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Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma (BOSTON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03110562
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Selinexor Drug: Bortezomib Drug: Dexamethasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Active Comparator: selinexor+bortezomib+dexamethasone (SVd)
Selinexor will be given on Days 1, 8, 15, 22, and 29 of each 35-day cycle. Bortezomib will be given Days 1, 8, 15, and 22 of each 35-day cycle. Dexamethasone will be given Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle.
Drug: Selinexor
oral 100 mg dose

Drug: Bortezomib
subcutaneous dose of 1.3 mg/m2
Other Name: Velcade®

Drug: Dexamethasone
oral dose of 20mg

Active Comparator: bortezomib+dexamethasone (Vd)
Bortezomib will be given Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles. For Cycles ≥ 9, bortezomib will be given on Days 1, 8, 15, and 22 of each 35-day cycle. Dexamethasone will be given on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles. For Cycles ≥ 9, dexamethasone will be given on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle.
Drug: Bortezomib
subcutaneous dose of 1.3 mg/m2
Other Name: Velcade®

Drug: Dexamethasone
oral dose of 20mg




Primary Outcome Measures :
  1. Compare progression-free survival (PFS) based on the Independent Review Committee's (IRC's) disease outcome assessments in patients randomized to the SVd Arm versus the Vd Arm [ Time Frame: 15 months ]
    PFS, defined as time from date of randomization until the first date of PD, per International Myeloma Working Group (IMWG) response criteria, or death due to any cause, whichever occurs first. For the purposes of PFS determination, PD will be determined by the IRC.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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:

    • 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.
  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.
  9. Adequate hepatic function within 28 days prior to C1D1.
  10. Adequate renal function within 28 days prior to C1D1.
  11. Adequate hematopoietic function within 7 days prior to C1D1.
  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.
  3. 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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110562


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Locations
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United States, Florida
Boca Raton Clinical Research (BRCR) Medical Center
Plantation, Florida, United States, 33324
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96817
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
United States, Kansas
Stormont Vail Health Care (Cotton O'Neil Cancer Center )
Topeka, Kansas, United States, 66606
United States, Kentucky
Commonwealth Hematology
Danville, Kentucky, United States, 40422
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Missouri
Central Care Cancer Center
Bolivar, Missouri, United States, 65613
United States, New Jersey
The Valley Hospital Luckow Pavilion
Paramus, New Jersey, United States, 07652
United States, New York
Mount Sinai
New York, New York, United States, 10029
The Cancer Institute at St. Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Novant-Forsyth Memorial Hospital
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University of Cincinnati Health
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
Southwest Cancer Center of Oklahoma
Lawton, Oklahoma, United States, 73505
United States, Oregon
Kaiser Permanente Northwest OR
Portland, Oregon, United States, 97210
United States, South Carolina
SCOR AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
United States, South Dakota
Prairie Lakes Healthcare
Watertown, South Dakota, United States, 57201
United States, Texas
Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
University of Texas Southwestern
Dallas, Texas, United States, 75390
Australia, New South Wales
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Misericordiae Limited and Mater Medical Research
South Brisbane, Queensland, Australia, 4101
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Austria
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, 1090
General Hospital Hietzing
Vienna, Austria, 1130
Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology
Vienna, Austria, 1160
Belgium
Jules Bordet Institute
Brussels, Belgium, 1000
UCL Saint-Luc
Brussels, Belgium
University Hospital Ghent
Ghent, Belgium, 9000
General Hospital Delta
Roeselare, Belgium, 8800
St. Augustinus Hospital
Wilrijk, Belgium, 2610
Bulgaria
University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology
Plovdiv, Bulgaria, 4002
University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology
Sofia, Bulgaria, 1431
Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology
Sofia, Bulgaria, 1756
Canada, Alberta
Tom Baker Cancer Center/ Alberta Health Services
Calgary, Alberta, Canada, T2N 4Z6
Cross Cancer Institute / University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
North East Cancer Centre Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Princess Margaret Cancer Research
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Royal Victoria Hospital / McGill University
Montreal, Quebec, Canada, H3A 1A1
L'Hôtel-Dieu de Québec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Saskatchewan Cancer Agency-Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7TI
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada, S7N 4H4
Czechia
General University Hospital in Prague
Praha 2, Prague, Czechia, 128 08
University Hopsital Brno
Brno, Czechia, 625 00
University Hospital Hradec Kralove
Hradec Kralove, Czechia, 500 05
University Hospital Olomouc
Olomouc, Czechia, 775 20
University Hospital Ostrava, Dept. of Hematooncology
Ostrava, Czechia, 708 52
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
Prague, Czechia, 100 34
France
Necker Children's Hospital, Department of Adult Hematology
Paris, Ile De France, France, 75015
Hospital Center Departmental La Roche-Sur-Yon
La Roche-sur-Yon, France, 85925
Claude Huriez Hospital
Lille, France, 59037
South Lyon Hospital Center
Lyon, France, 69002
Brabois Adults Hospital, University Hospital Center of Nancy
Nancy, France, 54511
Nantes University Hospital Center
Nantes, France, 44093
Saint-Louis Hospital
Paris, France, 75475
Miletrie Hospital, University Hospital Center of Poitiers
Poitiers, France, 86021
Germany
University Hospital Freiburg, Department of Internal Medicine I
Freiburg, Baden-Wuerttemberg, Germany, D-79106
Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3
Leverkusen, North Rhine Westfalia, Germany, 51375
Group Practice for Hematology and Oncology
Dresden, Saxony, Germany, 1307
Greece
Alexandra General Hospital, Therapeutic Clinic
Athens, Greece, 11528
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, Greece, 54639
Hungary
Semmelweis University, 1st Department of Internal Medicine
Budapest, Hungary, H-1083
Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation
Budapest, Hungary, H-1097
Semmelweis University, 3rd Department of Internal Medicine
Budapest, Hungary, H-1125
Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine
Kaposvar, Hungary, 7400
Medical Center of the University of Pecs, Department of Hematology
Pecs, Hungary, 7624
India
Regional Cancer Centre
Patna, Bihar, India, 800014
Regional Cancer Centre
Thiruvananthapuram, Kerala, India, 695011
Prince Aly Khan Hospital
Mumbai, Maharashta, India, 400010
Jaslok Hospital and Research Centre
Mumbai, Maharashta, India, 400026
Bhaktivedanta Hospital
Thane, Maharashtra, India, 401107
IMS & SUM Hospital
Bhubaneswar, Odisha, India, 751003
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, Punjab, India, 160012
Dayanand Medical College & Hospital
Ludhiana, Punjab, India, 141001
Cancer Institute
Chennai, Tamil Nadu, India, 600020
SRM Institute of Medical Sciences
Chennai, Tamil Nadu, India, 600026
Saveetha Medical College Hospital
Chennai, Tamil Nadu, India, 602105
G. Kuppuswamy Naidu Hospital
Coimbatore, Tamil Nadu, India, 641037
Asviratham Speciality Hospital
Madurai, Tamil Nadu, India, 625020
Meenakshi Mission Hospital
Madurai, Tamil Nadu, India, 625107
Yashoda Hospital
Hyderabad, Telengana, India, 500082
King George's Medical University
Lucknow, Uttar Pradesh, India, 226003
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, West Bengal, India, 700094
Nil Ratan Sircar (NRS) Medical College
Kolkata, West Bengal, India, 700120
TATA Memorial Centre
Kolkata, West Bengal, India, 700160
Rajiv Gandhi Cancer Hospital
New Delhi, India, 110085
Israel
Barzilai Medical Center
Ashkelon, Israel, 7830604
Rambam Health Care Campus
Haifa, Israel, 3109601
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petaẖ Tiqwa, Israel, 49100
Italy
Hospital Santa Maria of Terni
Terni, Umbria, Italy, 05100
Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ancona, Italy, 60131
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo
Bologna, Italy, 40138
University Hospital Careggi, Department of Hematology
Florence, Italy, 50134
University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology
Genoa, Italy, 16132
Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit
Milan, Italy, 20162
Umberto I Polyclinic of Romw, Department of Cellular Biotechnology and Hematology, Hematology Center
Rome, Italy, 00161
University Hospital San Giovanni Battista of Turin
Turin, Italy, 10126
Poland
Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology
Bydgoszcz, Poland, 85-168
Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology
Chorzow, Poland, 41-500
University Hospital in Krakow, Teaching Unit of the Hematology Department
Krakow, Poland, 31-501
Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation
Lublin, Poland, 20-081
St. John of Dukla Oncology Center of Lublin, Department of Hematology
Lublin, Poland, 20-090
Military Institute of Medicine, Department of Internal Medicine and Hematology
Warsaw, Poland, 04-141
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology
Łódź, Poland, 93-513
Romania
Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department
Braşov, Romania, 500366
Colentina Clinical Hospital, Department of Hematology
Bucharest, Romania, 020125
Bucharest University Emergency Hospital, Department of Hematology
Bucharest, Romania, 050098
Russian Federation
S.P. Botkin City Clinical Hospital
Moscow, Russian Federation, 125284
N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways
Moscow, Russian Federation, 129128
First I.P. Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russian Federation, 197022
V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1
Saint Petersburg, Russian Federation, 197341
Serbia
Clinical Center of Serbia, Clinic of Hematology
Belgrade, Serbia, 11000
Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology
Belgrade, Serbia, 11000
Clinical Center Kragujevac, Clinic of Hematology
Kragujevac, Serbia, 34 000
Clinical Center Nis, Clinic of Hematology and Clinical Immunology
Nis, Serbia, 18 000
Clinical Center of Vojvodina, Clinic of Hematology
Novi Sad, Serbia, 21 000
Spain
University Hospital of the Canary Islands
La Laguna, Santa Cruz De Tenerife, Spain, 38320
Catalan Institute of Oncology (ICO) Badalona
Badalona, Spain, 08916
University Hospital of Vall d'Hebron
Barcelona, Spain, 08035
University Hospital Infanta Leonor, Department of Hematology
Madrid, Spain, 28301
University Clinical Hospital of Salamanca, Department of Hematology
Salamanca, Spain, 37007
University Hospital Virgen del Rocio (HUVR)
Seville, Spain, 41013
Ukraine
Cherkasy Rgional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
Cherkasy, Ukraine, 18009
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Regional 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, 79044
Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology
Vinnytsia, Ukraine, 21018
O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards
Zhytomyr, Ukraine, 10008
United Kingdom
Belfast Heatlh & Social Care Trust Belfast City Hospital
Belfast, Northern Ireland, United Kingdom, BT9 7AB
NHS Tayside Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Cardiff & Vale University Health Board University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
The Leeds Teaching Hospitals NHS Trust St. James University Hospital
Leeds, United Kingdom, LS9 7TF
University Hospitals of Leicester NHS Trust Royal Leicester Infirmary
Leicester, United Kingdom, LE1 5WW
Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
London North West Healthcare NHS Trust Northwick Park Hospital
London, United Kingdom, HA1 3UJ
University College London
London, United Kingdom, NW3 2PF
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Imperial College Healthcare NHS Trust Hammersmith Hospital
London, United Kingdom, W12 0HS
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Freeman Hospital
Newcastle Upon Tyne, United Kingdom, NE7 7DN
The Royal Wolverhampton NHS Trust New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
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Study Director: Michael Kauffman, MD, PhD Karyopharm Therapeutics Inc

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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT03110562     History of Changes
Other Study ID Numbers: KCP-330-023
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karyopharm Therapeutics Inc:
Relapsed or Refractory Multiple Myeloma
RRMM
Bortezomib
Dexamethasone
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors