CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 68 enrolled
Drug / intervention
Thalidomide +1 moredrug
Likely dose
Thalidomide 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00432458
NCT00432458Phase 3Completed
CompareCT.gov

A Phase III Randomized Trial of Thalidomide Plus Zoledronic Acid Versus Zoledronic Acid Alone in Patients With Early Stage Multiple Myeloma

Mayo Clinic·interventional·Posted Feb 7, 2007·Updated Jul 4, 2012

In Brief

A Phase 3 clinical trial evaluating Thalidomide and zoledronic acid for Multiple Myeloma and Plasma Cell Neoplasm. Completed, enrolled 68 participants across 4 sites.

Detailed Summary

RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet know whether giving zoledronate together with thalidomide is more effective than zoledronate alone in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying zoledronate and thalidomide see how well they work compared with zoledronate alone in treating patients with early stage multiple myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma and Plasma Cell Neoplasm
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2007
Enrollment StartJul 1, 2003
Primary CompletionJun 1, 2011
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 19.4 years ago

Interventions

Thalidomidedrug

200 mg orally on days 1-28 of 28 day cycle

zoledronic aciddrug

4 mg\^2 by IV on day 1 every 84 days for 1 year and once per year thereafter