Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma

NCT ID: NCT03110562

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-24
• Study Completion Date: 2022-05-12

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m\^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: DRUG

oral 100 mg dose

Bortezomib

Intervention Type: DRUG

subcutaneous dose of 1.3 mg/m2

Dexamethasone

Intervention Type: DRUG

oral dose of 20mg

Vd Arm: Bortezomib + Dexamethasone

Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by greater than or equal to (\>=) 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

subcutaneous dose of 1.3 mg/m2

Dexamethasone

Intervention Type: DRUG

oral dose of 20mg

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: DRUG

oral 100 mg dose

Bortezomib

Intervention Type: DRUG

subcutaneous dose of 1.3 mg/m2

Dexamethasone

Intervention Type: DRUG

oral dose of 20mg

SdX Arm: Selinexor + Dexamethasone

Participants in the VD arm who had IRC-confirmed PD and were unable to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: DRUG

oral 100 mg dose

Dexamethasone

Intervention Type: DRUG

oral dose of 20mg

Interventions

Selinexor

oral 100 mg dose

Intervention Type: DRUG

Bortezomib

subcutaneous dose of 1.3 mg/m2

Intervention Type: DRUG

Dexamethasone

oral dose of 20mg

Intervention Type: DRUG

Other Intervention Names

Velcade®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karyopharm Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Boca Raton Clinical Research (BRCR) Medical Center

Plantation, Florida, United States

Emory University

Atlanta, Georgia, United States

Kaiser Permanente Hawaii

Honolulu, Hawaii, United States

McFarland Clinic

Ames, Iowa, United States

Stormont Vail Health Care (Cotton O'Neil Cancer Center )

Topeka, Kansas, United States

Commonwealth Hematology

Danville, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

Central Care Cancer Center

Bolivar, Missouri, United States

The Valley Hospital Luckow Pavilion

Paramus, New Jersey, United States

Mount Sinai

New York, New York, United States

The Cancer Institute at St. Francis Hospital

Roslyn, New York, United States

Novant-Forsyth Memorial Hospital

Winston-Salem, North Carolina, United States

University of Cincinnati Health

Cincinnati, Ohio, United States

Southwest Cancer Center of Oklahoma

Lawton, Oklahoma, United States

Kaiser Permanente Northwest OR

Portland, Oregon, United States

SCOR AnMed Health Cancer Center

Anderson, South Carolina, United States

Prairie Lakes Healthcare

Watertown, South Dakota, United States

Baylor Sammons Cancer Center

Dallas, Texas, United States

University of Texas Southwestern

Dallas, Texas, United States

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Mater Misericordiae Limited and Mater Medical Research

South Brisbane, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, 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, , Austria

General Hospital Hietzing

Vienna, , Austria

Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology

Vienna, , Austria

Jules Bordet Institute

Brussels, , Belgium

UCL Saint-Luc

Brussels, , Belgium

University Hospital Ghent

Ghent, , Belgium

General Hospital Delta

Roeselare, , Belgium

St. Augustinus Hospital

Wilrijk, , Belgium

University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology

Plovdiv, , Bulgaria

University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology

Sofia, , Bulgaria

Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology

Sofia, , Bulgaria

Tom Baker Cancer Center/ Alberta Health Services

Calgary, Alberta, Canada

Cross Cancer Institute / University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

North East Cancer Centre Sudbury

Greater Sudbury, Ontario, Canada

Princess Margaret Cancer Research

Toronto, Ontario, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Royal Victoria Hospital / McGill University

Montreal, Quebec, Canada

L'Hôtel-Dieu de Québec

Québec, Quebec, Canada

Saskatchewan Cancer Agency-Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Center

Saskatoon, Saskatchewan, Canada

General University Hospital in Prague

Prague, Prague, Czechia

University Hopsital Brno

Brno, , Czechia

University Hospital Hradec Kralove

Hradec Králové, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

University Hospital Ostrava, Dept. of Hematooncology

Ostrava, , Czechia

University Hospital Kralovske Vinohrady, Clinic of Internal Hematology

Prague, , Czechia

Hospital Center Departmental La Roche-Sur-Yon

La Roche-sur-Yon, , France

Claude Huriez Hospital

Lille, , France

South Lyon Hospital Center

Lyon, , France

Brabois Adults Hospital, University Hospital Center of Nancy

Nancy, , France

Nantes University Hospital Center

Nantes, , France

Saint-Louis Hospital

Paris, , France

Miletrie Hospital, University Hospital Center of Poitiers

Poitiers, , France

Necker Children's Hospital, Department of Adult Hematology

Paris, Île-de-France Region, France

University Hospital Freiburg, Department of Internal Medicine I

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3

Leverkusen, North Rhine Westfalia, Germany

Group Practice for Hematology and Oncology

Dresden, Saxony, Germany

Alexandra General Hospital, Therapeutic Clinic

Athens, , 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, , Greece

Semmelweis University, 1st Department of Internal Medicine

Budapest, , Hungary

Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation

Budapest, , Hungary

Semmelweis University, 3rd Department of Internal Medicine

Budapest, , Hungary

Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine

Kaposvár, , Hungary

Medical Center of the University of Pecs, Department of Hematology

Pécs, , Hungary

Regional Cancer Centre

Patna, Bihar, India

Regional Cancer Centre

Thiruvananthapuram, Kerala, India

Prince Aly Khan Hospital

Mumbai, Maharashta, India

Jaslok Hospital and Research Centre

Mumbai, Maharashta, India

Bhaktivedanta Hospital

Thāne, Maharashtra, India

IMS & SUM Hospital

Bhubaneswar, Odisha, India

Postgraduate Institute of Medical Education & Research (PGIMER)

Chandigarh, Punjab, India

Dayanand Medical College & Hospital

Ludhiana, Punjab, India

Cancer Institute

Chennai, Tamil Nadu, India

SRM Institute of Medical Sciences

Chennai, Tamil Nadu, India

Saveetha Medical College Hospital

Chennai, Tamil Nadu, India

G. Kuppuswamy Naidu Hospital

Coimbatore, Tamil Nadu, India

Asviratham Speciality Hospital

Madurai, Tamil Nadu, India

Meenakshi Mission Hospital

Madurai, Tamil Nadu, India

Yashoda Hospital

Hyderabad, Telangana, India

King George's Medical University

Lucknow, Uttar Pradesh, India

Netaji Subhash Chandra Bose Cancer Research Institute

Kolkata, West Bengal, India

Nil Ratan Sircar (NRS) Medical College

Kolkata, West Bengal, India

TATA Memorial Centre

Kolkata, West Bengal, India

Rajiv Gandhi Cancer Hospital

New Delhi, , India

Barzilai Medical Center

Ashkelon, , Israel

Rambam Health Care Campus

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Hospital Santa Maria of Terni

Terni, Umbria, Italy

Azienda Ospedaliero-Universitaria Ospedali Riuniti

Ancona, , Italy

ASST Papa Giovanni XXIII

Bergamo, , Italy

Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo

Bologna, , Italy

University Hospital Careggi, Department of Hematology

Florence, , Italy

University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology

Genoa, , Italy

Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit

Milan, , Italy

Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center

Rome, , Italy

University Hospital San Giovanni Battista of Turin

Turin, , Italy

Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology

Bydgoszcz, , Poland

Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology

Chorzów, , Poland

University Hospital in Krakow, Teaching Unit of the Hematology Department

Krakow, , Poland

Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology

Lodz, , Poland

Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation

Lublin, , Poland

St. John of Dukla Oncology Center of Lublin, Department of Hematology

Lublin, , Poland

Military Institute of Medicine, Department of Internal Medicine and Hematology

Warsaw, , Poland

Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department

Brasov, , Romania

Colentina Clinical Hospital, Department of Hematology

Bucharest, , Romania

Bucharest University Emergency Hospital, Department of Hematology

Bucharest, , Romania

S.P. Botkin City Clinical Hospital

Moscow, , Russia

N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways

Moscow, , Russia

First I.P. Pavlov State Medical University of St. Petersburg

Saint Petersburg, , Russia

V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1

Saint Petersburg, , Russia

Clinical Center of Serbia, Clinic of Hematology

Belgrade, , Serbia

Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology

Belgrade, , Serbia

Clinical Center Kragujevac, Clinic of Hematology

Kragujevac, , Serbia

Clinical Center Nis, Clinic of Hematology and Clinical Immunology

Niš, , Serbia

Clinical Center of Vojvodina, Clinic of Hematology

Novi Sad, , Serbia

University Hospital of the Canary Islands

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Catalan Institute of Oncology (ICO) Badalona

Badalona, , Spain

University Hospital of Vall d'Hebron

Barcelona, , Spain

University Hospital Infanta Leonor, Department of Hematology

Madrid, , Spain

University Clinical Hospital of Salamanca, Department of Hematology

Salamanca, , Spain

University Hospital Virgen del Rocio (HUVR)

Seville, , Spain

Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology

Cherkasy, , 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, , Ukraine

Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology

Vinnytsia, , Ukraine

O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards

Zhytomyr, , Ukraine

Belfast Heatlh & Social Care Trust Belfast City Hospital

Belfast, Northern Ireland, United Kingdom

NHS Tayside Ninewells Hospital

Dundee, Scotland, United Kingdom

Cardiff & Vale University Health Board University Hospital of Wales

Cardiff, Wales, United Kingdom

University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital

Birmingham, , United Kingdom

The Leeds Teaching Hospitals NHS Trust St. James University Hospital

Leeds, , United Kingdom

University Hospitals of Leicester NHS Trust Royal Leicester Infirmary

Leicester, , United Kingdom

Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital

Liverpool, , United Kingdom

London North West Healthcare NHS Trust Northwick Park Hospital

London, , United Kingdom

University College London

London, , United Kingdom

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Imperial College Healthcare NHS Trust Hammersmith Hospital

London, , United Kingdom

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

The Royal Wolverhampton NHS Trust New Cross Hospital

Wolverhampton, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Bulgaria; Canada; Czechia; France; Germany; Greece; Hungary; India; Israel; Italy; Poland; Romania; Russia; Serbia; Spain; Ukraine; United Kingdom

References

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Reference Type: DERIVED

PMID: 33755235 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33189178 (View on PubMed)

Provided Documents

Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Other Identifiers

KCP-330-023

Identifier Type: -

Identifier Source: org_study_id