Multiple Myeloma Clinical Trial

Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed MM with measurable disease per IMWG guidelines as defined by at least 1 of the following:

Serum M-protein ≥ 0.5 g/dL (> 5 g/L) by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative serum IgA levels; or
Urinary M-protein excretion at least 200 mg/24 hours; or
Serum free light chain (FLC) ≥ 100 mg/L, provided that the serum FLC ratio is abnormal.
Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 anti-MM regimen.
Documented evidence of progressive MM (based on the Investigator's determination according to the modified IMWG response criteria) on or after their most recent regimen.

Prior treatment with bortezomib or other Proteasome Inhibitor (PI) is allowed, provided all of the following criteria are met:

Best response achieved with prior bortezomib at any time was ≥ PR and with the last PI (PI therapy (alone or in combination) was ≥ PR, AND
Participant did not discontinue bortezomib due to ≥ Grade 3 related toxicity, AND
Must have had at least a 6-month PI-treatment-free interval prior to Cycle 1 Day 1 (C1D1) of study treatment.
Must have an ECOG Status score of 0, 1, or 2.
Written informed consent in accordance with federal, local, and institutional guidelines.
Age ≥18 years.
Resolution of any clinically significant non-hematological toxicities (if any) from previous treatments to ≤ Grade 1 by C1D1.
Adequate hepatic function within 28 days prior to C1D1.
Adequate renal function within 28 days prior to C1D1.
Adequate hematopoietic function within 7 days prior to C1D1.
Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

Exclusion Criteria:

Prior exposure to a SINE compound (i.e. an XPO-1 inhibitor), including selinexor.
Prior malignancy that required treatment, or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to randomization.
Any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1.
Active plasma cell leukemia.
Documented systemic light chain amyloidosis.
MM involving the central nervous system.
Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome.
Spinal cord compression.
Greater than Grade 2 neuropathy or ≥ Grade 2 neuropathy with pain at baseline, regardless of whether or not the patient is currently receiving medication
Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy (including investigational therapies) ≤ 2 weeks prior to C1D1. Localized radiation to a single site at least 1 week before C1D1 is permitted. Glucocorticoids within 2 weeks of C1D1 are permitted. Patients on long-term glucocorticoids during Screening do not require a washout period but must be able to tolerate the specified dexamethasone dose in this study.
Prior autologous stem cell transplantation < 1 month or allogeneic stem cell transplantation < 4 months prior to C1D1.
Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.
Pregnant or breastfeeding females.
Body Surface Area < 1.4 m² at baseline, calculated by the Dubois or Mosteller method.
Life expectancy of < 4 months.
Major surgery within 4 weeks prior to C1D1.

Active, unstable cardiovascular function:

Symptomatic ischemia, or
Uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with first-degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded), or
Congestive heart failure of New York Heart Association Class ≥ 3 or known left ventricular ejection fraction < 40%, or
Myocardial infarction within 3 months prior to C1D1.
Known active human immunodeficiency virus (HIV) infection or HIV seropositivity
Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus ribonucleic acid (RNA) or hepatitis B virus surface antigen.
Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
Contraindication to any of the required concomitant drugs or supportive treatments.
Patients unwilling or unable to comply with the protocol, including providing 24-hour urine samples for urine protein electrophoresis at the required time points.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

402

Study ID:

NCT03110562

Recruitment Status:

Active, not recruiting

Sponsor:

Karyopharm Therapeutics Inc

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There are 146 Locations for this study

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Boca Raton Clinical Research (BRCR) Medical Center
Plantation Florida, 33324, United States
Emory University
Atlanta Georgia, 30322, United States
Kaiser Permanente Hawaii
Honolulu Hawaii, 96817, United States
McFarland Clinic
Ames Iowa, 50010, United States
Stormont Vail Health Care (Cotton O'Neil Cancer Center )
Topeka Kansas, 66606, United States
Commonwealth Hematology
Danville Kentucky, 40422, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
University of Maryland
Baltimore Maryland, 21201, United States
Central Care Cancer Center
Bolivar Missouri, 65613, United States
The Valley Hospital Luckow Pavilion
Paramus New Jersey, 07652, United States
Mount Sinai
New York New York, 10029, United States
The Cancer Institute at St. Francis Hospital
Roslyn New York, 11576, United States
Novant-Forsyth Memorial Hospital
Winston-Salem North Carolina, 27103, United States
University of Cincinnati Health
Cincinnati Ohio, 45267, United States
Southwest Cancer Center of Oklahoma
Lawton Oklahoma, 73505, United States
Kaiser Permanente Northwest OR
Portland Oregon, 97210, United States
SCOR AnMed Health Cancer Center
Anderson South Carolina, 29621, United States
Prairie Lakes Healthcare
Watertown South Dakota, 57201, United States
Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
University of Texas Southwestern
Dallas Texas, 75390, United States
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Royal Brisbane and Women's Hospital
Herston Queensland, 4029, Australia
Mater Misericordiae Limited and Mater Medical Research
South Brisbane Queensland, 4101, Australia
Gold Coast University Hospital
Southport Queensland, 4215, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
St. Vincent's Hospital Melbourne
Fitzroy Victoria, 3065, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
Innsbruck , , Austria
University Hospital Krems, Department of Internal Medicine II
Krems , , Austria
Medical University of Vienna
Vienna , 1090, Austria
General Hospital Hietzing
Vienna , 1130, Austria
Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology
Vienna , 1160, Austria
Jules Bordet Institute
Brussels , 1000, Belgium
UCL Saint-Luc
Brussels , , Belgium
University Hospital Ghent
Ghent , 9000, Belgium
General Hospital Delta
Roeselare , 8800, Belgium
St. Augustinus Hospital
Wilrijk , 2610, Belgium
University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology
Plovdiv , 4002, Bulgaria
University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology
Sofia , 1431, Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology
Sofia , 1756, Bulgaria
Tom Baker Cancer Center/ Alberta Health Services
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute / University of Alberta
Edmonton Alberta, T6G 1, Canada
Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
Queen Elizabeth II Health Sciences Center
Halifax Nova Scotia, B3H 2, Canada
North East Cancer Centre Sudbury
Sudbury Ontario, P3E 5, Canada
Princess Margaret Cancer Research
Toronto Ontario, M5G 1, Canada
Maisonneuve-Rosemont Hospital
Montreal Quebec, H1T 2, Canada
Royal Victoria Hospital / McGill University
Montreal Quebec, H3A 1, Canada
L'Hôtel-Dieu de Québec
Quebec City Quebec, G1R 2, Canada
Saskatchewan Cancer Agency-Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada
Saskatoon Cancer Center
Saskatoon Saskatchewan, S7N 4, Canada
General University Hospital in Prague
Praha 2 Prague, 128 0, Czechia
University Hopsital Brno
Brno , 625 0, Czechia
University Hospital Hradec Kralove
Hradec Kralove , 500 0, Czechia
University Hospital Olomouc
Olomouc , 775 2, Czechia
University Hospital Ostrava, Dept. of Hematooncology
Ostrava , 708 5, Czechia
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
Prague , 100 3, Czechia
Necker Children's Hospital, Department of Adult Hematology
Paris Ile De France, 75015, France
Hospital Center Departmental La Roche-Sur-Yon
La Roche-sur-Yon , 85925, France
Claude Huriez Hospital
Lille , 59037, France
South Lyon Hospital Center
Lyon , 69002, France
Brabois Adults Hospital, University Hospital Center of Nancy
Nancy , 54511, France
Nantes University Hospital Center
Nantes , 44093, France
Saint-Louis Hospital
Paris , 75475, France
Miletrie Hospital, University Hospital Center of Poitiers
Poitiers , 86021, France
University Hospital Freiburg, Department of Internal Medicine I
Freiburg Baden-Wuerttemberg, D-791, Germany
Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3
Leverkusen North Rhine Westfalia, 51375, Germany
Group Practice for Hematology and Oncology
Dresden Saxony, 1307, Germany
Alexandra General Hospital, Therapeutic Clinic
Athens , 11528, Greece
General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma
Athens , , Greece
University General Hospital of Patra
Pátra , , Greece
Theageneion Cancer Hospital, Hematology Department
Thessaloníki , 54639, Greece
Semmelweis University, 1st Department of Internal Medicine
Budapest , H-108, Hungary
Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation
Budapest , H-109, Hungary
Semmelweis University, 3rd Department of Internal Medicine
Budapest , H-112, Hungary
Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine
Kaposvar , 7400, Hungary
Medical Center of the University of Pecs, Department of Hematology
Pecs , 7624, Hungary
Regional Cancer Centre
Patna Bihar, 80001, India
Regional Cancer Centre
Thiruvananthapuram Kerala, 69501, India
Prince Aly Khan Hospital
Mumbai Maharashta, 40001, India
Jaslok Hospital and Research Centre
Mumbai Maharashta, 40002, India
Bhaktivedanta Hospital
Thane Maharashtra, 40110, India
IMS & SUM Hospital
Bhubaneswar Odisha, 75100, India
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh Punjab, 16001, India
Dayanand Medical College & Hospital
Ludhiana Punjab, 14100, India
Cancer Institute
Chennai Tamil Nadu, 60002, India
SRM Institute of Medical Sciences
Chennai Tamil Nadu, 60002, India
Saveetha Medical College Hospital
Chennai Tamil Nadu, 60210, India
G. Kuppuswamy Naidu Hospital
Coimbatore Tamil Nadu, 64103, India
Asviratham Speciality Hospital
Madurai Tamil Nadu, 62502, India
Meenakshi Mission Hospital
Madurai Tamil Nadu, 62510, India
Yashoda Hospital
Hyderabad Telengana, 50008, India
King George's Medical University
Lucknow Uttar Pradesh, 22600, India
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata West Bengal, 70009, India
Nil Ratan Sircar (NRS) Medical College
Kolkata West Bengal, 70012, India
TATA Memorial Centre
Kolkata West Bengal, 70016, India
Rajiv Gandhi Cancer Hospital
New Delhi , 11008, India
Barzilai Medical Center
Ashkelon , 78306, Israel
Rambam Health Care Campus
Haifa , 31096, Israel
Hadassah Medical Center
Jerusalem , , Israel
Rabin Medical Center
Petaẖ Tiqwa , 49100, Israel
Hospital Santa Maria of Terni
Terni Umbria, 05100, Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ancona , 60131, Italy
ASST Papa Giovanni XXIII
Bergamo , 24127, Italy
Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo
Bologna , 40138, Italy
University Hospital Careggi, Department of Hematology
Florence , 50134, Italy
University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology
Genoa , 16132, Italy
Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit
Milan , 20162, Italy
Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center
Rome , 00161, Italy
University Hospital San Giovanni Battista of Turin
Turin , 10126, Italy
Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology
Bydgoszcz , 85-16, Poland
Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology
Chorzow , 41-50, Poland
University Hospital in Krakow, Teaching Unit of the Hematology Department
Krakow , 31-50, Poland
Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation
Lublin , 20-08, Poland
St. John of Dukla Oncology Center of Lublin, Department of Hematology
Lublin , 20-09, Poland
Military Institute of Medicine, Department of Internal Medicine and Hematology
Warsaw , 04-14, Poland
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology
Łódź , 93-51, Poland
Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department
BraÅŸov , 50036, Romania
Colentina Clinical Hospital, Department of Hematology
Bucharest , 02012, Romania
Bucharest University Emergency Hospital, Department of Hematology
Bucharest , 05009, Romania
S.P. Botkin City Clinical Hospital
Moscow , 12528, Russian Federation
N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways
Moscow , 12912, Russian Federation
First I.P. Pavlov State Medical University of St. Petersburg
Saint Petersburg , 19702, Russian Federation
V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1
Saint Petersburg , 19734, Russian Federation
Clinical Center of Serbia, Clinic of Hematology
Belgrade , 11000, Serbia
Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology
Belgrade , 11000, Serbia
Clinical Center Kragujevac, Clinic of Hematology
Kragujevac , 34 00, Serbia
Clinical Center Nis, Clinic of Hematology and Clinical Immunology
Nis , 18 00, Serbia
Clinical Center of Vojvodina, Clinic of Hematology
Novi Sad , 21 00, Serbia
University Hospital of the Canary Islands
La Laguna Santa Cruz De Tenerife, 38320, Spain
Catalan Institute of Oncology (ICO) Badalona
Badalona , 08916, Spain
University Hospital of Vall d'Hebron
Barcelona , 08035, Spain
University Hospital Infanta Leonor, Department of Hematology
Madrid , 28301, Spain
University Clinical Hospital of Salamanca, Department of Hematology
Salamanca , 37007, Spain
University Hospital Virgen del Rocio (HUVR)
Seville , 41013, Spain
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
Cherkasy , 18009, Ukraine
City Clinical Hospital No.4 of Dnipro City Council, City hematology center
Dnipropetrovsk , , Ukraine
BMT Kiev Center
Kiev , , Ukraine
Kiev Cancer Institute
Kiev , , Ukraine
Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group
Lviv , 79044, Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology
Vinnytsia , 21018, Ukraine
O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards
Zhytomyr , 10008, Ukraine
Belfast Heatlh & Social Care Trust Belfast City Hospital
Belfast Northern Ireland, BT9 7, United Kingdom
NHS Tayside Ninewells Hospital
Dundee Scotland, DD1 9, United Kingdom
Cardiff & Vale University Health Board University Hospital of Wales
Cardiff Wales, CF14 , United Kingdom
University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
Birmingham , B15 2, United Kingdom
The Leeds Teaching Hospitals NHS Trust St. James University Hospital
Leeds , LS9 7, United Kingdom
University Hospitals of Leicester NHS Trust Royal Leicester Infirmary
Leicester , LE1 5, United Kingdom
Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital
Liverpool , L7 8X, United Kingdom
London North West Healthcare NHS Trust Northwick Park Hospital
London , HA1 3, United Kingdom
University College London
London , NW3 2, United Kingdom
King's College Hospital NHS Foundation Trust
London , SE5 9, United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital
London , W12 0, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Freeman Hospital
Newcastle Upon Tyne , NE7 7, United Kingdom
The Royal Wolverhampton NHS Trust New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

402

Study ID:

NCT03110562

Recruitment Status:

Active, not recruiting

Sponsor:


Karyopharm Therapeutics Inc

How clear is this clinincal trial information?

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