Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma

The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.

Study Overview

• Status: Completed
• Conditions: Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: Bortezomib + Rituximab; Drug: Rituximab

• Study Type: Interventional
• Enrollment (Actual): 676
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • La Plata - Buenos Aires, Argentina
    • Higa San Martin
  • La Plata - Buenos Aires, Argentina
    • Hospital Professor Rodolfo Rossi
  • Mendoza, Argentina
    • Centro Oncologico Integracion Regional
• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Peter Maccallum Cancer Institute
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Hospital
• Belgium
  • Anderlecht, Belgium, 1070
    • ULB Erasme
  • Antwerpen, Belgium, 2060
    • AZ Stuivenberg
  • Brugge, Belgium, 8000
    • AZ Sint Jan
  • Bruxelles, Belgium, 1000
    • Institute J. Bordet
  • Charleroi, Belgium, 6000
    • Clinique Notre Dame
  • Edegem, Belgium, 2650
    • UZ Antwerpen - Universitair Ziekenhuis Antwerpen
  • Gent, Belgium, 9000
    • UZ Gent - Universitair Ziekenhuis Gent
  • Hasselt, Belgium, 3500
    • Virga Jesse Ziekenhuis, Dienst Hematologie
  • Liege, Belgium, 4000
    • Chu Sart Tilman
  • Liege, Belgium, 4000
    • CHR La Citadelle
  • Roeselare, Belgium, 8800
    • Heilig Hart Roeselare
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Câncer
  • Sao Paulo, Brazil, 01404-901
    • Hospital Brigadeiro
  • Sao Paulo, Brazil, 09060-650
    • Faculdade de Medicina do ABC
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-00
      • Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul
• Canada
  • Hamilton, Canada
    • Juravinski Cancer Centre
  • Ontario
    • Toronto, Ontario, Canada
      • Toronto Sunnybrook Regional Cancer Centre
    • Toronto, Ontario, Canada
      • University Health Network - Princess Margaret Hospital
• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 100036
    • Beijing Cancer Hospital
  • Beijing, China, 100021
    • Cancer Hospital (Institute), CAMS&PUMC
  • Beijing, China, 100071
    • Affiliated Hospital of the Academy of Military Medical Sciences
  • Guangzhou, China, 510060
    • Cancer Center, Sun Yat-sen University
  • Haidian District Beijing, China, 100083
    • Peking University Third Hospital
  • Shanghai, China, 200025
    • Ruijin Hospital
  • Shanghai, China, 200032
    • Cancer Hospital - FuDan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan
• Cyprus
  • Nikosia, Cyprus, 2006
    • Bank Of Cyprus Oncology Centre
• Czech Republic
  • Brno, Czech Republic, 625 00
    • Fakultni nemocnice Brno
  • Hradec Kralove, Czech Republic, 500 05
    • Fakultni Nemocnice Hradec Kralove
  • Olomouc, Czech Republic, 775 20
    • Fakultni nemocnice Olomouc
  • Praha, Czech Republic, 2
    • Vseobecna Fakultni Nemocnice
• Finland
  • Lahti, Finland, 15850
    • Paijat - Hameen Keskussairaala
  • Pori, Finland, 28500
    • Satakunnan Keskussairaala
• France
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Le Mans, France, 72015
    • Clinique Victor Hugo
  • Lille, France, 59037
    • Hopital Claude Huriez
  • Lyon, France, 69373
    • Centre léon bérard
  • Nantes, France, 44098
    • Hôpital Hôtel Dieu
  • Pessac, France, 33604
    • Service des Maladies due sang - Hopital haut Leveque
  • Pierre Benite, France, 69495
    • Centre Hospitalier Lyon Sud
• Germany
  • Herrsching, Germany, 82211
    • Onkologische Schwerpunktpraxis
  • Munster, Germany
    • Universitatsklinikum Munster - Klinik fur Innere Medizin
  • Würzburg, Germany, 97070
    • Praxis für Hämetologie und Oncologie
• Greece
  • Athens, Greece, 11527
    • Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department
  • Athens, Greece, 12462
    • University General Hospital Attikon - 2nd Department of Internal Medicine - Propedeutic & Research Institute
  • Rio Patras, Greece, 26500
    • University Hospital of Patras - Department of Internal Medicine - Hematology Division
• Hungary
  • Debrecen, Hungary, H-4004
    • Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika
  • Gyor, Hungary, 9024
    • Petz Aladar County Hospital
  • Szeged, Hungary, H-6720
    • SZEgedi Tudomanyegyetem, II Belgyaszati Klinika
• India
  • Bangalore, India
    • Institution Manipal Hospital
  • Chandigarh, India, 160 012
    • Postgraduate Institute of Medical Education and Research
  • Chennai, India, 6000035
    • Apollo Speciality Hospital
  • Hyderabaad, India, 500 082
    • Nizam's Institute of Medical Sciences
  • Jaipur, India, 302 004
    • SMS Medical College Hospital
  • Jubilee Hills, India
    • Apollo Hospitals, Hyderabad Apollo Hospital Complex
  • Karnataka, India, 576 104
    • Shirdi Saibaba Cancer Hospital
  • Kerala, India
    • Department of Medical Oncology - Regional Cancer Centre
  • Kerala, India
    • Regional Cancer Centre
  • Mumbai, India, 400 012
    • Tata Memorial Centre
• Israel
  • Beer Sheva, Israel
    • Soroka Medical Center
  • Haifa, Israel
    • Rambam Medical Center
  • Jerusalem, Israel
    • Hadassah Medical Center
  • Petah Tikva, Israel
    • Rabin Medical Center
  • Tel Aviv, Israel
    • Sorraski Tel Aviv Medical Center
  • Tel HaShomer, Israel
    • Sheba Medical Center
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliero Universitaria di Bologna
  • Perugia, Italy, 06122
    • Università degli Studi di Perugia
  • Roma, Italy, 00133
    • Azienda Ospedallera Universitaria Policlinico Tor Vergata
  • Torino, Italy, 10126
    • Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
• Korea, Republic of
  • Gyeonggi-Do, Korea, Republic of, 411-769
    • Lung Cancer Center - National Cancer Center
  • Ilmon-Dong, Kangnam-Ku, Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine
  • Ilsandong-Gu, Goyang-Si, and Gyeonggi-Do, Korea, Republic of, 410-769
    • Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center
  • Ilwon dong, Kangnam-Ku, Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center - Department of Internal Medicine
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 120-752
    • Severance hospital, Yonsei university college of medicine
• Mexico
  • Delagacion Tlalpan, Mexico, 14000
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Delagacion Tlalpan, Mexico, 14080
    • Instituto Nacional De Cancerologia Incan
  • Monterrey, Nuevo leon, Mexico, 64460
    • Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL
• New Zealand
  • Christchurch, New Zealand
    • Canterbury Health Laboratories
• Poland
  • Gdansk, Poland, 80-952
    • Klinika Hematologii Instytut Chorob Wewnetrznych
  • Krakow, Poland, 31-501
    • Klinika Hematologii CMUJ
  • Lodz, Poland, 93-510
    • Klinika Hematologii - Uniwersytetu Medycznego
  • Lublin, Poland, 20-081
    • Klinika Hematologii i Transplantologii Szpiku AM
  • Warsawa, Poland, 00-909
    • Wojskowy Instytut Medyczny - Klinika Hematologii
  • Warszawa, Poland, 00-957
    • Instytut Hematologii i Transfuzjologii
  • Warszawa, Poland, 02-097
    • Klinika Hematologii AM
  • Warszawa, Poland, 02-781
    • Klinika Nowotworow Ukladu Chlonnego
  • Wroclaw, Poland, 50-367
    • Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
• Portugal
  • Coimbra, Portugal, 3000-075
    • Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra
  • Lisboa, Portugal, 1099-023
    • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia
  • Lisboa, Portugal, 1649-035
    • Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E.
  • Porto, Portugal, 4200-072
    • Serviço de Onco-hematologia, Instituto Português de Oncologia do Porto Franscisco Gentil, EPE
• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • San Juan VA Medical Center
• Romania
  • Brasov, Romania
    • Spitalul clinic de urgenta
  • Bucuresti, Romania
    • Institutul Clinic Fundeni Clinica de Hematologie
  • Bucuresti, Romania
    • Spitalul Universitar de Urgenta Hematologie
  • Iasi, Romania
    • Spitalul Clinic judetean de urgenta "Sf. Spiridon, Clinica Hematologie
  • Targu Mures, Romania
    • Spitalul Clinic Judetean de Urgenta Mures
• Russian Federation
  • Arghangelsk, Russian Federation, 163045
    • Arkhangelsk Region Clinical Hospital
  • Barnaul, Russian Federation, 656049
    • Altay Regional Oncology Dispensary
  • Belgorod, Russian Federation, 308010
    • Belgorod Regional Oncology Center
  • Cheliabinsk, Russian Federation, 454087
    • Cheliabinsk Regional Oncology Dispensary
  • Ekaterinburg, Russian Federation, 620137
    • Ekaterinburg City Clinical Hospital #7
  • Izhevsk, Russian Federation, 426039
    • 1st Republican Clinical Hospital of Udmurtia
  • Moscow, Russian Federation, 143423
    • City Oncology Hospital #62
  • Moscow, Russian Federation, 115478
    • Cancer Research Center
  • Moscow, Russian Federation, 125101
    • S.P. Botkin Moscow City Clinical Hospital
  • Moscow, Russian Federation, 129110
    • Moscow Region Clinical Research Institute
  • Moscow, Russian Federation, 129128
    • Semashko Central Clinical Hospital #2
  • Nizhniy Novgorod, Russian Federation, 603129
    • Nizhniy Novgorod Region Clinical Hospital
  • Novosibirsk, Russian Federation, 630087
    • Novosibirsk State Regional Clinical Hospital
  • Novosibirsk, Russian Federation, 630091
    • Novosibirsk State Medical University
  • Obninsk, Russian Federation, 249020
    • Medical Scientifical Radiology Center
  • Petrozavodsk, Russian Federation, 185019
    • Republikan Hospital named after V.A. Baranov
  • Saint Petersburg, Russian Federation, 197022
    • Saint Petersburg Pavlov State Medical University
  • Saratov, Russian Federation, 410028
    • Saratov State Medical University
  • St. Petersburg, Russian Federation, 191024
    • St. Petersburg Clinical Research Institute of Hematology and Transfusiology
  • St. Petersburg, Russian Federation, 197110
    • St. Petersburg City Hospital #31
  • Tomsk, Russian Federation, 634028
    • Tomsk Research Oncology Institute
  • Ufa, Russian Federation, 450005
    • Republican Clinical Hospital of Bashkorkostan
• Slovakia
  • Banska Bysterica, Slovakia, 97517
    • FN F.D. Roosevelt - Oddelenie hematologie
  • Kosice, Slovakia, 040 11
    • Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie
  • Kosice, Slovakia, 041 90
    • Vychodoslovensky Onkologicky Ustave, a.s.
  • Martin, Slovakia, 036 59
    • Martinska FN, Klinika hematologie a transfuziologie
• South Africa
  • Groenkloof, Pretoria, South Africa, 0181
    • Mary Potter Oncology Centre - Little Company of Mary Hospital
  • Johannesburg, South Africa
    • Chris Hani Baragwanath Hospital
  • Port Elizabeth, South Africa
    • East Cape Oncology Centre - St. Georges Hospital
  • Cape Town
    • Panorama, Cape Town, South Africa
      • GVI Oncology Clinical Trial Unit
• Spain
  • Barcelona, Spain, 08907
    • Hospital Durans I Reynals - Institut Catala d'Oncologia
  • Barcelona, Spain, 08916
    • Hospital Germans Trias i Pujol Institut Catala d'Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
• Sweden
  • Lund, Sweden
    • Onkologiska kliniken Universitetssjukhuset
  • Stockholm, Sweden
    • Centrum for Hematologi Karolinska University Hospital
  • Stockholm, Sweden
    • Hematologiska kliniken M54 Karolinska University Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Mahidol University
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital, Mahidol University
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
• Ukraine
  • Cherkassy, Ukraine, 18009
    • Cherkassy Regional Oncology Dispensary
  • Dnepropetrovsk, Ukraine, 46055
    • Dnepropetrovsk Regional Clinical Oncology Dispensary
  • Donetsk, Ukraine, 83045
    • Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine
  • Khmelnitsky, Ukraine, 29000
    • Khmelnitskiy Regional Hopsital
  • Kiev, Ukraine, 03115
    • Kiev Center of Marrow Transplantaion
  • Krivoy Rog, Ukraine
    • Krivoy Rog Oncology Dispensary
  • Lviv, Ukraine, 79044
    • Institute of Blood Pathology and Transfusional Medicine of AMS of Ukraine, Lviv Clinical Hospital #5
  • Poltava, Ukraine, 36024
    • Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary
  • Simferopol, Ukraine
    • Crimean Republic Clinical Oncology Dispensary
  • Zhitomir, Ukraine, 10002
    • Zhitomir Gerbachevsky Regional Clinical Hospital
• United Kingdom
  • Aberdeen, United Kingdom
    • Aberdeen Royal Infirmary - Department of Haematology
  • Cambridge, United Kingdom, CB2 2QQ
    • Addenbrooke's Hospital - Department of Haematology
  • Cardiff, United Kingdom, CF14 4XN
    • University Hospital of Wales
  • London, United Kingdom, SE1 9RT
    • Guy's & St. Thomas Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital - Department of Haematology
  • Taunton, United Kingdom, TA1 5DA
    • Taunton & Somerset Hospital
• United States
  • Alabama
    • Opelika,, Alabama, United States
      • East Alabama Medical Center
  • California
    • Alhambra, California, United States, 91801
      • Central Hematology Oncology Medical Group, Inc
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood and Cancer Center
    • Burbank, California, United States, 91505
      • Providence Saint Joseph Medical Center
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Medical Group
    • La Verne, California, United States, 91790
      • Wilshire Oncology Medical Group, Inc.
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
    • Mission Hills, California, United States, 91345
      • North Valley Hematology Oncology
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center
    • Oxnard, California, United States, 93030
      • Ventura County Hematology-Oncology Specialists
    • Redondo Beach, California, United States, 90277
      • Cancer Care Associates Medical Group, Inc.
    • Santa Maria, California, United States, 93454
      • Central Coast Medical Oncology Corporation
  • Connecticut
    • Norwalk, Connecticut, United States
      • Norwalk Medical Group
    • Stamford, Connecticut, United States
      • Hematology Oncology PC
  • Florida
    • Jacksonville, Florida, United States
      • Integrated Community Oncology Network
    • Miami, Florida, United States
      • Innovative Clinical Research of South Florida
    • West Palm Beach, Florida, United States
      • Palm Beach Cancer Institute
  • Georgia
    • Atlanta, Georgia, United States
      • Emory Univeersity ,Winship Cancer Institute
    • Lawrenceville, Georgia, United States, 30045
      • Suburban Hematology-Oncology Associates
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, P.C.
  • Idaho
    • Coeur D Alene, Idaho, United States
      • North Idaho Cancer Center
  • Indiana
    • Indianapolis, Indiana, United States
      • Investigative Clinical Research of Indiana
  • Iowa
    • Sioux City, Iowa, United States
      • Siouxland Hematolgoy-Oncology Associates
  • Kansas
    • Kansas City, Kansas, United States, 66210
      • Kansas City Cancer Center, LLC
  • Kentucky
    • Louisville, Kentucky, United States
      • Louisville Oncology
  • Louisiana
    • Metairie, Louisiana, United States
      • Hematology & Oncology Specialists
  • Maryland
    • Baltimore, Maryland, United States
      • Sinai Hospital
  • Missouri
    • Hattesburg, Missouri, United States
      • Hattiesburg Clinic
  • North Carolina
    • Goldsboro, North Carolina, United States, 27530
      • Southeastern Medical Oncology Center
  • Oregon
    • Portland, Oregon, United States
      • Oregon Health & Science University
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Lancaster Cancer Center, Ltd.
    • Pittsburg, Pennsylvania, United States
      • The Western Pennsylvania Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29210
      • South Carolina Oncology Associates, PA
    • Columbia, South Carolina, United States
      • South Carolina Oncology Associates
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Texas
    • Fort Worth, Texas, United States
      • The Center for Cancer and Blood Disorders
    • Houston, Texas, United States, 777024
      • Oncology Consultants
    • San Antonio, Texas, United States
      • South Texas Oncology And Hematology
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Medical College of Wisconsin Milwaukee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

• Man or woman and age 18 years or older
• Diagnosis of follicular B-NHL of the following subtypes (World Health Organization [WHO] classification 1997): follicular lymphoma (FL) (Grades 1 and 2).
• Documented relapse or progression following prior antineoplastic treatment. New lesions or objective evidence of progression of existing lesions must document relapse or progression following the previous therapy.

If any prior regimen included rituximab, the subject must have responded (complete response [CR], unconfirmed complete response [CRu], partial response [PR]), and the time to progression (TTP) from the first dose of rituximab must have been 6 months or more.

• At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and greater than 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation
• In the opinion of the investigator the decision to initiate treatment is justified to manage the subject's lymphoma
• No active central nervous system lymphoma
• Eastern Cooperative Oncology Group [ECOG] status ≤ 2
• Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening.
• Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• In countries where health authorities have approved the pharmacogenomic testing, subjects or their legally acceptable representatives must have signed a separate informed consent that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for pharmacogenomics testing, but optional for serum protein testing and future testing.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

• Diagnosed or treated for a malignancy other than NHL within 1 year of randomization, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.
• Clinical evidence of a transformation from indolent NHL to a more aggressive form of NHL.

• History of disallowed therapies:

  • Prior treatment with VELCADE
  • Antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
  • Nitrosoureas within 6 weeks before randomization
  • Radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
  • Stem cell transplant within 6 months before randomization
  • Major surgery within 2 weeks before randomization
• Residual toxic effects of previous therapy or surgery of Grade 3 or worse
• Peripheral neuropathy or neuropathic pain of Grade 2 or worse
• Have received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
• History of allergic reaction attributable to compounds containing boron or mannitol
• Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate
• Concurrent treatment with another investigational agent
• Female subject who is pregnant or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rituximab	Drug: Rituximab; rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).
Experimental: Bortezomib + Rituximab	Drug: Bortezomib + Rituximab; VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.	Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate	Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.	Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.

Collaborators and Investigators

• Sponsor: Millennium Pharmaceuticals, Inc.
• Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

General Publications

• Zinzani PL, Khuageva NK, Wang H, Garicochea B, Walewski J, Van Hoof A, Soubeyran P, Caballero D, Buckstein R, Esseltine DL, Theocharous P, Enny C, Zhu E, Elsayed YA, Coiffier B. Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-naive or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial. J Hematol Oncol. 2012 Oct 22;5:67. doi: 10.1186/1756-8722-5-67.
• Coiffier B, Osmanov EA, Hong X, Scheliga A, Mayer J, Offner F, Rule S, Teixeira A, Walewski J, de Vos S, Crump M, Shpilberg O, Esseltine DL, Zhu E, Enny C, Theocharous P, van de Velde H, Elsayed YA, Zinzani PL; LYM-3001 study investigators. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial. Lancet Oncol. 2011 Aug;12(8):773-84. doi: 10.1016/S1470-2045(11)70150-4. Epub 2011 Jul 1.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: April 7, 2006
• First Submitted That Met QC Criteria: April 7, 2006
• First Posted (Estimate): April 11, 2006

Study Record Updates

• Last Update Posted (Estimate): June 25, 2012
• Last Update Submitted That Met QC Criteria: June 19, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: B-cell Non-Hodgkin's Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab; Bortezomib
• Other Study ID Numbers: 26866138-LYM-3001