CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
bortezomib +1 moredrug
Likely dose
Bortezomib given intravenously (specific dose not stated in protocol)AI-extracted
Key inclusion· 8
  • ✓Newly diagnosed symptomatic multiple myeloma confirmed by serum monoclonal protein ≥1 g/dL, or urine monoclonal light chain ≥200 mg/24 hours, or bone marrow plasmacytosis ≥30%
  • ✓High-risk disease: β2-microglobulin ≥5.5 mcg/mL, PCLI ≥1, or deletion 13 by cytogenetics
  • ✓No prior myeloma-specific therapy except bisphosphonates; radiation of plasmacytoma allowed if ≥4 weeks prior to registration
  • ✓ECOG performance status 0-2; ECOG 3 allowed if secondary to acute bone event (fracture)
Key exclusion· 6
  • ✕Prior peripheral neuropathy >grade 1 (no objective/subjective sensory or motor loss interfering with function)
  • ✕Allergy to boron or mannitol compounds
  • ✕Concurrent chemotherapy, radiotherapy, or biologic therapy (bisphosphonates and chronic corticosteroids for non-myeloma indications allowed)
  • ✕Poorly controlled hypertension

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00075881
NCT00075881Phase 2Completed
CompareCT.gov

Phase II Study of PS-341 for Patients With High-Risk, Newly Diagnosed Multiple Myeloma

National Cancer Institute (NCI)·interventional·Posted Jan 13, 2004·Updated Jun 2, 2014

In Brief

A Phase 2 clinical trial evaluating bortezomib and laboratory biomarker analysis for Stage I Multiple Myeloma and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 2004
Enrollment StartJan 1, 2004
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 22.5 years ago

Interventions

bortezomibdrug

Given IV

laboratory biomarker analysisother

Optional correlative studies