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Multiple Myeloma

An International, Multi-Center, Randomized, Open-Label Study of PS-341Versus High-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

Unique Data Set IDMultipl_Millenn_2002_147
DownloadableYes
SponsorMillennium Pharmaceuticals, Inc.Data ProviderJanssenTotal Study Enrolled Patients757Comparator (Control) Arm Enrolled Patients336RandomizationYesClinicalTrial.gov IDNCT00048230ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00048230
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeOther

Clinical Trial Title

An International, Multi-Center, Randomized, Open-Label Study of PS-341Versus High-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

Trial Summary and Conditions

This was a multi-center, international, randomized, open-label study designed to determine whether VELCADE provided benefit to patients with relapsed or refractory multiple myeloma relative to treatment with high-dose dexamethasone. This study also was designed to determine the safety and tolerability of VELCADE relative to high-dose dexamethasone. Patients were to be assigned to receive VELCADE or high-dose dexamethasone by random allocation at a 1:1 ratio. Randomization was to be stratified based on 3 factors: the number of lines of prior therapy (one prior line versus more than one prior line of therapy), time of progression relative to last prior therapy (progression while on the most recent therapy or within 6 months of stopping versus relapse >6 months after receiving the most recent therapy) and screening beta2-microglobulin levels (>2.5 mg/L versus <=2.5 mg/L). Patients were to be evaluated at scheduled visits in up to 4 study periods, Pre-Treatment, Treatment, Short-Term Follow-Up, and Long-Term Follow-Up. The Pre-Treatment Period included Screening and Baseline visits. After providing written informed consent to participate in the study, patients were to be evaluated for study eligibility during the Screening period. Eligible patients were to be enrolled in the study and randomly assigned to treatment with VELCADE or dexamethasone via an Interactive Voice Response System (IVRS) system. Day 1 of Cycle 1 was to occur within 72 hours after randomization. All patients who permanently discontinued study drug, whether prematurely or as scheduled were to complete the End of Treatment visit a minimum of 30 days after the last study drug dose. Patients who discontinued study drug for reasons other than confirmed progressive disease (PD) were to continue attending scheduled study center visits on an every 3-week basis until Week 39 or development of confirmed PD, as determined by the (EBMT) criteria.

Data Summary

Control arm data files include raw data on safety, efficacy, demographic, and baseline disease characteristics.

Study Objectives

The primary efficacy objective was to to determine whether VELCADE provided benefit to patients with relapsed or refractory multiple myeloma relative to treatment with high-dose dexamethasone, as assessed by significant prolongation of time to disease progression (TTP) and supported by improvement in selected measures of clinical benefit (development of Grade 3 or worse infections, and development of new skeletal events). Secondary efficacy objectives were to determine whether treatment with VELCADE prolonged survival time (overall and one-year) relative to treatment with high-dose dexamethasone, and to assess the potential superiority of VELCADE to high-dose dexamethasone, as determined by the rates of CR and PR to treatment. An exploratory efficacy objective was to determine whether treatment with VELCADE was associated with a better quality of life (QOL) relative to treatment with high-dose dexamethasone.

Outcome Measures

The primary endpoint of this study was TTP, defined as the interval between the date of randomization and the date of disease progression 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 overall survival and response rate. Overall survival was defined as the interval between the date of randomization and the subject?s date of death from any cause. If the date of death was unknown, the data were censored at the date that the subject was last known to have been alive. Response rate was defined as the proportion of subjects in the response evaluable population who achieved a complete or partial response according to the RECIST criteria provided in the study protocol.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: M34101-039-Protocol.pdf

CRF: MMY_M34101039PC Annotated bankcrf Final.pdf

DATA DICTIONARY: DataDef.xls

DATA (COMPARATOR ARM): Datasets.zip