Multiple Myeloma Clinical Trial
Official title:
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Verified date | August 2023 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Takeda |
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,
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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