2.7 years
April 7, 2017
June 15, 2021
July 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SVd/Vd Arm: Progression-free Survival (PFS) as Assessed by Independent Review Committee (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%).
From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months)
Secondary Outcomes (11)
SVd/Vd Arm: Overall Response Rate (ORR) as Assessed by IRC
From date of randomization until disease progression or initiating a new MM treatment (up to 33 months)
SVd/Vd Arm: Percentage of Participants With Response Rate of Very Good Partial Response (VGPR) or Better Based on IRC Assessment
From date of randomization until confirmed PD or initiating a new MM treatment (up to 33 months)
SVd/Vd Arm: Number of Participants With at Least One Grade Greater Than or Equal to [>=] 2 Peripheral Neuropathy Events
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)
SVd/Vd Arm: Overall Survival (OS)
From date of randomization to the date of death or censored date, whichever occurred first (up to 45 months)
SVd/Vd Arm: Duration of Response (DOR) as Assessed by IRC
From the first documentation of response to the first documentation of PD or death, whichever occurred first (up to 45 months)
- +6 more secondary outcomes
Study Arms (4)
SVd Arm: Selinexor + Bortezomib + Dexamethasone
EXPERIMENTALParticipants 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.
Vd Arm: Bortezomib + Dexamethasone
EXPERIMENTALParticipants 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.
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
EXPERIMENTALParticipants 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.
SdX Arm: Selinexor + Dexamethasone
EXPERIMENTALParticipants 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.
Interventions
oral 100 mg dose
subcutaneous dose of 1.3 mg/m2
oral dose of 20mg
Eligibility Criteria
You may qualify if:
- 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 (normal FLC ratio: 0.26 to 1.65).
- 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. Patients with chronic, stable Grade 2 non-hematological toxicities may be included following approval from the Medical Monitor.
- Adequate hepatic function within 28 days prior to C1D1.
- +11 more criteria
You may not qualify if:
- 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. Cancer treated with curative intent for \>5 years previously and without evidence of recurrence will be allowed.
- 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.
- 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.
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (157)
Boca Raton Clinical Research (BRCR) Medical Center
Plantation, Florida, 33324, United States
Emory University
Atlanta, Georgia, 30322, United States
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96817, United States
McFarland Clinic
Ames, Iowa, 50010, United States
Stormont Vail Health Care (Cotton O'Neil Cancer Center )
Topeka, Kansas, 66606, United States
Commonwealth Hematology
Danville, Kentucky, 40422, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Central Care Cancer Center
Bolivar, Missouri, 65613, United States
The Valley Hospital Luckow Pavilion
Paramus, New Jersey, 07652, United States
Mount Sinai
New York, New York, 10029, United States
The Cancer Institute at St. Francis Hospital
Roslyn, New York, 11576, United States
Novant-Forsyth Memorial Hospital
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati Health
Cincinnati, Ohio, 45267, United States
Southwest Cancer Center of Oklahoma
Lawton, Oklahoma, 73505, United States
Kaiser Permanente Northwest OR
Portland, Oregon, 97210, United States
SCOR AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Prairie Lakes Healthcare
Watertown, South Dakota, 57201, United States
Baylor Sammons Cancer Center
Dallas, Texas, 75246, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Mater Misericordiae Limited and Mater Medical Research
South Brisbane, Queensland, 4101, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
Innsbruck, Austria
University Hospital Krems, Department of Internal Medicine II
Krems, Austria
Medical University of Vienna
Vienna, 1090, Austria
General Hospital Hietzing
Vienna, 1130, Austria
Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology
Vienna, 1160, Austria
Jules Bordet Institute
Brussels, 1000, Belgium
UCL Saint-Luc
Brussels, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
General Hospital Delta
Roeselare, 8800, Belgium
St. Augustinus Hospital
Wilrijk, 2610, Belgium
University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology
Plovdiv, 4002, Bulgaria
University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology
Sofia, 1431, Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology
Sofia, 1756, Bulgaria
Tom Baker Cancer Center/ Alberta Health Services
Calgary, Alberta, T2N 4Z6, Canada
Cross Cancer Institute / University of Alberta
Edmonton, Alberta, T6G 1Z2, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 2Y9, Canada
North East Cancer Centre Sudbury
Greater Sudbury, Ontario, P3E 5J1, Canada
Princess Margaret Cancer Research
Toronto, Ontario, M5G 1X5, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
Royal Victoria Hospital / McGill University
Montreal, Quebec, H3A 1A1, Canada
L'Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6, Canada
Saskatchewan Cancer Agency-Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7TI, Canada
Saskatoon Cancer Center
Saskatoon, Saskatchewan, S7N 4H4, Canada
General University Hospital in Prague
Prague, Prague, 128 08, Czechia
University Hopsital Brno
Brno, 625 00, Czechia
University Hospital Hradec Kralove
Hradec Králové, 500 05, Czechia
University Hospital Olomouc
Olomouc, 775 20, Czechia
University Hospital Ostrava, Dept. of Hematooncology
Ostrava, 708 52, Czechia
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
Prague, 100 34, Czechia
Hospital Center Departmental La Roche-Sur-Yon
La Roche-sur-Yon, 85925, France
Claude Huriez Hospital
Lille, 59037, France
South Lyon Hospital Center
Lyon, 69002, France
Brabois Adults Hospital, University Hospital Center of Nancy
Nancy, 54511, France
Nantes University Hospital Center
Nantes, 44093, France
Saint-Louis Hospital
Paris, 75475, France
Miletrie Hospital, University Hospital Center of Poitiers
Poitiers, 86021, France
Necker Children's Hospital, Department of Adult Hematology
Paris, Île-de-France Region, 75015, France
University Hospital Freiburg, Department of Internal Medicine I
Freiburg im Breisgau, Baden-Wurttemberg, D-79106, Germany
Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3
Leverkusen, North Rhine Westfalia, 51375, Germany
Group Practice for Hematology and Oncology
Dresden, Saxony, 1307, Germany
Alexandra General Hospital, Therapeutic Clinic
Athens, 11528, Greece
General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma
Athens, Greece
University General Hospital of Patra
Pátrai, Greece
Theageneion Cancer Hospital, Hematology Department
Thessaloniki, 54639, Greece
Semmelweis University, 1st Department of Internal Medicine
Budapest, H-1083, Hungary
Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation
Budapest, H-1097, Hungary
Semmelweis University, 3rd Department of Internal Medicine
Budapest, H-1125, Hungary
Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine
Kaposvár, 7400, Hungary
Medical Center of the University of Pecs, Department of Hematology
Pécs, 7624, Hungary
Regional Cancer Centre
Patna, Bihar, 800014, India
Regional Cancer Centre
Thiruvananthapuram, Kerala, 695011, India
Prince Aly Khan Hospital
Mumbai, Maharashta, 400010, India
Jaslok Hospital and Research Centre
Mumbai, Maharashta, 400026, India
Bhaktivedanta Hospital
Thane, Maharashtra, 401107, India
IMS & SUM Hospital
Bhubaneswar, Odisha, 751003, India
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, Punjab, 160012, India
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001, India
Cancer Institute
Chennai, Tamil Nadu, 600020, India
SRM Institute of Medical Sciences
Chennai, Tamil Nadu, 600026, India
Saveetha Medical College Hospital
Chennai, Tamil Nadu, 602105, India
G. Kuppuswamy Naidu Hospital
Coimbatore, Tamil Nadu, 641037, India
Asviratham Speciality Hospital
Madurai, Tamil Nadu, 625020, India
Meenakshi Mission Hospital
Madurai, Tamil Nadu, 625107, India
Yashoda Hospital
Hyderabad, Telangana, 500082, India
King George's Medical University
Lucknow, Uttar Pradesh, 226003, India
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, West Bengal, 700094, India
Nil Ratan Sircar (NRS) Medical College
Kolkata, West Bengal, 700120, India
TATA Memorial Centre
Kolkata, West Bengal, 700160, India
Rajiv Gandhi Cancer Hospital
New Delhi, 110085, India
Barzilai Medical Center
Ashkelon, 7830604, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Hospital Santa Maria of Terni
Terni, Umbria, 05100, Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ancona, 60131, Italy
ASST Papa Giovanni XXIII
Bergamo, 24127, Italy
Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo
Bologna, 40138, Italy
University Hospital Careggi, Department of Hematology
Florence, 50134, Italy
University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology
Genoa, 16132, Italy
Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit
Milan, 20162, Italy
Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center
Rome, 00161, Italy
University Hospital San Giovanni Battista of Turin
Turin, 10126, Italy
Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology
Bydgoszcz, 85-168, Poland
Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology
Chorzów, 41-500, Poland
University Hospital in Krakow, Teaching Unit of the Hematology Department
Krakow, 31-501, Poland
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology
Lodz, 93-513, Poland
Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation
Lublin, 20-081, Poland
St. John of Dukla Oncology Center of Lublin, Department of Hematology
Lublin, 20-090, Poland
Military Institute of Medicine, Department of Internal Medicine and Hematology
Warsaw, 04-141, Poland
Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department
Brasov, 500366, Romania
Colentina Clinical Hospital, Department of Hematology
Bucharest, 020125, Romania
Bucharest University Emergency Hospital, Department of Hematology
Bucharest, 050098, Romania
S.P. Botkin City Clinical Hospital
Moscow, 125284, Russia
N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways
Moscow, 129128, Russia
First I.P. Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197022, Russia
V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1
Saint Petersburg, 197341, Russia
Clinical Center of Serbia, Clinic of Hematology
Belgrade, 11000, Serbia
Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology
Belgrade, 11000, Serbia
Clinical Center Kragujevac, Clinic of Hematology
Kragujevac, 34 000, Serbia
Clinical Center Nis, Clinic of Hematology and Clinical Immunology
Niš, 18 000, Serbia
Clinical Center of Vojvodina, Clinic of Hematology
Novi Sad, 21 000, Serbia
University Hospital of the Canary Islands
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Catalan Institute of Oncology (ICO) Badalona
Badalona, 08916, Spain
University Hospital of Vall d'Hebron
Barcelona, 08035, Spain
University Hospital Infanta Leonor, Department of Hematology
Madrid, 28301, Spain
University Clinical Hospital of Salamanca, Department of Hematology
Salamanca, 37007, Spain
University Hospital Virgen del Rocio (HUVR)
Seville, 41013, Spain
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
Cherkasy, 18009, Ukraine
City Clinical Hospital No.4 of Dnipro City Council, City hematology center
Dnipropetrovsk, Ukraine
BMT Kiev Center
Kiev, Ukraine
Kiev Cancer Institute
Kiev, Ukraine
Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group
Lviv, 79044, Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology
Vinnytsia, 21018, Ukraine
O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards
Zhytomyr, 10008, Ukraine
Belfast Heatlh & Social Care Trust Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB, United Kingdom
NHS Tayside Ninewells Hospital
Dundee, Scotland, DD1 9SY, United Kingdom
Cardiff & Vale University Health Board University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
The Leeds Teaching Hospitals NHS Trust St. James University Hospital
Leeds, LS9 7TF, United Kingdom
University Hospitals of Leicester NHS Trust Royal Leicester Infirmary
Leicester, LE1 5WW, United Kingdom
Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
London North West Healthcare NHS Trust Northwick Park Hospital
London, HA1 3UJ, United Kingdom
University College London
London, NW3 2PF, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital
London, W12 0HS, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
The Royal Wolverhampton NHS Trust New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (7)
Jagannath S, Delimpasi S, Grosicki S, Van Domelen DR, Bentur OS, Spicka I, Dimopoulos MA. Association of Selinexor Dose Reductions With Clinical Outcomes in the BOSTON Study. Clin Lymphoma Myeloma Leuk. 2023 Dec;23(12):917-923.e3. doi: 10.1016/j.clml.2023.08.018. Epub 2023 Aug 29.
PMID: 37743180DERIVEDSchiller GJ, Lipe BC, Bahlis NJ, Tuchman SA, Bensinger WI, Sutherland HJ, Lentzsch S, Baljevic M, White D, Kotb R, Chen CI, Rossi A, Biran N, LeBlanc R, Grosicki S, Martelli M, Gunsilius E, Spicka I, Stevens DA, Facon T, Mesa MG, Zhang C, Van Domelen DR, Bentur OS, Gasparetto C. Selinexor-Based Triplet Regimens in Patients With Multiple Myeloma Previously Treated With Anti-CD38 Monoclonal Antibodies. Clin Lymphoma Myeloma Leuk. 2023 Sep;23(9):e286-e296.e4. doi: 10.1016/j.clml.2023.06.001. Epub 2023 Jun 5.
PMID: 37393120DERIVEDDelimpasi 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.
PMID: 34882831DERIVEDRichard 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.
PMID: 34062004DERIVEDMateos 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.
PMID: 33849608DERIVEDAuner 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.
PMID: 33755235DERIVEDGrosicki 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.
PMID: 33189178DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karyopharm Medical Information
- Organization
- Karyopharm Therapeutics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2017
First Posted
April 12, 2017
Study Start
May 24, 2017
Primary Completion
February 18, 2020
Study Completion
May 12, 2022
Last Updated
August 21, 2024
Results First Posted
July 8, 2021
Record last verified: 2024-07