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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | Experimental | Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. |
|
| Vd Arm: Bortezomib + Dexamethasone | Experimental | Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by greater than or equal to (>=) 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. |
|
| SVdX Arm: Selinexor + Bortezomib + Dexamethasone | Experimental | Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor | Drug | oral 100 mg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Histologically confirmed MM with measurable disease per IMWG guidelines as defined by at least 1 of the following:
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:
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.
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:
However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study.
12. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
Exclusion Criteria:
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.
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:
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boca Raton Clinical Research (BRCR) Medical Center | Plantation | Florida | 33324 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37743180 | Derived | 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. | |
| 37393120 | Derived | 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. |
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Following confirmation of progressive disease (PD) by the Independent Review Committee (IRC), 204 participants in the safety population who received Vd treatment were allowed to cross over to receive either SVdX treatment (66 participants) or SdX treatment (14 participants).
The study was conducted at 165 investigative sites in 21 countries. A total of 402 participants were enrolled and randomized, of which 399 participants received SVd treatment (195 participants) or Vd treatment (204 participants).
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| ID | Title | Description |
|---|---|---|
| FG000 | SVd Arm: Selinexor + Bortezomib + Dexamethasone | Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 17, 2018 | Jun 14, 2021 |
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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.
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|
| SdX Arm: Selinexor + Dexamethasone | Experimental | Participants in the VD arm who had IRC-confirmed PD and were unable to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. |
|
| Bortezomib | Drug | subcutaneous dose of 1.3 mg/m2 |
|
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| Dexamethasone | Drug | oral dose of 20mg |
|
| From date of randomization until disease progression or initiating a new MM treatment (up to 33 months) |
| 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. | From date of randomization until confirmed PD or initiating a new MM treatment (up to 33 months) |
| 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. | 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) |
| 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. | From date of randomization to the date of death or censored date, whichever occurred first (up to 45 months) |
| 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. | From the first documentation of response to the first documentation of PD or death, whichever occurred first (up to 45 months) |
| 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. | From date of first SVdX treatment until disease progression or initiating a new MM treatment (up to 33 months) |
| 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%). | From date of first SVdX treatment until IRC-confirmed documented PD or death or censored date, whichever occurred first (up to 33 months) |
| 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. | From date of randomization to start of next anti-MM treatment or death, whichever occurred first (up to 33 months) |
| 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. | 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) |
| 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%). | 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) |
| 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. | Svd Arm: Baseline up to End of treatment (EOT) (at Day 820); Vd Arm: Baseline up to EOT (at Day 848) |
| 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 4Z6 | Canada |
| Cross Cancer Institute / University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| North East Cancer Centre Sudbury | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Princess Margaret Cancer Research | Toronto | Ontario | M5G 1X5 | Canada |
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | H1T 2M4 | Canada |
| Royal Victoria Hospital / McGill University | Montreal | Quebec | H3A 1A1 | Canada |
| L'Hôtel-Dieu de Québec | Québec | Quebec | G1R 2J6 | Canada |
| Saskatchewan Cancer Agency-Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7TI | Canada |
| Saskatoon Cancer Center | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| General University Hospital in Prague | Prague | Prague | 128 08 | Czechia |
| University Hopsital Brno | Brno | 625 00 | Czechia |
| University Hospital Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| University Hospital Olomouc | Olomouc | 775 20 | Czechia |
| University Hospital Ostrava, Dept. of Hematooncology | Ostrava | 708 52 | Czechia |
| University Hospital Kralovske Vinohrady, Clinic of Internal Hematology | Prague | 100 34 | Czechia |
| 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 |
| Necker Children's Hospital, Department of Adult Hematology | Paris | Île-de-France Region | 75015 | France |
| University Hospital Freiburg, Department of Internal Medicine I | Freiburg im Breisgau | Baden-Wurttemberg | D-79106 | 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 | Pátrai | Greece |
| Theageneion Cancer Hospital, Hematology Department | Thessaloniki | 54639 | Greece |
| Semmelweis University, 1st Department of Internal Medicine | Budapest | H-1083 | Hungary |
| Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation | Budapest | H-1097 | Hungary |
| Semmelweis University, 3rd Department of Internal Medicine | Budapest | H-1125 | Hungary |
| Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine | Kaposvár | 7400 | Hungary |
| Medical Center of the University of Pecs, Department of Hematology | Pécs | 7624 | Hungary |
| Regional Cancer Centre | Patna | Bihar | 800014 | India |
| Regional Cancer Centre | Thiruvananthapuram | Kerala | 695011 | India |
| Prince Aly Khan Hospital | Mumbai | Maharashta | 400010 | India |
| Jaslok Hospital and Research Centre | Mumbai | Maharashta | 400026 | India |
| Bhaktivedanta Hospital | Thane | Maharashtra | 401107 | India |
| IMS & SUM Hospital | Bhubaneswar | Odisha | 751003 | India |
| Postgraduate Institute of Medical Education & Research (PGIMER) | Chandigarh | Punjab | 160012 | India |
| Dayanand Medical College & Hospital | Ludhiana | Punjab | 141001 | India |
| Cancer Institute | Chennai | Tamil Nadu | 600020 | India |
| SRM Institute of Medical Sciences | Chennai | Tamil Nadu | 600026 | India |
| Saveetha Medical College Hospital | Chennai | Tamil Nadu | 602105 | India |
| G. Kuppuswamy Naidu Hospital | Coimbatore | Tamil Nadu | 641037 | India |
| Asviratham Speciality Hospital | Madurai | Tamil Nadu | 625020 | India |
| Meenakshi Mission Hospital | Madurai | Tamil Nadu | 625107 | India |
| Yashoda Hospital | Hyderabad | Telangana | 500082 | India |
| King George's Medical University | Lucknow | Uttar Pradesh | 226003 | India |
| Netaji Subhash Chandra Bose Cancer Research Institute | Kolkata | West Bengal | 700094 | India |
| Nil Ratan Sircar (NRS) Medical College | Kolkata | West Bengal | 700120 | India |
| TATA Memorial Centre | Kolkata | West Bengal | 700160 | India |
| Rajiv Gandhi Cancer Hospital | New Delhi | 110085 | India |
| Barzilai Medical Center | Ashkelon | 7830604 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Hadassah Medical Center | Jerusalem | Israel |
| Rabin Medical Center | Petah Tikva | 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 | 85-168 | Poland |
| Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology | Chorzów | 41-500 | Poland |
| University Hospital in Krakow, Teaching Unit of the Hematology Department | Krakow | 31-501 | Poland |
| Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology | Lodz | 93-513 | Poland |
| Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation | Lublin | 20-081 | Poland |
| St. John of Dukla Oncology Center of Lublin, Department of Hematology | Lublin | 20-090 | Poland |
| Military Institute of Medicine, Department of Internal Medicine and Hematology | Warsaw | 04-141 | Poland |
| Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department | Brasov | 500366 | Romania |
| Colentina Clinical Hospital, Department of Hematology | Bucharest | 020125 | Romania |
| Bucharest University Emergency Hospital, Department of Hematology | Bucharest | 050098 | Romania |
| S.P. Botkin City Clinical Hospital | Moscow | 125284 | Russia |
| N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways | Moscow | 129128 | Russia |
| First I.P. Pavlov State Medical University of St. Petersburg | Saint Petersburg | 197022 | Russia |
| V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1 | Saint Petersburg | 197341 | Russia |
| 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 | 34 000 | Serbia |
| Clinical Center Nis, Clinic of Hematology and Clinical Immunology | Niš | 18 000 | Serbia |
| Clinical Center of Vojvodina, Clinic of Hematology | Novi Sad | 21 000 | Serbia |
| University Hospital of the Canary Islands | San Cristóbal de 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 7AB | United Kingdom |
| NHS Tayside Ninewells Hospital | Dundee | Scotland | DD1 9SY | United Kingdom |
| Cardiff & Vale University Health Board University Hospital of Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| The Leeds Teaching Hospitals NHS Trust St. James University Hospital | Leeds | LS9 7TF | United Kingdom |
| University Hospitals of Leicester NHS Trust Royal Leicester Infirmary | Leicester | LE1 5WW | United Kingdom |
| Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| London North West Healthcare NHS Trust Northwick Park Hospital | London | HA1 3UJ | United Kingdom |
| University College London | London | NW3 2PF | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| Imperial College Healthcare NHS Trust Hammersmith Hospital | London | W12 0HS | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| The Royal Wolverhampton NHS Trust New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| 34882831 | Derived | 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. |
| 34062004 | Derived | 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. |
| 33849608 | Derived | 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. |
| 33755235 | Derived | 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. |
| 33189178 | Derived | 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. |
| FG001 | Vd Arm: Bortezomib + Dexamethasone | Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by greater than or equal to (>=) 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles >= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. |
| FG002 | SVdX Arm: Selinexor + Bortezomib + Dexamethasone | Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. |
| FG003 | SdX Arm: Selinexor + Dexamethasone | Participants in the VD arm who had IRC-confirmed PD and were unable to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. |
| Treated |
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| Intent-to-treat (ITT) Population | The ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. |
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| Safety Population | The safety population consisted of all participants who had received at least 1 dose of the study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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| Crossover Period |
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Intent-to-treat (ITT) population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SVd Arm: Selinexor + Bortezomib + Dexamethasone | Participants received a 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. |
| BG001 | Vd Arm: Bortezomib + Dexamethasone | Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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%). | ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months) |
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| Secondary | 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. | ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization until disease progression or initiating a new MM treatment (up to 33 months) |
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| Secondary | 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. | ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization until confirmed PD or initiating a new MM treatment (up to 33 months) |
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| Secondary | 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. | Safety population included of all participants who had received at least 1 dose of the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm. | Posted | Median | 95% Confidence Interval | Months | From date of randomization to the date of death or censored date, whichever occurred first (up to 45 months) |
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| Secondary | 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. | ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm. | Posted | Median | 95% Confidence Interval | Months | From the first documentation of response to the first documentation of PD or death, whichever occurred first (up to 45 months) |
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| Secondary | 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. | The SVdX population consisted of a subset of participants in the Vd arm of the safety population who crossed over from the Vd arm to SVdX treatment after IRC confirmation of PD on Vd and had received at least 1 dose of selinexor. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first SVdX treatment until disease progression or initiating a new MM treatment (up to 33 months) |
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| Secondary | 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%). | The SVdX population consisted of a subset of participants in the Vd arm of the safety population who crossed over from the Vd arm to SVdX treatment after IRC confirmation of PD on Vd and had received at least 1 dose of selinexor. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From date of first SVdX treatment until IRC-confirmed documented PD or death or censored date, whichever occurred first (up to 33 months) |
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| Secondary | 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. | The ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm. | Posted | Median | 95% Confidence Interval | Months | From date of randomization to start of next anti-MM treatment or death, whichever occurred first (up to 33 months) |
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| Secondary | 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. | The ITT population consisted of all patients who were randomized to the study treatment, regardless of whether or not they received the study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Data was not planned to be reported for SVdx arm and Sdx arm. | Posted | Median | 95% Confidence Interval | Months | 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) |
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| Secondary | 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%). | The ITT population consisted of all patients who were randomized to the study treatment, regardless of whether or not they received the study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Data was not planned to be reported for Sdx arm. | Posted | Median | 95% Confidence Interval | Months | 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) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population consisted of all patients who were randomized to the study treatment, regardless of whether or not they received the study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Data was not planned to be reported for SVdx arm and Sdx arm. | Posted | Mean | Standard Deviation | Score on a Scale | Svd Arm: Baseline up to End of treatment (EOT) (at Day 820); Vd Arm: Baseline up to EOT (at Day 848) |
|
From date of randomization up to 45 months
In other adverse events section, System Organ Classes for SVD and VD arms were recorded as per MedDRA version 24.1 and remaining events were recorded as per MedDRA version 22.0.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SVd Arm: Selinexor + Bortezomib + Dexamethasone | Participants received a 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. | 74 | 195 | 109 | 195 | 193 | 195 |
| EG001 | Vd Arm: Bortezomib + Dexamethasone | Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 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. | 82 | 204 | 79 | 204 | 197 | 204 |
| EG002 | SVdX Arm: Selinexor + Bortezomib + Dexamethasone | Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. | 37 | 66 | 28 | 66 | 65 | 66 |
| EG003 | SdX Arm: Selinexor + Dexamethasone | Participants in the VD arm who had IRC-confirmed PD and were unable to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, 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. | 3 | 14 | 7 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Meningitis tuberculous | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Carotid artery aneurysm | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vascular dementia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Mixed anxiety and depressive disorder | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Reactive psychosis | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood pressure fluctuation | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karyopharm Medical Information | Karyopharm Therapeutics Inc. | (888) 209-9326 | clinicaltrials@karyopharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2020 | Jun 14, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C585161 | selinexor |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Withdrawal by Subject |
|
| Death |
|
| Lost to Follow-up |
|
| Other |
|
| Participants withdrawn due to company goals |
|
| Male |
|
| Black or African American |
|
| White |
|
| Other |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
| Unknown |
|
| Missing |
|
| OG001 | Vd Arm: Bortezomib + Dexamethasone | Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 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. |
|
|
|
| OG001 |
| Vd Arm: Bortezomib + Dexamethasone |
Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 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. |
|
|
|
| OG001 | Vd Arm: Bortezomib + Dexamethasone | Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 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. |
|
|
|
|
|
|
| OG001 | Vd Arm: Bortezomib + Dexamethasone | Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 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. |
|
|
|
|
|
|
| OG001 |
| Vd Arm: Bortezomib + Dexamethasone |
Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 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. |
|
|
| OG001 | Vd Arm: Bortezomib + Dexamethasone | Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 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. |
|
|
Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
| OG001 | Vd Arm (Non-Crossover): Bortezomib + Dexamethasone | Participants who did not cross over were included and 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 >= 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. |
| OG002 | SVdX Arm: Selinexor + Bortezomib + Dexamethasone | Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study. |
|
|
| OG001 | Vd Arm: Bortezomib + Dexamethasone | Participants received SC injection of 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by >= 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. |
|
|