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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02181413
Other study ID # C16019
Secondary ID U1111-1155-86952
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 1, 2014
Est. completion date July 31, 2024

Study information

Verified date August 2023
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).


Description:

The investigational drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow disease progression and improve overall survival in people who have NDMM and who have had any type of positive response to induction therapy followed by HDT and ASCT. This study will look at the effect ixazomib citrate has on the length of time that participants are free of progressive disease (PD) and their overall survival (OS). The study enrolled 656 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need, or if the disease has progressed and the information is required for planning the next treatment): - Ixazomib citrate 3 mg for the first 4 cycles, then 4 mg for the remaining 22 cycles - Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient. All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle, for up to 26 cycles (approximately 24 months). This multi-center trial will be conducted globally. The overall time to participate in this study is up to 107 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make visits after treatment has ended. During this initial follow up period, participants will be assessed for disease status with follow up every 12 weeks. After the next line of therapy begins, follow-up will occur every 12 weeks until death or termination of the study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 656
Est. completion date July 31, 2024
Est. primary completion date April 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic multiple myeloma according to standard criteria. 2. Documented results of cytogenetics/ fluorescence in situ hybridization (FISH) obtained at any time before transplant, and International Staging System (ISS) staging at the time of diagnosis available. 3. Underwent standard of care (SOC) induction therapy (induction therapy must include proteasome inhibitor (PI) and/or immunomodulating drugs (IMiD)-based regimens as primary therapy for multiple myeloma), followed by a single autologous stem cell transplant (ASCT) with a high-dose melphalan (200 mg/m^2) conditioning regimen, within 12 months of diagnosis. Vincristine, Adriamycin [doxorubicin], and dexamethasone (VAD) is not an acceptable induction therapy for this trial. 4. Started screening no earlier than 75 days after transplant, completed screening within 15 days, and randomized no later than 115 days after transplant. 5. Must have not received post-ASCT consolidation therapy. 6. Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR]) according to IMWG criteria. 7. ECOG performance status of 0 to 2. 8. Female participants who: - If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, AND - Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who: - Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, AND - Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.) 9. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. 10. Suitable venous access for the study-required blood sampling. 11. Is willing and able to adhere to the study visit schedule and other protocol requirements. 12. Must meet the following clinical laboratory criteria at study entry: - Absolute neutrophil count (ANC) = 1,000 per cubic milliliter (/mm^3) and platelet count = 75,000/mm^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before randomization. - Total bilirubin = 1.5 * the upper limit of the normal range (ULN). - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 * ULN. - Calculated creatinine clearance = 30 milliliter per minute (mL/min). Exclusion Criteria: 1. Multiple myeloma that has relapsed following primary therapy or is not responsive to primary therapy. For this study, stable disease following ASCT will be considered nonresponsive to primary therapy. 2. Double (tandem) ASCT. 3. Radiotherapy within 14 days before the first dose of study drug. 4. Diagnosed or treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy with evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 5. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period. 6. Major surgery within 14 days before randomization. 7. Central nervous system involvement. 8. Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization. 9. Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome. 10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. 11. Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort within 14 days before randomization in the study. 12. Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive. 13. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause). 14. Psychiatric illness/social situation that would limit compliance with study requirements. 15. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. 16. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment. 17. Treatment with any investigational products within 60 days before the first dose of the study drug regimen.

Study Design


Intervention

Drug:
Ixazomib Citrate
Ixazomib citrate capsules
Placebo
Ixazomib citrate placebo-matching capsules

Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires Ciudad Autonoma de Buenos Aires
Argentina Hospital Italiano de La Plata La Plata Buenos Aires
Argentina Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli Rosario Santa Fe
Argentina Sanatorio Britanico de Rosario Rosario Santa Fe
Argentina Sanatorio Parque de Rosario Rosario Santa Fe
Argentina Hospital Iturraspe Santa Fe
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Austin Health Heidelberg Victoria
Australia St George Hospital Kogarah New South Wales
Australia The Alfred Hospital Melbourne Victoria
Australia Icon Cancer Care South Brisbane South Brisbane Queensland
Australia Gold Coast University Hospital Southport Queensland
Australia Calvary Mater Newcastle Waratah New South Wales
Australia Westmead Hospital Westmead New South Wales
Australia The Queen Elizabeth Hospital Woodville South South Australia
Austria Elisabethinen Hospital Linz Linz
Austria Salzburger Landeskliniken Salzburg
Austria Allgemeines Krankenhaus der Stadt Wien Wien
Austria Klinik Ottakring (fruher: Wilhelminenspital) Wien
Belgium ZNA Middelheim Antwerpen
Belgium ZNA Stuivenberg Antwerpen
Belgium AZ Sint-Jan AV Brugge West-Vlaanderen
Belgium UZ Gent Gent Oost-Vlaanderen
Belgium Centre Hospitalier Jolimont-Lobbes La Louviere Hainaut
Belgium Centre Hospitalier Universitaire Ambroise Pare Mons Hainaut
Brazil Hospital Das Clinicas Da Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais
Brazil Instituto de Oncologia Do Parana Curitiba Parana
Brazil Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner Curitiba Parana
Brazil Centro de Pesquisas Oncologicas Florianopolis Santa Catarina
Brazil Hospital Amaral Carvalho Jau Sao Paulo
Brazil Instituto Joinvilense de Hematologia E Oncologia Joinville Santa Catarina
Brazil Hospital de Clinicas de Passo Fundo Passo Fundo Rio Grande Do Sul
Brazil Hospital de Clinicas de Porto Alegre (HCPA) - PPDS Porto Alegre Rio Grande Do Sul
Brazil Mae de Deus Center Hospital Giovanni Battista Porto Alegre Rio Grande Do Sul
Brazil Instituto Nacional de Cancer Rio De Janeiro
Brazil Universidade Federal do Rio de Janeiro - UFRJ Rio de Janeiro
Brazil Hospital de Base Da FAMERP Sao Jose Do Rio Preto Sao Paulo
Brazil Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Sao Paulo
Brazil Hospital Israelita Albert Einstein Sao Paulo
Brazil Irmandade Da Santa Casa de Misericordia de Sao Paulo Sao Paulo
Canada MUHC-Glen Site Montreal Quebec
Canada University Health Network Toronto Ontario
Colombia Instituto Nacional de Cancerologia Colombia Bogota Cundinamarca
Colombia Fundacion Valle Del Lili Cali Valle Del Cauca
Colombia Hospital Pablo Tobon Uribe Medellin
Czechia Fakultni nemocnice Brno Brno
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove Kralovehradeck Kraj
Czechia Fakultni nemocnice Olomouc Olomouc
Czechia Fakultni nemocnice Ostrava Ostrava
Czechia Fakultni nemocnice Kralovske Vinohrady Praha
Czechia Vseobecna Fakultni Nemocnice V Praze Praha 2
Denmark Aalborg Universitetshospital Aalborg Nordjylland
Denmark Aarhus Universitetshospital Arhus Sygehus Aarhus N
Denmark Rigshospitalet Copenhagen
Denmark Herlev Hospital Herlev Capital
Denmark Odense Universitetshospital Odense
Denmark Sjallands Universitetshospital, Roskilde Roskilde
Denmark Vejle Sygehus Vejle
France Hopital Antoine Beclere Clamart Hauts-de-Seine
France CHRU Lille Lille Nord
France Hopital Universitaire Dupuytren Limoges
France Hotel Dieu - Nantes Nantes Loire-Atlantique
France Groupe Hospitalier Necker Enfants Malades Paris
Germany Charite - Universitatsmedizin Berlin Berlin
Germany Helios Klinikum Berlin-Buch Berlin
Germany Universitatsklinikum Bonn Bonn Nordrhein-Westfalen
Germany Klinikum Darmstadt GmbH Darmstadt Hessen
Germany Universitatsklinikum Carl Gustav Carus an der TU Dresden Dresden Sachsen
Germany Evangelisches Krankenhaus Essen Werden gGmbH Essen Nordrhein-Westfalen
Germany Universitatsklinikum Essen Essen Nordrhein-Westfalen
Germany Klinikum Frankfurt Hochst GmbH Frankfurt am Main Hessen
Germany Katholisches Krankenhaus Hagen gGmbH Hagen Nordrhein-Westfalen
Germany Asklepios Klinik Altona Hamburg
Germany Asklepios Klinik St. Georg Hamburg
Germany Universitatsklinikum Hamburg Eppendorf Hamburg
Germany KRH Klinikum Siloah-Oststadt-Heidehaus Hannover
Germany University Clinic Heidelberg Heidelberg Baden-Wurttemberg
Germany Uniklinik Koln Koln Nordrhein-Westfalen
Germany Klinikum der Stadt Ludwigshafen gGmbH Ludwigshafen
Germany Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Mainz Rheinland-Pfalz
Germany Klinikum Mannheim Universitatsklinikum gGmbH Mannheim Baden-Wurttemberg
Germany LMU Klinikum der Universitat Munchen Munchen Bayern
Germany Pius Hospital Oldenburg Oldenburg Niedersachsen
Germany Universitatsklinikum Tubingen Tubingen
Germany Universitatsklinikum Ulm Ulm Baden-Wurttemberg
Germany Universitatsklinikum Wurzburg Wurzburg Bayern
Greece Alexandra Hospital Athens
Greece Evangelismos General Hospital of Athens Athens Attiki
Greece Laiko General Hospital of Athens Athens Attiki
Greece Georgios Papanikolaou General Hospital of Thessaloniki Thessaloniki
Hungary Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged
Israel Barzilai Medical Center Ashkelon
Israel Soroka University Medical Centre Be'er Sheva
Israel Bnai Zion Medical Center Haifa
Israel Lady Davis Carmel Medical Center Haifa
Israel Rambam Medical Center - PPDS Haifa
Israel Hadassah Medical Center PPDS - Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Galilee Medical Center Nahariya
Israel Rabin Medical Center - PPDS Petach Tikva
Israel Sheba Medical Center - PPDS Ramat-Gan
Israel Kaplan Medical Center Rehovot
Israel ZIV Medical Center Safed
Israel Tel Aviv Sourasky Medical Center PPDS Tel Aviv
Israel Shamir Medical Center Assaf Harofeh Tzrifin
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi Ancona Marche
Italy Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi Bologna
Italy ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN Brescia
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy IRCCS Az. Osp. Universitaria San Martino- IST Genova
Italy Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS Meldola
Italy ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Milano
Italy Fondazione IRCCS Policlinico San Matteo di Pavia Pavia Lombardia
Italy Presidio Ospedaliero di Pescara Pescara Abruzzo
Italy Ospedale Infermi di Rimini Rimini
Italy IRCCS Centro Di Riferimento Oncologico Della Basilicata Rionero In Vulture Potenza
Italy Azienda Ospedaliera San Camillo Forlanini Roma Lazio
Italy Azienda Ospedaliera S Maria Di Terni Terni Umbria
Italy Azienda Ospedaliera Citta della Salute e della Scienza di Torino Torino Piemonte
Japan Juntendo University Hospital Bunkyo Tokyo
Japan Chiba University Hospital Chiba Tokyo
Japan Kyushu University Hospital Fukuoka-City
Japan Saitama Medical Center Kawagoe-city Saitama
Japan Kobe City Medical Center General Hospital Kobe-City Hyogo
Japan Iwate Medical University Hospital Morioka-shi Iwate
Japan National Hospital Organization Nagoya Medical Center Nagoya
Japan Nagoya City University Hospital Nagoya-City
Japan Niigata Cancer Center Hospital Niigata-shi Niigata
Japan National Hospital Organization Okayama Medical Center Okayama-City Okayama
Japan National Hospital Organization Sendai Medical Center Sendai Miyagi
Japan National Hospital Organaization Shibukawa Medical Center Shibukawa
Japan Japanese Red Cross Medical Center Shibuya-ku Tokyo
Japan Center Hospital of the National Center for Global Health and Medicine Shinjuku Tokyo
Japan Keio University Hospital Shinjuku-ku Tokyo
Japan National Hospital Organization Disaster Medical Center Tachikawa
Japan Toyohashi Municipal Hospital Toyohashi-City
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of National Cancer Center Goyang Gyeonggido
Korea, Republic of Gachon University Gil Medical Center Pharmacy Incheon
Korea, Republic of Asan Medical Center - PPDS Seoul
Korea, Republic of Ewha Womans University Mokdong Hospital Seoul
Korea, Republic of Samsung Medical Center - PPDS Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Yonsei University Health System - PPDS Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul
Mexico Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS Guadalajara Jalisco
Mexico Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey Nuevo Leon
Netherlands VU Medisch Centrum Amsterdam Noord-Holland
Netherlands Albert Schweitzer Ziekenhuis Dordrecht Zuid-Holland
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Erasmus MC Rotterdam
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Norway Vestre Viken HF Sykehuset Asker Og Barum Gjelta Oppland
Norway Oslo Universitetssykehus HF, Ulleval Oslo
Norway Stavanger Universitetssykehus Stavanger
Norway St. Olav's University Hospital Trondheim Sor-Trondelag
Poland Szpital Specjalistyczny w Brzozowie Brzozow
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Chorzow Slaskie
Poland Uniwersyteckie Centrum Kliniczne Gdansk Pomorskie
Poland Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz
Poland Wojskowy Instytut Medyczny Warszawa Mazowieckie
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu Wroclaw Dolnoslaskie
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar E Universitario de Coimbra EPE Coimbra
Portugal Centro Hospitalar de Sao Joao, E.P.E. Porto
Portugal Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS Porto
Singapore National University Hospital Singapore
Singapore Singapore General Hospital (SGH) Singapore
South Africa Medical Oncology Centre of Rosebank Johannesburg Gauteng
South Africa Albert Alberts Stem Cell Transplant Centre Pretoria Gauteng
South Africa Mary Potter Oncology Centre Pretoria Gauteng
Spain Hospital Universitario Germans Trias i Pujol Badalona Barcelona
Spain Hospital Clinic de Barcelona Barcelona
Spain C.H. Regional Reina Sofia - PPDS Cordoba
Spain Institut Catala d'Oncologia Girona Girona
Spain Hospital General Universitario Gregorio Maranon Madrid Madrid, Communidad Delaware
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Universitario HM Sanchinarro CIOCC Madrid
Spain Hospital Universitario La Paz - PPDS Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda Madrid
Spain Hospital General Universitario Morales Meseguer Murcia
Spain Clinica Universidad Navarra Pamplona Navarra
Spain Complejo Asistencial Universitario de Salamanca H. Clinico Salamanca
Spain Hospital Universitario Virgen del Rocio - PPDS Sevilla
Sweden Sahlgrenska Universitetssjukhuset Goteborg Vastra Gotalands Lan
Sweden Helsingborg Lasarett Helsingborg Skane Lan
Sweden Skanes Universitetssjukhus Lund Lund Skane Lan
Sweden Karolinska Universitetssjukhuset Huddinge Stockholm
Sweden Akademiska Sjukhuset I Uppsala Uppsala
Switzerland Universitatsspital Basel Basel Basel-Stadt (de)
Switzerland Universitatsspital Zurich Zurich Zurich (de)
Taiwan Chang Gung Medical Foundation-Kaoshiung Branch Kaohsiung
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Memorial Hospital, Linkou Taoyuan City
Thailand Chulalongkorn University Bangkok Krung Thep Maha Nakhon-Bangkok
Thailand Phramongkutklao Hospital Bangkok Krung Thep Maha Nakhon-Bangkok
Turkey Ankara University Medical Faculty PPDS Ankara
Turkey Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi Ankara
Turkey Hacettepe Universitesi Tip Fakultesi Hastanesi Ankara
Turkey Pamukkale Universitesi Tip Fakultesi Hastanesi Denizli
Turkey Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi Istanbul
Turkey Erciyes Universitesi Tip Fakultesi Hastanesi Kayseri
Turkey Karadeniz Technical University Faculty of Medicine Trabzon
Ukraine MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council Kyiv
United Kingdom St James University Hospital Leeds Yorkshire
United Kingdom University Hospitals Leicester Leicester
United Kingdom Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre London London, City Of
United Kingdom Imperial College Healthcare NHS Trust London London, City Of
United Kingdom Kings College Hospital London London, City Of
United Kingdom University College London Hospitals (UCLH) London
United Kingdom Churchill Hospital Oxford Oxfordshire
United Kingdom Royal Hallamshire Hospital Sheffield Yorkshire
United Kingdom Southampton General Hospital Southampton Hampshire
United Kingdom Royal Marsden Hospital - Surrey Sutton Surrey
United Kingdom Singleton Hospital - PPDS Swansea
United States Montefiore Medical Center Bronx New York
United States Baylor University Medical Center Dallas Texas
United States Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States West Virginia University Hospital Morgantown West Virginia
United States Mayo Clinic - PPDS Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD), as evaluated by an independent review committee according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occured first. PD was defined as =25% increase from lowest value in: serum/urine M component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels must be >10 mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must have been =10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size increase; hypercalcemia development. Randomization up to End of treatment (EOT) (24 months); thereafter followed up every 4 weeks until progression of disease or death (to data cutoff: approximately 4 years)
Secondary Overall Survival (OS) OS was measured as the time from the date of randomization to the date of death. Baseline up to Follow up period (107 months)
Secondary Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy Response was assessed according to IMWG criteria. Best response includes PR, VGPR and CR. PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by greater than or equal to (>=) 90% or to less than (<) 200 milligram (mg) per 24 hours. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. CR is negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. Stringent CR (sCR) is CR and normal FLC ratio and absence of clonal PCs by immunohistochemistry or 2- to 4-color flow cytometry. Baseline up to EOT (24 months) and thereafter every 4 weeks until initiation of the next line of therapy (up to 107 months)
Secondary Time to Progression (TTP) TTP is defined as the time from the date of randomization to the date of first documentation of PD , using IMWG criteria. PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. Baseline until PD (Month 107)
Secondary Second Progression Free Survival (PFS2) PFS2 is defined as the time from the date of randomization to the date of objective disease progression on next line treatment or death from any cause (whichever occurs first). PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. Baseline up to EOT (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to Month 107)
Secondary Time to Start of the Next Line of Therapy Time to start of the next line of therapy was defined as the time from the date of randomization to the date of initiation dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurs first. Baseline up to start of next line of therapy (after 24 months treatment period followed by every 4 weeks PFS and PD follow up period)
Secondary Time to End of the Next Line of Therapy Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurs first. Baseline up to end of next line of therapy (Month 107)
Secondary Duration of the Next Line of Therapy Duration of the next line of therapy is defined as the time from the date of the first dose of the next line of therapy to the date of the last dose of the next antineoplastic therapy following study treatment or death due to any cause, whichever occurs first. Duration of the next line of therapy will be analyzed on those participants who actually received the next line of therapy following the study treatment and duration would be summarized using Kaplan-Meier method. Participants who are still on treatment on the next line of therapy will be censored at last visit. From the start of next line therapy after PD to the last dose of next line therapy (up to Month 107)
Secondary Percentage of Participants Who Develop A New Primary Malignancy Baseline until death or termination of the study (up to Month 107)
Secondary Number of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative, and Maintenance of MRD Negativity MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. The conversion rate from MRD positive to MRD negative and the maintenance of MRD negativity will be assessed and reported. Bone marrow aspirates and blood samples will be sent to a central laboratory and will be assessed for MRD using flow cytometry and a sequencing methodology. Baseline up to EOT (24 months)
Secondary Correlation Between MRD Status and Progression Free Survival (PFS) and Overall Survival (OS) Degree of correlation will be determined between 2 methodologies for MRD assessment (8-color flow cytometry, next-generation sequencing and bone marrow aspirates and blood samples). Association between MRD status with PFS and OS will be evaluated independently from the methodology used for the assessment. The association between MRD status and PFS and OS will be evaluated in both study arms, and concordance between flow cytometry and sequencing readouts will be assessed. Baseline up to Month 107
Secondary OS Benefits in a High-Risk Population High-risk population will include but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS will be measured as the time from the date of randomization to the date of death. Randomization up to Month 107
Secondary PFS Benefits in a High-Risk Population High-risk population will include but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. PFS is defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee according to IMWG criteria, or death due to any cause (whichever occurs first). PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. Randomization up to Month 107
Secondary Eastern Cooperative Oncology Group (ECOG) Performance Score The ECOG performance is a 6-point scale used by doctors to assess how a participant's disease is progressing, how the disease affects the participant's daily life, and to determine appropriate treatment and prognosis. The scale is 0=Normal activity. Fully active, able to carry on all pre disease performance without restriction (best) to 5=Dead. Baseline up to EOT (24 months), thereafter every 4 weeks until initiation of next line therapy
Secondary Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) or Serious Adverse Events (SAEs) First dose of study drug through 30 days after last dose of study drug (up to 24 months)
Secondary Number of Participants With Markedly Abnormal Clinical Laboratory Values Baseline through 30 days after the last dose of study drug (up to 24 months)
Secondary Health-related Quality of Life (HRQL) Score Based on The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Quality of Life Domain EORTC QLQ-C30 is completed by the participants. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). Baseline up to PD (up to Month 107)
Secondary Plasma Concentration of Ixazomib Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) will be measured using a validated Liquid Chromatography-tandem Mass Spectrometry (LC/MS/MS) assay. Day 1 of Cycle 1 at multiple time points (up to 4 hours) post-dose; Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle of 28 days) predose
Secondary Time to Resolution of Peripheral Neuropathy (PN) Events Peripheral neuropathy is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first. From randomization date through 30 days after the last dose of drug (up to 24 months)
Secondary Time to Improvement of PN Events PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as resolved if its final outcome is resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first. From randomization date through 30 days after the last dose of drug (up to 24 months)
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