Clinical trial NCT02181413: A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Autologous Stem Cell Transplant
Keywords: Drug therapy
Ixazomib citrate
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Randomization up to End of treatment (EOT) (24 months); thereafter followed up every 4 weeks (up to 45 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization up to end of follow up period (up to 107 months)
measure: Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy
timeFrame: Randomization up to EOT (up to 24 months) and thereafter every 4 weeks until initiation of the next line of therapy (up to 107 months)
measure: Time to Progression (TTP)
timeFrame: Randomization up to PD (up to 107 months)
measure: Second Progression Free Survival (PFS2)
timeFrame: Randomization 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 107 months)
measure: Time to Start of the Next Line of Therapy
timeFrame: Randomization up to 107 months
measure: Time to End of the Next Line of Therapy
timeFrame: Randomization up to 107 months
measure: Duration of the Next Line of Therapy
timeFrame: Up to 107 months
measure: Percentage of Participants Who Develop a New Primary Malignancy
timeFrame: Up to 107 months
measure: Number of Participants With Conversion to Minimal Residual Disease (MRD) Negative
timeFrame: Baseline up to EOT (up to 24 months)
measure: Number of Participants With Maintenance of MRD Negativity
timeFrame: Up to EOT (up to 24 months)
measure: Correlation Between MRD Status and Progression Free Survival (PFS)
timeFrame: From randomization up to 107 months
measure: Correlation Between MRD Status and Overall Survival (OS)
timeFrame: From randomization up to 107 months
measure: OS Benefits in a High-Risk Population
timeFrame: Randomization up to 107 months
measure: PFS Benefits in a High-Risk Population
timeFrame: Randomization up to 107 months
measure: Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
timeFrame: Baseline up to EOT (up to Month 24)
measure: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) or Serious Adverse Events (SAEs)
timeFrame: Up to 107 months
measure: Number of Participants With Markedly Abnormal Clinical Laboratory Values Reported as TEAEs
timeFrame: Up to 107 months
measure: Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Domain Score
timeFrame: Baseline up to EOT (up to Month 24)
measure: Plasma Concentration of Ixazomib
timeFrame: Day 1 of Cycle 1: 1 hour and 4 hours post-dose; Predose on Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle length= 28 days)
measure: Time to Resolution of Peripheral Neuropathy (PN) Events
timeFrame: Up to 107 months
measure: Time to Improvement of PN Events
timeFrame: Up to 107 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Rochester
country: United States
facility: Mayo Clinic - PPDS
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli
state: Santa Fe
city: Rosario
country: Argentina
facility: Sanatorio Britanico de Rosario
state: Santa Fe
city: Rosario
country: Argentina
facility: Sanatorio Parque de Rosario
state: Santa Fe
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Santa Fe
country: Argentina
facility: Hospital Iturraspe
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Linz
country: Austria
facility: Elisabethinen Hospital Linz
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Wien
country: Austria
facility: Klinik Ottakring (fruher: Wilhelminenspital)
city: La Louviere
country: Belgium
facility: Centre Hospitalier Jolimont-Lobbes
state: Hainaut
city: Mons
country: Belgium
facility: Centre Hospitalier Universitaire Ambroise Pare
state: Hainaut
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan AV
state: West-Vlaanderen
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Belo Horizonte
country: Brazil
facility: Hospital Das Clinicas Da Universidade Federal de Minas Gerais
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Instituto de Oncologia Do Parana
state: Parana
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
state: Parana
city: Passo Fundo
country: Brazil
facility: Hospital de Clinicas de Passo Fundo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Mae de Deus Center Hospital Giovanni Battista
state: Rio Grande Do Sul
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas
state: Santa Catarina
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia E Oncologia
state: Santa Catarina
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Hospital de Base Da FAMERP
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cancer
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro - UFRJ
city: Sao Paulo
country: Brazil
facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: MUHC-Glen Site
state: Quebec
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia Colombia
state: Cundinamarca
city: Cali
country: Colombia
facility: Fundacion Valle Del Lili
state: Valle Del Cauca
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
state: Kralovehradeck Kraj
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice V Praze
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Capital
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
state: Nordjylland
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Arhus Sygehus
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Roskilde
country: Denmark
facility: Sjallands Universitetshospital, Roskilde
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Clamart
country: France
facility: Hopital Antoine Beclere
state: Hauts-de-Seine
city: Nantes
country: France
facility: Hotel Dieu - Nantes
state: Loire-Atlantique
city: Lille
country: France
facility: CHRU Lille
state: Nord
city: Limoges
country: France
facility: Hopital Universitaire Dupuytren
city: Paris
country: France
facility: Groupe Hospitalier Necker Enfants Malades
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg
state: Baden-Wurttemberg
city: Mannheim
country: Germany
facility: Klinikum Mannheim Universitatsklinikum gGmbH
state: Baden-Wurttemberg
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
state: Baden-Wurttemberg
city: Munchen
country: Germany
facility: LMU Klinikum der Universitat Munchen
state: Bayern
city: Wurzburg
country: Germany
facility: Universitatsklinikum Wurzburg
state: Bayern
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Klinikum Frankfurt Hochst GmbH
state: Hessen
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitatsklinikum Essen
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Evangelisches Krankenhaus Essen Werden gGmbH
state: Nordrhein-Westfalen
city: Hagen
country: Germany
facility: Katholisches Krankenhaus Hagen gGmbH
state: Nordrhein-Westfalen
city: Koln
country: Germany
facility: Uniklinik Koln
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden
state: Sachsen
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hannover
country: Germany
facility: KRH Klinikum Siloah-Oststadt-Heidehaus
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen gGmbH
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attiki
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
state: Attiki
city: Athens
country: Greece
facility: Alexandra Hospital
city: Thessaloniki
country: Greece
facility: Georgios Papanikolaou General Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Centre
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center - PPDS
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center PPDS -
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - PPDS
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center - PPDS
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Safed
country: Israel
facility: ZIV Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center PPDS
city: Tzrifin
country: Israel
facility: Shamir Medical Center Assaf Harofeh
city: Pescara
country: Italy
facility: Presidio Ospedaliero di Pescara
state: Abruzzo
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
state: Lombardia
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
state: Marche
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino
state: Piemonte
city: Rionero In Vulture
country: Italy
facility: IRCCS Centro Di Riferimento Oncologico Della Basilicata
state: Potenza
city: Terni
country: Italy
facility: Azienda Ospedaliera S Maria Di Terni
state: Umbria
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: IRCCS Az. Osp. Universitaria San Martino- IST
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini
city: Kobe-City
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Morioka-shi
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Okayama-City
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Kawagoe-city
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Bunkyo
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo
city: Fukuoka-City
country: Japan
facility: Kyushu University Hospital
city: Nagoya-City
country: Japan
facility: Nagoya City University Hospital
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Shibukawa
country: Japan
facility: National Hospital Organaization Shibukawa Medical Center
city: Tachikawa
country: Japan
facility: National Hospital Organization Disaster Medical Center
city: Toyohashi-City
country: Japan
facility: Toyohashi Municipal Hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggido
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center Pharmacy
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo Leon
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
state: Noord-Holland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Gjelta
country: Norway
facility: Vestre Viken HF Sykehuset Asker Og Barum
state: Oppland
city: Trondheim
country: Norway
facility: St. Olav's University Hospital
state: Sor-Trondelag
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Ulleval
city: Stavanger
country: Norway
facility: Stavanger Universitetssykehus
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Chorzow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
state: Slaskie
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitario de Coimbra EPE
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, E.P.E.
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital (SGH)
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank
state: Gauteng
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Albert Alberts Stem Cell Transplant Centre
state: Gauteng
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
state: Madrid, Communidad Delaware
city: Pamplona
country: Spain
facility: Clinica Universidad Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
city: Girona
country: Spain
facility: Institut Catala d'Oncologia Girona
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro CIOCC
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca H. Clinico
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Helsingborg
country: Sweden
facility: Helsingborg Lasarett
state: Skane Lan
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus Lund
state: Skane Lan
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
state: Vastra Gotalands Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset I Uppsala
city: Basel
country: Switzerland
facility: Universitatsspital Basel
state: Basel-Stadt (de)
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
state: Zurich (de)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation-Kaoshiung Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Bangkok
country: Thailand
facility: Chulalongkorn University
state: Krung Thep Maha Nakhon-Bangkok
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
state: Krung Thep Maha Nakhon-Bangkok
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty PPDS
city: Denizli
country: Turkey
facility: Pamukkale Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi Hastanesi
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Medicine
city: Kyiv
country: Ukraine
facility: MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: London
country: United Kingdom
facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
state: London, City Of
city: London
country: United Kingdom
facility: Kings College Hospital
state: London, City Of
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: London, City Of
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: Oxfordshire
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital - Surrey
state: Surrey
city: Leeds
country: United Kingdom
facility: St James University Hospital
state: Yorkshire
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: Yorkshire
city: Leicester
country: United Kingdom
facility: University Hospitals Leicester
city: London
country: United Kingdom
facility: University College London Hospitals (UCLH)
city: Swansea
country: United Kingdom
facility: Singleton Hospital - PPDS
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Kaiser M, Beksac M, Gulbrandsen N, Schjesvold F, Hajek R, Moreau P, de Arriba de la Fuente F, Mateos MV, West S, Spencer A, Rajkumar SV, Suryanarayan K, Czorniak M, Li C, Teng Z, Labotka R, Dimopoulos MA. Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma. Ann Hematol. 2020 Aug;99(8):1793-1804. doi: 10.1007/s00277-020-04149-5. Epub 2020 Jul 1.
citation: Schjesvold F, Goldschmidt H, Maisnar V, Spicka I, Abildgaard N, Rowlings P, Cain L, Romanus D, Suryanarayan K, Rajkumar V, Odom D, Gnanasakthy A, Dimopoulos M. Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial. Eur J Haematol. 2020 May;104(5):443-458. doi: 10.1111/ejh.13379. Epub 2020 Feb 22.
citation: Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10.