Multiple Myeloma Clinical Trial
A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)
Summary
The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.
Full Description
The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow progressive disease (PD) and improve overall survival in people who have NDMM who have had a major positive response to initial therapy and have not undergone SCT. This study will look at the effect of ixazomib citrate has on the length of time that participants are free of PD and their overall survival.
The study will enrol approximately 700 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 3:2 ratio to Ixazomib or matching placebo groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
Ixazomib citrate initiates at 3 mg which will be escalated to 4 mg with cycle 5 day 1
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. The treatment period will be approximately 24 months (equivalent to 26 cycles) or until patients experience PD or unacceptable toxicities, whichever occurs first.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 78 to 106 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make follow-up visits every 4 weeks until the next line of therapy begins. Participants will also be contacted by telephone every 12 weeks after last treatment visit for a follow-up assessment.
Eligibility Criteria
Inclusion Criteria:
Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.
Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.
Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.
Female participants who:
Are postmenopausal for at least 1 year before the screening visit, OR
Are surgically sterile, OR
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, 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] and withdrawal are not acceptable methods of contraception.)
Male participants, even if surgically sterilized (that is, 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, OR
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
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.
Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
Eastern Cooperative Oncology Group Performance Status of 0 to 2.
Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.
Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.
Must meet the following clinical laboratory criteria at study entry:
Absolute neutrophil count (ANC) greater than or equal to (≥) 1,000 per cubic millimeter (/mm^3) without growth factor support 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 less than or equal to (≤) 1.5*the upper limit of the normal range (ULN).
Alanine aminotransferase and aspartate aminotransferase ≤ 3*ULN.
Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min) (using the Cockcroft-Gault equation).
Exclusion Criteria:
Multiple myeloma that has relapsed after, or was not responsive to, initial therapy.
Prior SCT.
Radiotherapy within 14 days before randomization.
Diagnosed or treated for another malignancy within 5 years before randomization or previous diagnosis with another malignancy. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
Major surgery within 14 days before randomization.
Central nervous system involvement.
Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.
Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or St. John's wort within 14 days before randomization.
Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection.
Comorbid systemic illnesses or other severe concurrent disease that, 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 (example, PN that is Grade 1 with pain or Grade 2 or higher of any cause).
Psychiatric illness or social situation that would limit compliance with study requirements.
Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
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.
Treatment with any investigational products within 30 days before randomization.
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There are 255 Locations for this study
Fountain Valley California, 92708, United States
Los Angeles California, 90095, United States
Oceanside California, 92056, United States
Oxnard California, 93030, United States
Redlands California, 92373, United States
San Jose California, 95124, United States
Santa Maria California, 93454, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60612, United States
Sioux City Iowa, 51101, United States
Hazard Kentucky, 41701, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21229, United States
Bethesda Maryland, 20817, United States
Boston Massachusetts, 02111, United States
Lansing Michigan, 48912, United States
New York New York, 10021, United States
New York New York, 10021, United States
Asheville North Carolina, 28801, United States
Pittsburgh Pennsylvania, 15232, United States
Tyler Texas, 75701, United States
Seattle Washington, 98109, United States
Morgantown West Virginia, 26506, United States
Buenos Aires Ciudad Autonoma De BuenosAires, B1629, Argentina
Buenos Aires Ciudad Autonoma De BuenosAires, C1181, Argentina
Buenos Aires Ciudad Autonoma De BuenosAires, C1431, Argentina
Cordoba , X5000, Argentina
Santa Fe , S3000, Argentina
Fitzroy Victoria, 3065, Australia
Frankston Victoria, 3199, Australia
Melbourne Victoria, 3004, Australia
Innsbruck Tirol, 6020, Austria
Salzburg , 5020, Austria
Wels , 4600, Austria
Wien , A-109, Austria
Brussel Brussels, 1090, Belgium
Brussel Brussels, 1090, Belgium
Bruxelles Brussels, 1200, Belgium
Salvador Bahia, 41253, Brazil
Goiania Goias, 74605, Brazil
Belo Horizonte Minas Gerais, 30130, Brazil
Curitiba Parana, 81520, Brazil
Natal Rio Grande Do Norte, 59040, Brazil
Caxias Do Sul Rio Grande Do Sul, 95070, Brazil
Ijui Rio Grande Do Sul, 98700, Brazil
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90470, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Joinville Santa Catarina, 89201, Brazil
Barretos Sao Paulo, 14784, Brazil
Campinas Sao Paulo, 13083, Brazil
Jau Sao Paulo, 17210, Brazil
Santo Andre Sao Paulo, 09060, Brazil
Rio De Janeiro , 20211, Brazil
Rio de Janeiro , 20231, Brazil
Rio De Janeiro , 21941, Brazil
Sao Jose Do Rio Preto , 15090, Brazil
Sao Paulo , 01236, Brazil
Sao Paulo , 01308, Brazil
Sao Paulo , 01509, Brazil
Sao Paulo , 04537, Brazil
Sao Paulo , 05403, Brazil
Sao Paulo , 05652, Brazil
Sao Paulo , 08270, Brazil
Barrie Ontario, L4M 6, Canada
Brampton Ontario, L6W 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4A 3, Canada
Temuco Araucanía, 48008, Chile
Santiago , 83804, Chile
Santiago , , Chile
Vina Del Mar , 25700, Chile
Nanjing Jiangsu, 21002, China
Shanghai Shanghai, 20002, China
Hangzhou Zhejiang, 31000, China
Beijing , 10002, China
Beijing , 10019, China
Beijing , , China
Hangzhou , 31000, China
Shanghai , 20000, China
Shanghai , 20000, China
Shenyang , 11000, China
Taiyuan , 03000, China
Wuhan , 43003, China
Medellin Antioquia, 05003, Colombia
Bogota Cundinamarca, , Colombia
Bogota Distrito Capital De Bogota, 11031, Colombia
Zagreb Grad Zagreb, 10000, Croatia
Rijeka , 51000, Croatia
Zagreb , 10 00, Croatia
Hradec Kralove Kralovehradeck Kraj, 500 0, Czechia
Prague Praha, Hlavni Mesto, 100 3, Czechia
Brno , 625 0, Czechia
Olomouc , 775 2, Czechia
Ostrava , 708 5, Czechia
Praha 2 , 128 0, Czechia
København Capital, 2100, Denmark
Aarhus N , DK-82, Denmark
Holstebro , 7500, Denmark
Odense , 5000, Denmark
Clamart Hauts-de-Seine, 92140, France
Nantes Loire-Atlantique, 44093, France
Vandoeuvre-les-nancy Meurthe-et-Moselle, 54511, France
Dijon , 21079, France
Lille , 59020, France
Lille , 59037, France
Paris , 75013, France
Paris , 75015, France
Pessac , 33604, France
Poitiers , 86021, France
Rennes , , France
Ulm Baden-Wurttemberg, 89081, Germany
Villingen-Schwenningen Baden-Wurttemberg, 78050, Germany
Augsburg Bayern, 86150, Germany
Herrsching am Ammersee Bayern, 82211, Germany
Munchen Bayern, 81377, Germany
Oldenburg Niedersachsen, 26121, Germany
Essen Nordrhein-Westfalen, 45122, Germany
Munster Nordrhein-Westfalen, 48149, Germany
Mainz Rheinland-Pfalz, 55131, Germany
Homburg Saarland, 66421, Germany
Aschaffenburg , 63739, Germany
Berlin , 12200, Germany
Berlin , 14195, Germany
Landshut , 84034, Germany
Munchen , 81675, Germany
Rosenheim , 83022, Germany
Wurzburg , 97080, Germany
Athens Attiki, 115 2, Greece
Athens , 10676, Greece
Ioannina , 45500, Greece
Larissa , 41110, Greece
Thessaloniki , 54007, Greece
Thessaloniki , 57010, Greece
Budapest , 1083, Hungary
Budapest , 1097, Hungary
Debrecen , 4032, Hungary
Szeged , 6725, Hungary
Be'er Sheva , 84101, Israel
Beer Yaakov , 70300, Israel
Haifa , 33394, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Tel Aviv , 69710, Israel
Tiberias , 15208, Israel
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Rimini Emilia-Romagna, 47900, Italy
Genova Liguria, 16132, Italy
Brescia Lombardia, 25123, Italy
Milano Lombardia, 20162, Italy
San Giovanni Rotondo Puglia, 71013, Italy
Catania Sicilia, 95124, Italy
Pisa Toscana, 56216, Italy
Terni Umbria, 05100, Italy
Ancona , 60126, Italy
Firenze , 50139, Italy
Parma , 43126, Italy
Ravenna , 48100, Italy
Torino , 10126, Italy
Ogaki Gihu, 503-8, Japan
Kobe-City Hyogo, 650-0, Japan
Hitachi Ibaraki, 317-0, Japan
Ikoma-City Nara, 630-0, Japan
Okayama-city Okayama, 701-1, Japan
Bunkyo Tokyo, 113-8, Japan
Shibuya-ku Tokyo, 150-8, Japan
Fukuoka , 810-8, Japan
Fukushima-City , 960-1, Japan
Ibaraki , 311-3, Japan
Kurume , 830-0, Japan
Nagaizumi-chō , 41187, Japan
Nagoya , 453-8, Japan
Nagoya , 467-8, Japan
Narita-shi , 286-8, Japan
Niigata-city , , Japan
Osaka , 530-0, Japan
Tachikawa , 19000, Japan
Toyohashi , , Japan
Yamanashi , 400-8, Japan
Goyang-si Gyeonggido, 10408, Korea, Republic of
Incheon , 405-7, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 137-7, Korea, Republic of
Guadalajara Jalisco, 44160, Mexico
Monterrey Nuevo Leon, 64000, Mexico
Monterrey Nuevo Leon, 64460, Mexico
Mexico City , 14000, Mexico
Oaxaca , 68000, Mexico
Bydgoszcz Kujawsko-pomorskie, 85-16, Poland
Warszawa Mazowieckie, 02-10, Poland
Chorzow , , Poland
Wroclaw , 50-36, Poland
Lisbon Lisboa, 1099-, Portugal
Almada , 2801-, Portugal
Braga , 4710-, Portugal
Lisboa , 1400-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Porto , 4200-, Portugal
Kirov , 61002, Russian Federation
Pyatigorsk , 35750, Russian Federation
Ryazan , 39003, Russian Federation
St. Petersburg , 19302, Russian Federation
St. Petersburg , 19711, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11080, Serbia
Kragujevac , 34000, Serbia
Nis , 18000, Serbia
Singapore , 11907, Singapore
Singapore , 16960, Singapore
Johannesburg Gauteng, 2196, South Africa
Pretoria Gauteng, 0044, South Africa
Pretoria Gauteng, 0181, South Africa
Badalona Barcelona, 08916, Spain
Pozuelo De Alarcon Madrid, Communidad Delaware, 28223, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Madrid , 28006, Spain
Madrid , 28009, Spain
Madrid , 28031, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Murcia , 30008, Spain
Salamanca , 37007, Spain
Valencia , 46026, Spain
Stockholm Sodermanlands Lan, , Sweden
Stockholm Sodermanlands Lan, , Sweden
Goteborg Vastra Gotalands Lan, , Sweden
Lund , SE-22, Sweden
Thun , CH-36, Switzerland
Kaohsiung , 807, Taiwan
Taichung , 40705, Taiwan
Taipei , 100, Taiwan
Bangkok Krung Thep Maha Nakhon, 10400, Thailand
Bangkok , 10330, Thailand
Chiangmai , 50200, Thailand
Ankara , 06100, Turkey
Ankara , 06590, Turkey
Istanbul , 34093, Turkey
Izmir , 35340, Turkey
Belfast Antrim, BT9 7, United Kingdom
West Malling Birmingham, B9 5S, United Kingdom
Bristol Bristol, City Of, BS2 8, United Kingdom
Bournemouth Dorset, BH7 7, United Kingdom
Portsmouth Hampshire, PO6 3, United Kingdom
Canterbury Kent, CT1 3, United Kingdom
London London, City Of, EC1A , United Kingdom
London London, City Of, NW1 2, United Kingdom
London London, City Of, SE5 9, United Kingdom
London London, City Of, W12 0, United Kingdom
Uxbridge London, City Of, UB8 3, United Kingdom
Oxford Oxfordshire, OX3 7, United Kingdom
Wolverhampton Staffordshire, WV10 , United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Bath , BA1 3, United Kingdom
Belfast , BT16 , United Kingdom
Bristol , BS10 , United Kingdom
Cardiff , CF14 , United Kingdom
Isleworth , TW7 6, United Kingdom
Leicester , LE1 5, United Kingdom
London , , United Kingdom
Manchester , M13 9, United Kingdom
Middlesex , HA1 3, United Kingdom
Oldham , OL1 2, United Kingdom
Southall , UB1 3, United Kingdom
Swansea , , United Kingdom
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