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
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.
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
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.
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:
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
Hattesburg, Missouri, United States
La Plata - Buenos Aires, Argentina
La Plata - Buenos Aires, Argentina
Porto Alegre, Rio Grande do Sul 90610-00, Brazil
Haidian District Beijing, 100083, China
Athens, 11527, Greece
Athens, 12462, Greece
Rio Patras, 26500, Greece
Debrecen, H-4004, Hungary
Hyderabaad, 500 082, India
Karnataka, 576 104, India
Kerala, India
Kerala, India
Delagacion Tlalpan, 14000, Mexico
Delagacion Tlalpan, 14080, Mexico
Monterrey, Nuevo Leon, 64460, Mexico
Coimbra, 3000-075, Portugal
Lisbon, 1099-023, Portugal
Porto, 4200-072, Portugal
Arghangelsk, 163045, Russia
Saint Petersburg, 191024, Russia
Banska Bysterica, 97517, Slovakia
Groenkloof, Pretoria, 0181, South Africa
Ilmon-Dong, Kangnam-Ku, Seoul, 135-710, South Korea
Ilsandong-Gu, Goyang-Si, and Gyeonggi-Do, 410-769, South Korea
Ilwon Dong, Kangnam-Ku, Seoul, 135-710, South Korea
Donetsk, 83045, Ukraine
Khmelnitsky, 29000, Ukraine
Lviv, 79044, Ukraine