Multiple Myeloma Clinical Trial
Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
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.
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.
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.
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There are 146 Locations for this study
Plantation Florida, 33324, United States
Atlanta Georgia, 30322, United States
Honolulu Hawaii, 96817, United States
Ames Iowa, 50010, United States
Topeka Kansas, 66606, United States
Danville Kentucky, 40422, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21201, United States
Bolivar Missouri, 65613, United States
Paramus New Jersey, 07652, United States
New York New York, 10029, United States
Roslyn New York, 11576, United States
Winston-Salem North Carolina, 27103, United States
Cincinnati Ohio, 45267, United States
Lawton Oklahoma, 73505, United States
Portland Oregon, 97210, United States
Anderson South Carolina, 29621, United States
Watertown South Dakota, 57201, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
Waratah New South Wales, 2298, Australia
Herston Queensland, 4029, Australia
South Brisbane Queensland, 4101, Australia
Southport Queensland, 4215, Australia
Adelaide South Australia, 5000, Australia
Bedford Park South Australia, 5042, Australia
Fitzroy Victoria, 3065, Australia
Melbourne Victoria, 3004, Australia
Innsbruck , , Austria
Krems , , Austria
Vienna , 1090, Austria
Vienna , 1130, Austria
Vienna , 1160, Austria
Brussels , 1000, Belgium
Brussels , , Belgium
Ghent , 9000, Belgium
Roeselare , 8800, Belgium
Wilrijk , 2610, Belgium
Plovdiv , 4002, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1756, Bulgaria
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 1, Canada
Halifax Nova Scotia, B3H 2, Canada
Sudbury Ontario, P3E 5, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H3A 1, Canada
Quebec City Quebec, G1R 2, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Praha 2 Prague, 128 0, Czechia
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 775 2, Czechia
Ostrava , 708 5, Czechia
Prague , 100 3, Czechia
Paris Ile De France, 75015, France
La Roche-sur-Yon , 85925, France
Lille , 59037, France
Lyon , 69002, France
Nancy , 54511, France
Nantes , 44093, France
Paris , 75475, France
Poitiers , 86021, France
Freiburg Baden-Wuerttemberg, D-791, Germany
Leverkusen North Rhine Westfalia, 51375, Germany
Dresden Saxony, 1307, Germany
Athens , 11528, Greece
Athens , , Greece
Pátra , , Greece
Thessaloníki , 54639, Greece
Budapest , H-108, Hungary
Budapest , H-109, Hungary
Budapest , H-112, Hungary
Kaposvar , 7400, Hungary
Pecs , 7624, Hungary
Patna Bihar, 80001, India
Thiruvananthapuram Kerala, 69501, India
Mumbai Maharashta, 40001, India
Mumbai Maharashta, 40002, India
Thane Maharashtra, 40110, India
Bhubaneswar Odisha, 75100, India
Chandigarh Punjab, 16001, India
Ludhiana Punjab, 14100, India
Chennai Tamil Nadu, 60002, India
Chennai Tamil Nadu, 60002, India
Chennai Tamil Nadu, 60210, India
Coimbatore Tamil Nadu, 64103, India
Madurai Tamil Nadu, 62502, India
Madurai Tamil Nadu, 62510, India
Hyderabad Telengana, 50008, India
Lucknow Uttar Pradesh, 22600, India
Kolkata West Bengal, 70009, India
Kolkata West Bengal, 70012, India
Kolkata West Bengal, 70016, India
New Delhi , 11008, India
Ashkelon , 78306, Israel
Haifa , 31096, Israel
Jerusalem , , Israel
Petaẖ Tiqwa , 49100, Israel
Terni Umbria, 05100, Italy
Ancona , 60131, Italy
Bergamo , 24127, Italy
Bologna , 40138, Italy
Florence , 50134, Italy
Genoa , 16132, Italy
Milan , 20162, Italy
Rome , 00161, Italy
Turin , 10126, Italy
Bydgoszcz , 85-16, Poland
Chorzow , 41-50, Poland
Krakow , 31-50, Poland
Lublin , 20-08, Poland
Lublin , 20-09, Poland
Warsaw , 04-14, Poland
Łódź , 93-51, Poland
Braşov , 50036, Romania
Bucharest , 02012, Romania
Bucharest , 05009, Romania
Moscow , 12528, Russian Federation
Moscow , 12912, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint Petersburg , 19734, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Kragujevac , 34 00, Serbia
Nis , 18 00, Serbia
Novi Sad , 21 00, Serbia
La Laguna Santa Cruz De Tenerife, 38320, Spain
Badalona , 08916, Spain
Barcelona , 08035, Spain
Madrid , 28301, Spain
Salamanca , 37007, Spain
Seville , 41013, Spain
Cherkasy , 18009, Ukraine
Dnipropetrovsk , , Ukraine
Kiev , , Ukraine
Kiev , , Ukraine
Lviv , 79044, Ukraine
Vinnytsia , 21018, Ukraine
Zhytomyr , 10008, Ukraine
Belfast Northern Ireland, BT9 7, United Kingdom
Dundee Scotland, DD1 9, United Kingdom
Cardiff Wales, CF14 , United Kingdom
Birmingham , B15 2, United Kingdom
Leeds , LS9 7, United Kingdom
Leicester , LE1 5, United Kingdom
Liverpool , L7 8X, United Kingdom
London , HA1 3, United Kingdom
London , NW3 2, United Kingdom
London , SE5 9, United Kingdom
London , W12 0, United Kingdom
Manchester , M20 4, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
Wolverhampton , WV10 , United Kingdom
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