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Trial · NCT01415752

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProgression-free Survival (PFS) for Induction PhaseAssessed at baseline, every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 monthsEligible and treated patients at Step 1 (induction)yearsMEDIAN
PRIMARYProgression-free Survival (PFS) for Maintenance Phase (Step 2)
Assessed at registration to step 2, cycles 6, 12, 18, treatment completion, then every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months
Eligible and treated patients at Step 2 (maintenance)yearsMEDIAN
SECONDARYObjective Response for Induction Phase (Step 1)Assessed at baseline and 24 weeks (end of cycle 6)Eligible and treated patients at Step 1 (induction)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPET-documented Complete Response for Induction Phase (Step 1)Assessed at baseline and 24 weeks (end of cycle 6)
SECONDARYOverall Survival (OS) Rate at 5 Years Since Maintenance (Step 2)Assessed every 3 months for 2.5 years, every 6 months for years 2.5-5Eligible and treated patients for the maintenance phase (Step 2)Proportion of participantsNUMBER
SECONDARYObjective Response for Maintenance (Step 2) Among Patients Without PET-documented CR at the End of InductionAssessed at baseline and every 4 months for 2 years
OTHER_PRE_SPECIFIEDTo Collect Paraffin Embedded Tissue for Creation of Tissue MicroarrayAssessed at baseline
OTHER_PRE_SPECIFIEDTo Collect and Bank Serum and Blood Mononuclear Cells for Future StudiesAssessed at baseline, end of cycle 3, end of cycle 6, every 4 months during first year of maintenance, every 6 months during 2nd year of maintenance, and 12 months after completion of maintenance
OTHER_PRE_SPECIFIEDTo Collect Formalin Fixed Paraffin Embedded (FFPE) Tissue to Analyze Potential Prognostic FactorsAssessed at baseline
OTHER_PRE_SPECIFIEDFunctional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx Subscale) ScoreAssessed at baseline, 6, 12, 30, 36, 48 and 60 months
OTHER_PRE_SPECIFIEDFunctional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale ScoreAssessed at baseline, 6, 12, 30, 36, 48 and 60 months
OTHER_PRE_SPECIFIEDFunctional Assessment of Cancer Therapy - General (FACT-G) ScoreAssessed at baseline, 6, 12, 30, 36, 48 and 60 months
OTHER_PRE_SPECIFIEDTo Evaluate the Effects of Bortezomib-related Neuropathy (FACT/GOG-Ntx Subscale Score) on Patient Reported Health-related Quality of Life (FACT-G Score).Assessed at baseline, 6, 12, 30, 36, 48 and 60 months
OTHER_PRE_SPECIFIEDFunctional Assessment of Cancer Therapy - Lymphoma (FACT-Lymphoma) Subscale ScoreAssessed at baseline, 6, 12, 30, 36, 48 and 60 months
OTHER_PRE_SPECIFIEDTo Evaluate the Response of Lymphoma-specific Symptoms to Treatment.Assessed at baseline, 6, 12, 30, 36, 48 and 60 months
OTHER_PRE_SPECIFIEDThe Trajectory of Overall Health-related Quality of LifeAssessed at baseline, 6, 12, 30, 36, 48 and 60 months
OTHER_PRE_SPECIFIEDTo Assess the Proportion of Patients up and Down Staging When FDGPET/CT is Added to Standard Ann Arbor Staging.Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years
OTHER_PRE_SPECIFIEDTo Assess the Ability of Pre-treatment FDG-PET/CT Semi Quantitative Parameters Including SUVmax and Metabolic Measurements to Predict Response Rate and PFS.Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years
OTHER_PRE_SPECIFIEDAssessment of the Correlation of Interim FDG-PET/CT Imaging With Response Rate and PFS Both During Induction and Consolidation TherapyAssessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years
OTHER_PRE_SPECIFIEDTo Assess Standard FDG-PET/CT Metrics and Association With Pathology FeaturesAssessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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