AzTrials
AzTrials

Multiple MyelomaPhase 3BOSTONNCT03110562

Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma

A Phase 3 study testing Selinexor, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Karyopharm Therapeutics Inc at 157 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Selinexor, Bortezomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
157 sitesin 21 countries
Study dates
24 May 2017to 12 May 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal to <2 × ULN.
  • 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).
  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

157 sites in 21 countries.

157 sites in 21 countries

United States20 sites

  • McFarland Clinic

    Ames, Iowa, 50010

  • SCOR AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Central Care Cancer Center

    Bolivar, Missouri, 65613

  • University of Cincinnati Health

    Cincinnati, Ohio, 45267

  • Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Commonwealth Hematology

    Danville, Kentucky, 40422

  • Kaiser Permanente Hawaii

    Honolulu, Hawaii, 96817

  • Southwest Cancer Center of Oklahoma

    Lawton, Oklahoma, 73505

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Mount Sinai

    New York, New York, 10029

  • The Valley Hospital Luckow Pavilion

    Paramus, New Jersey, 07652

  • Boca Raton Clinical Research (BRCR) Medical Center

    Plantation, Florida, 33324

  • Kaiser Permanente Northwest OR

    Portland, Oregon, 97210

  • The Cancer Institute at St. Francis Hospital

    Roslyn, New York, 11576

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

    Topeka, Kansas, 66606

  • Prairie Lakes Healthcare

    Watertown, South Dakota, 57201

  • Novant-Forsyth Memorial Hospital

    Winston-Salem, North Carolina, 27103

Other trials in United States

India20 sites

  • IMS & SUM Hospital

    Bhubaneswar, Odisha, 751003

  • Postgraduate Institute of Medical Education & Research (PGIMER)

    Chandigarh, Punjab, 160012

  • Cancer Institute

    Chennai, Tamil Nadu, 600020

  • SRM Institute of Medical Sciences

    Chennai, Tamil Nadu, 600026

  • Saveetha Medical College Hospital

    Chennai, Tamil Nadu, 602105

  • G. Kuppuswamy Naidu Hospital

    Coimbatore, Tamil Nadu, 641037

  • Yashoda Hospital

    Hyderabad, Telangana, 500082

  • Netaji Subhash Chandra Bose Cancer Research Institute

    Kolkata, West Bengal, 700094

  • Nil Ratan Sircar (NRS) Medical College

    Kolkata, West Bengal, 700120

  • TATA Memorial Centre

    Kolkata, West Bengal, 700160

  • King George's Medical University

    Lucknow, Uttar Pradesh, 226003

  • Dayanand Medical College & Hospital

    Ludhiana, Punjab, 141001

  • Asviratham Speciality Hospital

    Madurai, Tamil Nadu, 625020

  • Meenakshi Mission Hospital

    Madurai, Tamil Nadu, 625107

  • Prince Aly Khan Hospital

    Mumbai, Maharashta, 400010

  • Jaslok Hospital and Research Centre

    Mumbai, Maharashta, 400026

  • Rajiv Gandhi Cancer Hospital

    New Delhi, 110085

  • Regional Cancer Centre

    Patna, Bihar, 800014

  • Bhaktivedanta Hospital

    Thane, Maharashtra, 401107

  • Regional Cancer Centre

    Thiruvananthapuram, Kerala, 695011

Other trials in India

United Kingdom14 sites

  • Belfast Heatlh & Social Care Trust Belfast City Hospital

    Belfast, Northern Ireland, BT9 7AB

  • University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Cardiff & Vale University Health Board University Hospital of Wales

    Cardiff, Wales, CF14 4XW

  • NHS Tayside Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • The Leeds Teaching Hospitals NHS Trust St. James University Hospital

    Leeds, LS9 7TF

  • University Hospitals of Leicester NHS Trust Royal Leicester Infirmary

    Leicester, LE1 5WW

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

    Liverpool, L7 8XP

  • London North West Healthcare NHS Trust Northwick Park Hospital

    London, HA1 3UJ

  • University College London

    London, NW3 2PF

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

  • Imperial College Healthcare NHS Trust Hammersmith Hospital

    London, W12 0HS

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • The Royal Wolverhampton NHS Trust New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Canada11 sites

  • Tom Baker Cancer Center/ Alberta Health Services

    Calgary, Alberta, T2N 4Z6

  • Cross Cancer Institute / University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • North East Cancer Centre Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 2Y9

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Royal Victoria Hospital / McGill University

    Montreal, Quebec, H3A 1A1

  • L'Hôtel-Dieu de Québec

    Québec, Quebec, G1R 2J6

  • Saskatchewan Cancer Agency-Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7TI

  • Saskatoon Cancer Center

    Saskatoon, Saskatchewan, S7N 4H4

  • Princess Margaret Cancer Research

    Toronto, Ontario, M5G 1X5

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Italy9 sites

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti

    Ancona, 60131

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

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

    Bologna, 40138

  • University Hospital Careggi, Department of Hematology

    Florence, 50134

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

    Genoa, 16132

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

    Milan, 20162

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

    Rome, 00161

  • Hospital Santa Maria of Terni

    Terni, Umbria, 05100

  • University Hospital San Giovanni Battista of Turin

    Turin, 10126

Other trials in Italy

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Mater Misericordiae Limited and Mater Medical Research

    South Brisbane, Queensland, 4101

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

France8 sites

  • Hospital Center Departmental La Roche-Sur-Yon

    La Roche-sur-Yon, 85925

  • Claude Huriez Hospital

    Lille, 59037

  • South Lyon Hospital Center

    Lyon, 69002

  • Brabois Adults Hospital, University Hospital Center of Nancy

    Nancy, 54511

  • Nantes University Hospital Center

    Nantes, 44093

  • Saint-Louis Hospital

    Paris, 75475

  • Necker Children's Hospital, Department of Adult Hematology

    Paris, Île-de-France Region, 75015

  • Miletrie Hospital, University Hospital Center of Poitiers

    Poitiers, 86021

Other trials in France

Poland7 sites

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

    Bydgoszcz, 85-168

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

    Chorzów, 41-500

  • University Hospital in Krakow, Teaching Unit of the Hematology Department

    Krakow, 31-501

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

    Lodz, 93-513

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

    Lublin, 20-081

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

    Lublin, 20-090

  • Military Institute of Medicine, Department of Internal Medicine and Hematology

    Warsaw, 04-141

Other trials in Poland

Ukraine7 sites

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

    Cherkasy, 18009

  • City Clinical Hospital No.4 of Dnipro City Council, City hematology center

    Dnipropetrovsk

  • BMT Kiev Center

    Kiev

  • Kiev Cancer Institute

    Kiev

  • Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group

    Lviv, 79044

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

    Vinnytsia, 21018

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

    Zhytomyr, 10008

Other trials in Ukraine

Czechia6 sites

  • University Hopsital Brno

    Brno, 625 00

  • University Hospital Hradec Kralove

    Hradec Králové, 500 05

  • University Hospital Olomouc

    Olomouc, 775 20

  • University Hospital Ostrava, Dept. of Hematooncology

    Ostrava, 708 52

  • General University Hospital in Prague

    Prague, Prague, 128 08

  • University Hospital Kralovske Vinohrady, Clinic of Internal Hematology

    Prague, 100 34

Other trials in Czechia

Spain6 sites

  • Catalan Institute of Oncology (ICO) Badalona

    Badalona, 08916

  • University Hospital of Vall d'Hebron

    Barcelona, 08035

  • University Hospital Infanta Leonor, Department of Hematology

    Madrid, 28301

  • University Clinical Hospital of Salamanca, Department of Hematology

    Salamanca, 37007

  • University Hospital of the Canary Islands

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • University Hospital Virgen del Rocio (HUVR)

    Seville, 41013

Other trials in Spain

Austria5 sites

  • Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)

    Innsbruck

  • University Hospital Krems, Department of Internal Medicine II

    Krems

  • Medical University of Vienna

    Vienna, 1090

  • General Hospital Hietzing

    Vienna, 1130

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

    Vienna, 1160

Other trials in Austria

Belgium5 sites

  • Jules Bordet Institute

    Brussels, 1000

  • UCL Saint-Luc

    Brussels

  • University Hospital Ghent

    Ghent, 9000

  • General Hospital Delta

    Roeselare, 8800

  • St. Augustinus Hospital

    Wilrijk, 2610

Other trials in Belgium

Hungary5 sites

  • Semmelweis University, 1st Department of Internal Medicine

    Budapest, H-1083

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

    Budapest, H-1097

  • Semmelweis University, 3rd Department of Internal Medicine

    Budapest, H-1125

  • Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine

    Kaposvár, 7400

  • Medical Center of the University of Pecs, Department of Hematology

    Pécs, 7624

Other trials in Hungary

Serbia5 sites

  • Clinical Center of Serbia, Clinic of Hematology

    Belgrade, 11000

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

    Belgrade, 11000

  • Clinical Center Kragujevac, Clinic of Hematology

    Kragujevac, 34 000

  • Clinical Center Nis, Clinic of Hematology and Clinical Immunology

    Niš, 18 000

  • Clinical Center of Vojvodina, Clinic of Hematology

    Novi Sad, 21 000

Other trials in Serbia

Greece4 sites

  • Alexandra General Hospital, Therapeutic Clinic

    Athens, 11528

  • General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma

    Athens

  • University General Hospital of Patra

    Pátrai

  • Theageneion Cancer Hospital, Hematology Department

    Thessaloniki, 54639

Other trials in Greece

Israel4 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah Medical Center

    Jerusalem

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

Russia4 sites

  • S.P. Botkin City Clinical Hospital

    Moscow, 125284

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

    Moscow, 129128

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

    Saint Petersburg, 197022

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

    Saint Petersburg, 197341

Other trials in Russia

Bulgaria3 sites

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

    Plovdiv, 4002

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

    Sofia, 1431

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

    Sofia, 1756

Other trials in Bulgaria

Germany3 sites

  • Group Practice for Hematology and Oncology

    Dresden, Saxony, 1307

  • University Hospital Freiburg, Department of Internal Medicine I

    Freiburg im Breisgau, Baden-Wurttemberg, D-79106

  • Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3

    Leverkusen, North Rhine Westfalia, 51375

Other trials in Germany

Romania3 sites

  • Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department

    Brasov, 500366

  • Colentina Clinical Hospital, Department of Hematology

    Bucharest, 020125

  • Bucharest University Emergency Hospital, Department of Hematology

    Bucharest, 050098

Other trials in Romania

About this study

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)

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.

Being tested
Selinexor, Bortezomib, Dexamethasone
Keywords
Relapsed or Refractory Multiple Myeloma, RRMM, Bortezomib, Dexamethasone
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelinexorDrug

    oral 100 mg dose

  • BortezomibDrug

    Also called Velcade®

    subcutaneous dose of 1.3 mg/m2

  • DexamethasoneDrug

    oral dose of 20mg

Study groups in NCT03110562
Study groupRoleWhat they receive
SVd Arm: Selinexor + Bortezomib + DexamethasoneExperimentalParticipants 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.
Receives: Drug: Selinexor; Drug: Bortezomib; Drug: Dexamethasone
Vd Arm: Bortezomib + DexamethasoneExperimentalParticipants 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.
Receives: Drug: Bortezomib; Drug: Dexamethasone
SVdX Arm: Selinexor + Bortezomib + DexamethasoneExperimentalParticipants 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.
Receives: Drug: Selinexor; Drug: Bortezomib; Drug: Dexamethasone
SdX Arm: Selinexor + DexamethasoneExperimentalParticipants 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.
Receives: Drug: Selinexor; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%).

    Measured: From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months)

Secondary outcomes (11)

  1. SVd/Vd Arm: Overall Response Rate (ORR) as Assessed by IRC

    ORR was defined as the percentage of the participants who achieved any confirmed partial response (PR) or better PR, complete response (CR), very good partial response (VGPR) or stringent complete response (sCR) based on the IRC's response outcome assessments, according to the International Myeloma Working Group (IMWG) response criteria, before IRC-confirmed PD or initiating a new MM treatment. PR: >= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <= 5% plasma cells in bone marrow; or stringent complete response (sCR): CR as defined as Normal free light chain (FLC) ratio + Absence of clonal cells by immunohistochemistry.

    Measured: From date of randomization until disease progression or initiating a new MM treatment (up to 33 months)

  2. SVd/Vd Arm: Percentage of Participants With Response Rate of Very Good Partial Response (VGPR) or Better Based on IRC Assessment

    Response rate was defined as percentage of participants with responses of VGPR, at any time prior to IRC-confirmed PD or initiating a new MM treatment. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.

    Measured: From date of randomization until confirmed PD or initiating a new MM treatment (up to 33 months)

  3. SVd/Vd Arm: Number of Participants With at Least One Grade Greater Than or Equal to [>=] 2 Peripheral Neuropathy Events

    Peripheral neuropathy events was assessed using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. The grade ranges from Grade 1 (mild, asymptomatic, or mild symptoms) to Grade 5 (death related to an adverse event). Grade 2 indicates a moderate condition that may require minimal intervention and can limit certain daily activities. Grade 3 represents severe symptoms that are not immediately life-threatening but may lead to hospitalization and restrict self-care activities. Grade 4 denotes life-threatening consequences requiring urgent intervention. Number of participants experiencing at least one Grade >= 2 peripheral neuropathy event have been reported.

    Measured: 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)

  4. SVd/Vd Arm: Overall Survival (OS)

    OS was defined as the time from the date of randomization until either the date of death due to any cause or until the participant is lost to follow-up, for all participants.

    Measured: From date of randomization to the date of death or censored date, whichever occurred first (up to 45 months)

  5. SVd/Vd Arm: Duration of Response (DOR) as Assessed by IRC

    DOR was defined as the duration of time from the first occurrence of an IRC confirmed response of at least (>=) PR until the first date of IRC-confirmed PD or death due to any cause, whichever occurred first. PR: >= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hours; PD: Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >= 5 g/dL; Urine M-protein (absolute increase must be >= 200 mg per 24 hours). Analysis was performed using Kaplan-Meier method.

    Measured: From the first documentation of response to the first documentation of PD or death, whichever occurred first (up to 45 months)

  6. SVdX Arm: Overall Response Rate (ORR1) as Assessed by IRC During SVdX Treatment

    ORR was defined as the percentage of the participants who achieved a confirmed partial response or better (i.e., PR, VGPR, CR, or sCR) based on the IRC's response outcome assessments, according to the IMWG response criteria. PR: >=50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by >=90% or <200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; or sCR: CR as defined as Normal FLC ratio+ Absence of clonal cells in bone marrow biopsy by immunohistochemistry.

    Measured: From date of first SVdX treatment until disease progression or initiating a new MM treatment (up to 33 months)

  7. SVdX Arm: Progression Free Survival1 (PFS1) as Assessed by IRC During SVdX Treatment

    PFS1 is defined as the duration of time from the date of the first dose of the SVd treatment after crossover from the Vd arm until the first date of PD or death due to any cause, whichever occurred 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%).

    Measured: From date of first SVdX treatment until IRC-confirmed documented PD or death or censored date, whichever occurred first (up to 33 months)

  8. SVd/Vd Arm: Time-to-next-treatment (TTNT) in Participants Randomized to the SVd and Vd Arm Who Received Treatment After SVd/Vd

    TTNT is defined as the duration from date of randomization to start of next anti-MM treatment or death, whichever occurs first. For patients without an event, their follow-up time will be censored at the date of discontinuation from study, or last participating visit on or before database cutoff date, whichever occurs first.

    Measured: From date of randomization to start of next anti-MM treatment or death, whichever occurred first (up to 33 months)

  9. SVd/Vd Arm: Time To Response (TTR) in Participants Randomized to the SVd and Vd Arm

    TTR was defined as duration from randomization to the date of first IRC-confirmed PR or better (i.e., PR, VGPR, CR, or sCR) before IRC-confirmed PD or initiating a new MM treatment per IMWG response criteria. The participants who do not achieve IRC-confirmed PR or better response will be censored at the date of last disease assessment on or before database cutoff date. PR: >= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <= 5% plasma cells in bone marrow; or sCR: Normal free light chain (FLC) ratio + Absence of clonal cells by immunohistochemistry.

    Measured: 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)

  10. 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

    PFS 2 was defined as the duration of time from the date of the first dose of the treatment after SVd/Vd/SVdX until the first date of PD on treatment after SVd/Vd/SVdX or death due to any cause, whichever occurred 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%).

    Measured: 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)

  11. 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

    The EORTC QLQ-CIPN20 instrument is a 20-item QoL instrument, which has been developed to elicit patients' experience of symptoms and functional limitations related to CIPN. The QLQ-CIPN20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items) containing a 4-point Likert scale (1= not at all, 2= a little, 3= quite a bit, and 4= very much), participants indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). All scale scores are linearly converted to a total score with range of 0-100 scale, with higher scores indicating more symptom burden.

    Measured: Svd Arm: Baseline up to End of treatment (EOT) (at Day 820); Vd Arm: Baseline up to EOT (at Day 848)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start24 May 2017
  3. Primary completion18 Feb 2020
  4. Study completion12 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03110562
Sponsor's protocol ID
KCP-330-023
Acronym
BOSTON
Status last verified
Jul 2024
First submitted
7 Apr 2017
Last updated
21 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37743180

  • Schiller 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.

    PubMed 37393120

  • 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.

    PubMed 34882831

  • 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.

    PubMed 34062004

  • 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.

    PubMed 33849608

  • 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.

    PubMed 33755235

  • 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.

    PubMed 33189178

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selinexor, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Karyopharm Therapeutics Inc at 157 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, India, United Kingdom, Canada, Italy and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SVd/Vd Arm: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC) (time frame: From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03110562, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.

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