CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 96 enrolled
Drug / intervention
Dexamethasone +2 moredrug
Likely dose
Dexamethasone 20, unitfrom 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/NCT00813150
NCT00813150Phase 3Completed
CompareCT.gov

Randomized Phase III Study on Bortezomib and Low-Dose Dexamethasone With or Without Continuous Low-Dose Oral Cyclophosphamide for Primary Refractory or Relapsed Multiple Myeloma

Janssen-Cilag G.m.b.H·interventional·Posted Dec 22, 2008·Updated Aug 15, 2014

In Brief

A Phase 3 clinical trial evaluating Dexamethasone, Bortezomib, and 1 other intervention for Multiple Myeloma. Completed, enrolled 96 participants across 40 sites.

Detailed Summary

The purpose of this study is to compare bortezomib, dexamethasone and cyclophosphamide to bortezomib and dexamethasone alone for primary refractory or relapsed multiple myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 22, 2008
Enrollment StartJan 1, 2009
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.5 years ago

Interventions

Dexamethasonedrug

Type=exact number, number=20, unit=mg, form=tablet, route=oral. The patients will receive 20 mg of dexamethasone on days 1+2,4+5,8+9,11+12 for 21 days for 8 cycles.

Bortezomibdrug

Type=exact number, number=1.3, unit=mg, form=injection, route=intravenous. The patients will receive 1.3mg/m2 on days 1,4,8,11 for 21 days for 8 cycles.

Cyclophosphamidedrug

Type=exact number, number=50, unit=mg, form=tablet, route=oral. The patients will receive 50 mg of cyclophosphamide once daily continuously from cycle 1 to 8.