Clinical trial NCT03110562: Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Relapsed or Refractory Multiple Myeloma
RRMM
Bortezomib
Dexamethasone
Lead sponsor: Karyopharm Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary part is parallel (SVd vs Vd treatment arm). Participants who received Vd were allowed to cross-over to receive either SVd or SdX treatment arm.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: SVd/Vd Arm: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
timeFrame: From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months)
Secondary outcomes:
measure: SVd/Vd Arm: Overall Response Rate (ORR) as Assessed by IRC
timeFrame: From date of randomization until disease progression or initiating a new MM treatment (up to 33 months)
measure: SVd/Vd Arm: Percentage of Participants With Response Rate of Very Good Partial Response (VGPR) or Better Based on IRC Assessment
timeFrame: From date of randomization until confirmed PD or initiating a new MM treatment (up to 33 months)
measure: SVd/Vd Arm: Number of Participants With at Least One Grade Greater Than or Equal to [>=] 2 Peripheral Neuropathy Events
timeFrame: 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)
measure: SVd/Vd Arm: Overall Survival (OS)
timeFrame: From date of randomization to the date of death or censored date, whichever occurred first (up to 45 months)
measure: SVd/Vd Arm: Duration of Response (DOR) as Assessed by IRC
timeFrame: From the first documentation of response to the first documentation of PD or death, whichever occurred first (up to 45 months)
measure: SVdX Arm: Overall Response Rate (ORR1) as Assessed by IRC During SVdX Treatment
timeFrame: From date of first SVdX treatment until disease progression or initiating a new MM treatment (up to 33 months)
measure: SVdX Arm: Progression Free Survival1 (PFS1) as Assessed by IRC During SVdX Treatment
timeFrame: From date of first SVdX treatment until IRC-confirmed documented PD or death or censored date, whichever occurred first (up to 33 months)
measure: SVd/Vd Arm: Time-to-next-treatment (TTNT) in Participants Randomized to the SVd and Vd Arm Who Received Treatment After SVd/Vd
timeFrame: From date of randomization to start of next anti-MM treatment or death, whichever occurred first (up to 33 months)
measure: SVd/Vd Arm: Time To Response (TTR) in Participants Randomized to the SVd and Vd Arm
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: Svd Arm: Baseline up to End of treatment (EOT) (at Day 820); Vd Arm: Baseline up to EOT (at Day 848)
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Boca Raton Clinical Research (BRCR) Medical Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii
state: Hawaii
city: Ames
country: United States
facility: McFarland Clinic
state: Iowa
city: Topeka
country: United States
facility: Stormont Vail Health Care (Cotton O'Neil Cancer Center )
state: Kansas
city: Danville
country: United States
facility: Commonwealth Hematology
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Bolivar
country: United States
facility: Central Care Cancer Center
state: Missouri
city: Paramus
country: United States
facility: The Valley Hospital Luckow Pavilion
state: New Jersey
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Roslyn
country: United States
facility: The Cancer Institute at St. Francis Hospital
state: New York
city: Winston-Salem
country: United States
facility: Novant-Forsyth Memorial Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Health
state: Ohio
city: Lawton
country: United States
facility: Southwest Cancer Center of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Northwest OR
state: Oregon
city: Anderson
country: United States
facility: SCOR AnMed Health Cancer Center
state: South Carolina
city: Watertown
country: United States
facility: Prairie Lakes Healthcare
state: South Dakota
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited and Mater Medical Research
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
city: Krems
country: Austria
facility: University Hospital Krems, Department of Internal Medicine II
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: General Hospital Hietzing
city: Vienna
country: Austria
facility: Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology
city: Brussels
country: Belgium
facility: Jules Bordet Institute
city: Brussels
country: Belgium
facility: UCL Saint-Luc
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Roeselare
country: Belgium
facility: General Hospital Delta
city: Wilrijk
country: Belgium
facility: St. Augustinus Hospital
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology
city: Calgary
country: Canada
facility: Tom Baker Cancer Center/ Alberta Health Services
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute / University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Sudbury
country: Canada
facility: North East Cancer Centre Sudbury
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Research
state: Ontario
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital / McGill University
state: Quebec
city: Quebec City
country: Canada
facility: L'Hôtel-Dieu de Québec
state: Quebec
city: Regina
country: Canada
facility: Saskatchewan Cancer Agency-Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center
state: Saskatchewan
city: Praha 2
country: Czechia
facility: General University Hospital in Prague
state: Prague
city: Brno
country: Czechia
facility: University Hopsital Brno
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Ostrava
country: Czechia
facility: University Hospital Ostrava, Dept. of Hematooncology
city: Prague
country: Czechia
facility: University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
city: Paris
country: France
facility: Necker Children's Hospital, Department of Adult Hematology
state: Ile De France
city: La Roche-sur-Yon
country: France
facility: Hospital Center Departmental La Roche-Sur-Yon
city: Lille
country: France
facility: Claude Huriez Hospital
city: Lyon
country: France
facility: South Lyon Hospital Center
city: Nancy
country: France
facility: Brabois Adults Hospital, University Hospital Center of Nancy
city: Nantes
country: France
facility: Nantes University Hospital Center
city: Paris
country: France
facility: Saint-Louis Hospital
city: Poitiers
country: France
facility: Miletrie Hospital, University Hospital Center of Poitiers
city: Freiburg
country: Germany
facility: University Hospital Freiburg, Department of Internal Medicine I
state: Baden-Wuerttemberg
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3
state: North Rhine Westfalia
city: Dresden
country: Germany
facility: Group Practice for Hematology and Oncology
state: Saxony
city: Athens
country: Greece
facility: Alexandra General Hospital, Therapeutic Clinic
city: Athens
country: Greece
facility: General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma
city: Pátra
country: Greece
facility: University General Hospital of Patra
city: Thessaloníki
country: Greece
facility: Theageneion Cancer Hospital, Hematology Department
city: Budapest
country: Hungary
facility: Semmelweis University, 1st Department of Internal Medicine
city: Budapest
country: Hungary
facility: Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation
city: Budapest
country: Hungary
facility: Semmelweis University, 3rd Department of Internal Medicine
city: Kaposvar
country: Hungary
facility: Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine
city: Pecs
country: Hungary
facility: Medical Center of the University of Pecs, Department of Hematology
city: Patna
country: India
facility: Regional Cancer Centre
state: Bihar
city: Thiruvananthapuram
country: India
facility: Regional Cancer Centre
state: Kerala
city: Mumbai
country: India
facility: Prince Aly Khan Hospital
state: Maharashta
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
state: Maharashta
city: Thane
country: India
facility: Bhaktivedanta Hospital
state: Maharashtra
city: Bhubaneswar
country: India
facility: IMS & SUM Hospital
state: Odisha
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research (PGIMER)
state: Punjab
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
state: Punjab
city: Chennai
country: India
facility: Cancer Institute
state: Tamil Nadu
city: Chennai
country: India
facility: SRM Institute of Medical Sciences
state: Tamil Nadu
city: Chennai
country: India
facility: Saveetha Medical College Hospital
state: Tamil Nadu
city: Coimbatore
country: India
facility: G. Kuppuswamy Naidu Hospital
state: Tamil Nadu
city: Madurai
country: India
facility: Asviratham Speciality Hospital
state: Tamil Nadu
city: Madurai
country: India
facility: Meenakshi Mission Hospital
state: Tamil Nadu
city: Hyderabad
country: India
facility: Yashoda Hospital
state: Telengana
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
city: Kolkata
country: India
facility: Netaji Subhash Chandra Bose Cancer Research Institute
state: West Bengal
city: Kolkata
country: India
facility: Nil Ratan Sircar (NRS) Medical College
state: West Bengal
city: Kolkata
country: India
facility: TATA Memorial Centre
state: West Bengal
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petaẖ Tiqwa
country: Israel
facility: Rabin Medical Center
city: Terni
country: Italy
facility: Hospital Santa Maria of Terni
state: Umbria
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo
city: Florence
country: Italy
facility: University Hospital Careggi, Department of Hematology
city: Genoa
country: Italy
facility: University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology
city: Milan
country: Italy
facility: Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit
city: Rome
country: Italy
facility: Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center
city: Turin
country: Italy
facility: University Hospital San Giovanni Battista of Turin
city: Bydgoszcz
country: Poland
facility: Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology
city: Chorzow
country: Poland
facility: Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology
city: Krakow
country: Poland
facility: University Hospital in Krakow, Teaching Unit of the Hematology Department
city: Lublin
country: Poland
facility: Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation
city: Lublin
country: Poland
facility: St. John of Dukla Oncology Center of Lublin, Department of Hematology
city: Warsaw
country: Poland
facility: Military Institute of Medicine, Department of Internal Medicine and Hematology
city: Łódź
country: Poland
facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology
city: Braşov
country: Romania
facility: Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital, Department of Hematology
city: Bucharest
country: Romania
facility: Bucharest University Emergency Hospital, Department of Hematology
city: Moscow
country: Russian Federation
facility: S.P. Botkin City Clinical Hospital
city: Moscow
country: Russian Federation
facility: N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways
city: Saint Petersburg
country: Russian Federation
facility: First I.P. Pavlov State Medical University of St. Petersburg
city: Saint Petersburg
country: Russian Federation
facility: V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Clinic of Hematology
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac, Clinic of Hematology
city: Nis
country: Serbia
facility: Clinical Center Nis, Clinic of Hematology and Clinical Immunology
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina, Clinic of Hematology
city: La Laguna
country: Spain
facility: University Hospital of the Canary Islands
state: Santa Cruz De Tenerife
city: Badalona
country: Spain
facility: Catalan Institute of Oncology (ICO) Badalona
city: Barcelona
country: Spain
facility: University Hospital of Vall d'Hebron
city: Madrid
country: Spain
facility: University Hospital Infanta Leonor, Department of Hematology
city: Salamanca
country: Spain
facility: University Clinical Hospital of Salamanca, Department of Hematology
city: Seville
country: Spain
facility: University Hospital Virgen del Rocio (HUVR)
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
city: Dnipropetrovsk
country: Ukraine
facility: City Clinical Hospital No.4 of Dnipro City Council, City hematology center
city: Kiev
country: Ukraine
facility: BMT Kiev Center
city: Kiev
country: Ukraine
facility: Kiev Cancer Institute
city: Lviv
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group
city: Vinnytsia
country: Ukraine
facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology
city: Zhytomyr
country: Ukraine
facility: O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards
city: Belfast
country: United Kingdom
facility: Belfast Heatlh & Social Care Trust Belfast City Hospital
state: Northern Ireland
city: Dundee
country: United Kingdom
facility: NHS Tayside Ninewells Hospital
state: Scotland
city: Cardiff
country: United Kingdom
facility: Cardiff & Vale University Health Board University Hospital of Wales
state: Wales
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust St. James University Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust Royal Leicester Infirmary
city: Liverpool
country: United Kingdom
facility: Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: London North West Healthcare NHS Trust Northwick Park Hospital
city: London
country: United Kingdom
facility: University College London
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust New Cross Hospital
Study officials:
References:
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.
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