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LYM-3001: 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 LymphomaUnique Dataset IDLymphom_Millenn_2006_170ClinicalTrial.gov IDNCT00312845
Clinical Trial Title
LYM-3001: 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 Lymphoma
Trial Summary and Conditions
Study LYM-3001 was a multi-center, international, randomized, open-label study designed to determine whether VELCADE with rituximab provided benefit to patients with relapsed or refractory, rituximab-naive or -sensitive follicular B-cell Non- Hodgkin's Lymphoma (B-NHL) relative to treatment with rituximab alone. The study was had an open-label treatment phase consisting of up to 5 cycles of treatment (5 weeks duration for each cycle, up to 25 weeks total treatment duration) and a posttreatment phase. Throughout the open-label treatment phase, the investigator assessed subject response to therapy using efficacy measurements and disease response criteria. Dose modifications were made as required according to dose-modification rules. During the posttreatment phase, subjects were followed for disease progression, initiation of subsequent therapy for NHL, and survival until the end of the study, which was expected to be 20 months after the last subject was randomized on study. Subjects were stratified based on: Follicular Lymphoma International Prognostic Index (FLIPI) score (low [0-1 factor] vs intermediate [2 factors] vs high [>=3 factors]), prior rituximab therapy (yes vs no), time since last dose of anti-lymphoma therapy (<=1 vs >1 year), and region (US vs EU vs Rest of World). Subjects were randomized to Treatment Arms A or B in a 1:1 ratio as follows: - Treatment Arm A (test arm): 1.6 mg/m2 VELCADE for Injection was administered by IV bolus weekly on Days 1, 8, 15, and 22 of a 35-day cycle, followed by single bolus of 375 mg/m2 rituximab on Day 1 of Cycles 2 to 5. Subjects also received rituximab as per Treatment Arm B. - Treatment Arm B (control arm): 375 mg/m2 rituximab once a week on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m2 on Day 1 of Cycles 2 to 5 (for a total of 8 doses).
Control arm data files include raw data on safety, efficacy, demographic, and baseline disease characteristics.
The primary objective of this study was to determine whether VELCADE with rituximab provided benefit to subjects with relapsed or refractory, rituximab-naive or -sensitive follicular B-cell Non- Hodgkin's Lymphoma (B-NHL) relative to treatment with rituximab alone, as assessed by prolongation of progression-free survival (PFS). Secondary efficacy objectives were to determine the: ORR (complete response [CR] + CR unconfirmed [CRu] + partial response [PR]) to VELCADE in combination with rituximab according to modified criteria developed by the International Workshop to Standardize Response Criteria for NHL (IWRC); overall CR rate (CR + CRu); duration of response; time to progression (TTP); overall survival (OS) rate; one-year survival rate The safety objective was to evaluate the safety and tolerability of VELCADE in combination with rituximab. An exploratory efficacy objective was to measure and test global health status via use of the EORTC QLQ-C30.
The primary endpoint of this study was PFS, defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever was first reported in the intent-to-treat (ITT) population. Subjects who withdrew from the study (i.e., withdrawal of consent, lost to follow-up) or change therapy without documented progression were censored at the time of the last adequate disease assessment. Subjects who completed the study, did not progress, and were still alive at the cut-off date of the final analysis were censored at the last adequate disease assessment. Secondary efficacy endpoints included: ORR, CR rate, duration of response (CR, CRu, or PR), TTP, OS, and 1-year survival rate.
To gain access to the data and analytic tools click here.
PROTOCOL: Millenium_LYM-3001 Protocol.pdf
DATA DICTIONARY: LYM-3001_Dictionary.pdf
DATA (COMPARATOR ARM): PS341_LYM3001_xpt.zip