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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03170882
Other study ID # C16029
Secondary ID 2016-004742-28U1
Status Completed
Phase Phase 2
First received
Last updated
Start date August 1, 2017
Est. completion date November 26, 2021

Study information

Verified date November 2022
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance. - Ixazomib capsules, given with dexamethasone tablets - Pomalidomide capsules, given with dexamethasone tablets All participants will take their study medicine on specific days during a 28-day cycle. The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home. After treatment, participants will visit the clinic every 12 weeks for a check-up. If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.


Description:

The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM). This study will compare the efficacy and safety in participants who take ixazomib and dexamethasone to pomalidomide and dexamethasone. It is an open-label, Phase 2 study. The study will enroll approximately 120 participants. Participants will receive: - Ixazomib 4 mg + dexamethasone 20 mg (or 10 mg if participant is aged >=75 years) OR - Pomalidomide 4 mg + dexamethasone 40 mg (or 20 mg if participant is aged >=75 years) All participants will be asked to take either ixazomib plus dexamethasone (in cases where only 4 mg tablets for dexamethasone are available, the following dexamethasone schedule is recommended for participants aged >=75 years: 12 mg dexamethasone will be given on Days 1, 8, 15, and 22 of every 28-day cycle; and 8 mg dexamethasone will be given on Days 2, 9, 16, and 23 of every 28-day cycle) or pomalidomide 4 mg + dexamethasone 40 mg at recommended doses. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 28 months after the first participant enters the study. Participants will make multiple visits to the clinic, and will be contacted for progression free-survival (PFS) follow-up, in case of study drug discontinuation for up to 4 years from first dose administration. After disease progression, participants will be followed-up for overall survival (OS) every 12 weeks until death or up to 4 years. Alternative methods for administering study procedures/assessments may be considered when it is not possible for the participants to come to the study site due to extenuating circumstances (e.g., due to the COVID-19 pandemic).


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date November 26, 2021
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Must have a confirmed diagnosis of multiple myeloma (MM) requiring therapy according to International Myeloma Working Group (IMWG) criteria. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 3. Must have had a relapse or progressive disease (PD) after having received 2 or more prior lines of systemic therapy. Note: A line of therapy is defined as 1 or more cycles of a planned treatment program; this may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. For example, a planned treatment approach of induction therapy followed by autologous stem cell transplantation (SCT), followed by maintenance is considered 1 line of therapy. Typically each line of therapy is separated by PD. Discussion with the medical monitor may help clarify the number of lines of therapy that a prospective study participant had. 4. Must be refractory to lenalidomide, defined as having received at least 2 consecutive cycles of lenalidomide as a single agent or within a lenalidomide-containing regimen and having had PD during treatment with or within 60 days after the last dose of lenalidomide. The starting dose of lenalidomide should have been 25 mg (or as low as 10 mg in the case of renal function impairment or other safety concern), and the final dose should have been a minimum of 10 mg. 5. Must have received at least 2 consecutive cycles of a bortezomib- or carfilzomib-containing regimen, and either: - Achieved at least a partial response (PR) and did not have PD during treatment with or within 60 days after the last dose of bortezomib or carfilzomib, OR - Had bortezomib and/or carfilzomib intolerance (defined as discontinuation because of drug-related adverse events [AEs] before completion of the planned treatment course) without PD before the start of the next regimen. 6. Must have measurable disease defined by: - Serum M-protein >=1 g/dL (>=10 g/L), OR - Urine M-protein >=200 mg/24 hours and must have documented MM isotype by immunofixation (central laboratory). 7. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling. 8. Recovered (that is, less than or equal to [<=] Grade 1 nonhematologic toxicity) from the reversible effects of prior anticancer therapy. 9. Must be willing and able to adhere to pomalidomide-related risk mitigation activities if randomized to the pom+dex arm (example, Risk Evaluation and Mitigation Strategies [REMS], pregnancy prevention programs). Exclusion Criteria: 1. Prior allogenic bone marrow transplantation in any prior line of therapy or prior autologous SCT in the last prior line of therapy- unless the autologous SCT was performed a year or more before disease progression. 2. Diagnosed with or treated for another malignancy within 2 years before randomization, or previously diagnosed with another malignancy and have any evidence of residual, persistent, or recurrent disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 3. Diagnosis of smoldering MM, Waldenström's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome. 4. Peripheral neuropathy Grade 1 with pain or Grade 2 or higher peripheral neuropathy of any cause on clinical examination during the Screening period. 5. Treatment with any investigational products or with chimeric or fully human monoclonal antibodies within 30 days before randomization, systemic anticancer therapy or radiotherapy within 14 days before randomization (Note: "spot" radiation for areas of pain is permitted), and major surgery within 14 days before randomization. 6. Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption or tolerance of study therapy, including difficulty swallowing. 7. Serious infection requiring parenteral antibiotic therapy or any other serious infection within 14 days before randomization. 8. Central nervous system involvement with MM (by clinical symptoms and signs). 9. Ongoing or active systemic infection, known human immunodeficiency virus-ribonucleic acid (RNA) positive, known hepatitis B surface antigen seropositive, or known hepatitis C virus-RNA positive. 10. Systemic treatment with strong cytochrome P-450 3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or use of St. John's wort within 14 days before randomization. 11. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse. 12. History of severe cutaneous reactions, including hypersensitivity reactions such as Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), in the context of treatment with lenalidomide or thalidomide.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ixazomib
Ixazomib capsules
Pomalidomide
Pomalidomide capsules
Dexamethasone
Dexamethasone tablets

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide
Australia Box Hill Hospital Box Hill Victoria
Australia St Vincents Hospital Melbourne Fitzroy Victoria
Australia Icon Cancer Care South Brisbane South Brisbane Queensland
Australia The Queen Elizabeth Hospital Woodville South South Australia
Belgium AZ St Jan Brugge Oostende AV Brugge
Belgium GasthuisZusters Antwerpen Wilrijk Antwerpen
Canada Royal Victoria Regional Health Centre Barrie Ontario
Canada Lakeridge Health Center Ottawa Ontario
Czechia Fakultni nemocnice Brno Brno
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove Kralovehradeck Kraj
Czechia University Hospital Olomouc Olomouc Olomouck Kraj
Czechia Fakultni nemocnice Ostrava Ostrava
Czechia Fakultni nemocnice Plzen Plzen Lochotin
Czechia Fakultni nemocnice Kralovske Vinohrady Prague Praha, Hlavni Mesto
Czechia Vseobecna fakultni nemocnice v Praze Praha Praha, Hlavni Mesto
Denmark Aalborg Universitetshospital Aalborg Nordjylland
Denmark Regionshospitalet Holstebro Holstebro
France CHU Amiens Hopital Sud Amiens
France Centre Hospitalier Fleyriat Bourg-en- Bresse Cedex
France CHRU de Brest - Hopital Morvan Brest Finistere
France Centre Hospitalier (CH) William Morey Chalon sur Saone
France Hospital d Instructions des Armees Percy Clamart
France CHRU Dijon Complexe Du Bocage Dijon Cote-d'Or
France Centre Hospitalier de Dunkerque Dunkerque
France Centre Hospitalier Le Mans Le Mans Sarthe
France Centre Jean Bernard Clinique Victor Hugo Le Mans cedex 2
France Groupe Hospitalier du Havre Montivilliers Seine-Maritime
France Centre Antoine Lacassagne Centre Regional de Lutte Contre Le Cancer Nice Alpes-Maritimes
France Centre Hospitalier Regional d'Orleans Orleans
France Centre Hospitalier de Perigueux Perigueux
France CHRU de Poitiers La Miletrie Poitiers
France CHRU Rennes Rennes Cedex 9
France Centre Henri Becquerel Rouen
France CHRU Nancy Vandoeuvre Les Nancy Meurthe-et-Moselle
France Centre Hospitalier Bretagne Atlantique Vannes Vannes Morbihan
Germany Universitatsklinikum Dusseldorf Dusseldorf
Germany Asklepios Klinik Altona Hamburg
Germany Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck Munchen Bayern
Germany Universitatsklinikum Tubingen Tubingen
Greece University Hospital of Alexandroupolis Alexandroupoli
Greece Alexandra Hospital Athens
Greece Evangelismos General Hospital of Athens Athens
Greece University General Hospital of Ioannina Ioannina
Greece University General Hospital of Patras Patra Achaia
Greece Theageneio Anticancer Oncology Hospital of Thessaloniki Thessaloniki
Israel Soroka University Medical Centre Beer Sheva
Israel Bnai Zion Medical Center Haifa
Israel Lady Davis Carmel Medical Center Haifa
Israel Rambam Health Corporation Haifa
Israel Hadassah Medical Center Jerusalem
Italy Centro Di Riferimento Oncologico Aviano
Italy Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi Bologna Emilia-Romagna
Italy ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia Brescia
Italy Fondazione del Piemonte per lOncologia (IRCCS) Candiolo Piemonte
Italy Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST Meldola
Italy Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milano
Italy Azienda Ospedaliero Universitaria Di Modena Policlinico Modena
Italy Azienda Sanitaria Ospedaliera S Luigi Gonzaga Orbassano Piemonte
Italy Azienda Ospedaliero Universitaria di Parma Parma
Italy Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro Marche
Italy Ospedale Santa Maria Delle Croci Ravenna Emilia-Romagna
Italy Arcispedale Santa Maria Nuova Reggio Emilia Emilia-Romagna
Italy Ospedale Infermi di Rimini Rimini Emilia-Romagna
Italy Centro Di Riferimento Oncologico Della Basilicata Rionero in Vulture PZ
Italy Azienda Ospedaliera Citta della Salute e della Scienza di Torino Torino Piemonte
Italy Ospedale Santa Maria Della Misericordia Udine
Italy Azienda ULSS 6 Vicenza Vicenza
Netherlands Albert Schweitzer Ziekenhuis Dordrecht Zuid-Holland
Netherlands Zuyderland Medisch Centrum Sittard
Norway Haukeland Universitetssykehus Bergen
Norway Forde Sentralsjukehus Forde
Norway Oslo Universitetssykehus HF Rikshospitalet Oslo Oppland
Norway Stavanger Universitetssykehus Stavanger
Norway St Olavs Hospital Trondheim
Russian Federation Kirov Research Institute of Haematology and Blood Transfusion Kirov
Russian Federation City Clinical Hospital # 40 Moscow
Russian Federation City Clinical Hospital n a S P Botkin Moscow
Russian Federation Moscow Clinical Scientific Center Moscow
Russian Federation Samara State Medical University Samara
Spain Hospital Universitari de Girona Dr Josep Trueta Girona
Spain Hospital Universitario Infanta Leonor Madrid Madrid, Communidad Delaware
Spain Hospital Clinico Universitario de Valencia Valencia
Sweden Sodra Alvsborgs Sjukhus Boras Boras
Sweden Helsingborg Lasarett Helsingborg Skane Lan
Sweden Norrlands Universitetssjukhus Umea
Turkey Ankara University Medical Faculty Cebeci Hospital Ankara
Turkey Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi Ankara
Turkey Gazi University Medical Faculty Gazi Hospital Ankara
Turkey Dokuz Eylul University Medical Faculty Izmir
Turkey Ege Universitesi Tip Fakultesi Hastanesi Izmir
Turkey Erciyes Universitesi Tip Fakultesi Hastanesi Kayseri
United Kingdom Betsi Cadwaladr University Health Board Bodelwyddan Denbighshire-SirDdinbych
United Kingdom Royal Bournemouth Hospital Bournemouth Dorset
United Kingdom Kent and Canterbury Hospital Canterbury Kent
United Kingdom Leicester Royal Infirmary Leicester
United Kingdom GenesisCare Oxford Oxford Oxfordshire
United Kingdom Royal Stoke University Hospital Stoke-on-Trent Staffordshire
United Kingdom Singleton Hospital Swansea
United Kingdom Royal Cornwall Hospital Truro Cornwall
United Kingdom New Cross Hospital Wolverhampton
United States University of Maryland Baltimore Maryland
United States Lynn Cancer Institute Boca Raton Florida
United States Henry Ford Health System Detroit Michigan
United States San Juan Oncology Associates Farmington New Mexico
United States Highlands Oncology Group Fayetteville Arkansas
United States University of Florida Gainesville Florida
United States Michigan State University Lansing Michigan
United States Mayo Clinic Rochester Minnesota
United States St Joseph Heritage Healthcare Santa Rosa California
United States University of Toledo Medical Center Toledo Ohio

Sponsors (1)

Lead Sponsor Collaborator
Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Norway,  Russian Federation,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) PFS: Time from randomization to first occurrence of confirmed progressive disease (PD) as assessed by investigator by International Myeloma Working Group(IMWG) response criteria/death from any cause, whichever occurs first. PD requires following: Increase of >=25 % from nadir in: Serum M component (increase must be >=0.5 gram per deciliter [g/dl]); Urine M-component (increase must be >=200 milligram [mg]/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved free light chain (FLC) increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: bone marrow plasma cell percentage must be >=10%; Development of new/increase in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia (>11.5mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease. From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
Secondary Overall Survival (OS) OS was defined as the time from randomization to death from any cause, up to 3 years are reported. From date of randomization to death due to any cause (Up to approximately 3 years)
Secondary Percentage of Participants With Overall Response Overall Response Rate (ORR) was defined as the percentage of participants who achieved partial response (PR), very good partial response (VGPR), or complete response (CR) based on laboratory results and IRC assessment using modified IMWG criteria. PR: >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when baseline value >=30% and; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5 % plasma cells in bone marrow. From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)
Secondary Duration of Response (DOR) DOR: Time from first documentation of CR/PR/VGPR to first documentation of PD. Per IMWG criteria, PR:>=50% reduction of serum M protein+reduction in 24-hour urinary M protein by >=90% to <200 mg/24-hour or >=50% decrease in difference between involved and uninvolved FLC levels/ >=50% reduction in bone marrow plasma cells, if >=30% at Baseline/ >=50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR:negative immunofixation on serum + urine+disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow. PD:serum M-component increase >=0.5 g/dl or urine M-component increase >=200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell >=10%/development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia. From date of first documentation of CR, VGPR or PR until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
Secondary Time to Response Time to response was defined as the time from randomization to the first documentation of PR/VGPR/CR. Per IMWG criteria, PR: >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M-protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when Baseline value >=30% and; if present at Baseline, >=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5% plasma cells in bone marrow. From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)
Secondary Time to Progression (TTP) TTP was defined as the time from the date of randomization to first documentation of PD. Per IMWG criteria, PD required 1 of the following: Increase of >=25% from nadir in: Serum M-component (increase must be >=0.5 g/dl; Urine M-component (increase must be >=200 mg/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved FLC levels increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: Bone marrow plasma cell percentage must be >=10%; Development of new or increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease. From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
Secondary Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. The physical domain consisted of 5 items covering participant's daily physical activities on a scale from 1 (not at all) to 4 (very much). Raw scores were linearly transformed to a total score between 0-100, with a high score indicating better physical functioning. Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary HRQOL Based on EORTC QLQ-C30 SubScale Score The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a QOL scale. Most of the 30 items had 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Each subscale raw score were linearly transformed to a total score between 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The Physical domain of the functional subscale is reported in the secondary outcome measure 7. Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 symptoms scales (disease symptoms, side effects of treatment), and 2 functional subscales (body image, future perspective). Scores were averaged and transformed to 0-100 scale. Higher scores for the future perspective scale indicate better perspective of the future, for the body image scale indicate better body image and for the disease symptoms scale indicate higher level of symptomatology. Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score EQ-5D-5L comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, 5= extremely severe problems. Higher scores indicated greater levels of problems across the five dimensions. End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) Score The EQ VAS records the respondent's self-rated health on a 20 centimeter (cm), vertical, visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores from all dimensions were combined into a single index score that was reported, where higher score was better quality of life. Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter Healthcare resources used during medical encounters included hospitalizations, emergency room stays, or outpatient visits. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice). Up to approximately 3 years
Secondary HU: Duration of Medical Encounters Duration of healthcare resources used during medical encounters including hospitalizations, emergency room stays, or outpatient visits was reported in days. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice). Up to approximately 3 years
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