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An Open-Label, Randomized Study of VELCADE®-Melphalan-Prednisone versus Melphalan-Prednisone in Subjects With Previously Untreated Multiple MyelomaUnique Dataset IDMultipl_Millenn_2004_146ClinicalTrial.gov IDNCT00111319
Clinical Trial Title
An Open-Label, Randomized Study of VELCADE®-Melphalan-Prednisone versus Melphalan-Prednisone in Subjects With Previously Untreated Multiple Myeloma
Trial Summary and Conditions
Study MMY-3002 was a randomized, open-label, multicenter study to compare the efficacy and safety of Vc-MP therapy against MP therapy in subjects with previously untreated multiple myeloma who were not candidates for HDT/SCT. Subjects were randomly assigned to 1 of 2 treatment groups (Vc-MP or MP) and were stratified according to baseline beta2-microglobulin, baseline albumin levels, and region (North America, Europe, Other). Subjects in the Vc-MP treatment group received VELCADE 1.3 mg/m2 (twice weekly [Weeks 1, 2, 4, and 5] for four 6-week cycles [8 doses per cycle] followed by weekly [Weeks 1, 2, 4, and 5] for five 6-week cycles [4 doses per cycle]) in combination with melphalan 9 mg/m2 and prednisone 60 mg/m2 (once daily on Days 1 to 4 of each 6-week cycle). Subjects in the MP treatment group received 9 cycles of melphalan 9 mg/m2 and prednisone 60 mg/m2 once daily on Days 1 to 4 of each 6-week cycle. For both groups, treatment continued for a maximum of 9 cycles (54 weeks) and was discontinued if progressive disease (PD) or unacceptable treatment-related toxicity occurred, or if a subject withdrew consent. The study consisted of 3 phases: a Pre-randomization (screening) Phase, an Open-label Treatment Phase, and a Post-treatment Follow-up Phase. Throughout the Open-label Treatment and Post-treatment Follow-up Phases, the investigator assessed the subject's response to therapy using the results of efficacy evaluations conducted at equivalent frequency (every 3 weeks in the first 54 weeks and every 8 weeks thereafter) in each treatment group and by applying protocol defined disease-response criteria (EBMT criteria). In the Post-treatment Follow-up Phase, subjects were followed until death or a maximum of 4.5 years after the last subject was randomized on the study.
Control arm data files include raw data on safety, efficacy, demographic, and baseline disease characteristics.
The primary efficacy objective of this study was to determine whether the addition of VELCADE to standard MP therapy improved the time to disease progression (TTP) in subjects with previously untreated multiple myeloma. The secondary objectives of this study were to determine whether the addition of VELCADE to standard MP therapy in subjects with previously untreated multiple myeloma improved the following: progression-free survival (PFS), OS, CR rate, OR rate (CR + PR), time to response, and duration of response. An additional secondary objective was to measure and test global health status as measured by the European Organization for the Research and Treatment of Cancer (EORTC) quality of life (QLQ)-C30, a patient-reported outcome (PRO) instrument. Other objectives included collection of medical resource utilization (MRU) information and use of a preference-based PRO instrument (EQ-5D) to calculate utility values, both of which may be used in future economic evaluation models. Selected measures of clinical benefit were also assessed. The safety of the Vc-MP combination was assessed. Additionally, the effect of melphalan and prednisone on the clinical pharmacokinetics of VELCADE was evaluated.
The primary endpoint of this study was TTP, defined as the interval between the date of randomization and the date of disease progression by computerized algorithm or death due to progression, whichever occurred first. For subjects who were progression free at the time of data cutoff, data were censored for time to progression at the time of their last tumor assessment. For subjects with no post baseline disease assessment, the data were censored on Day 1. The key secondary endpoints of this study were progression free survival, overall survival and response rate. Progression free survival was defined as the interval between the date of randomization and the date of disease progression or death, whichever is earlier. Overall survival was defined as the interval between the date of randomization and the subject's date of death from any cause.Response rate was defined as the proportion of subjects in the response evaluable population who achieved a complete or partial response.
Links to additional datasets associated with this dataset are shown below.
To gain access to the data and analytic tools click here.
CRF: MMY3002PC Annotated CRF.pdf
DATA DICTIONARY: DataDef.xls
DATA (COMPARATOR ARM): Datasets.zip