CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3 enrolled
Drug / intervention
bortezomib +5 moredrug
Likely dose
Not stated in 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/NCT01706666
NCT01706666Phase 2Completed

A Phase II Randomized Study of Three Subcutaneous Bortezomib-based Consolidation Treatments for Patients Completing Induction Therapy and Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma

Mayo Clinic·interventional·Posted Oct 15, 2012·Updated Sep 17, 2018

In Brief

A Phase 2 clinical trial evaluating bortezomib, cyclophosphamide, and 4 other interventions for Stage I Multiple Myeloma and 2 related conditions. Completed, enrolled 3 participants across 4 sites.

Detailed Summary

This randomized phase II trial studies how well giving bortezomib with or without combination chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bortezomib is more effective with or without combination chemotherapy in the post transplant setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2012
Enrollment StartDec 7, 2012
Primary CompletionJul 10, 2014
Study CompletionMay 17, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.7 years ago

Interventions

bortezomibdrug

Given SC

cyclophosphamidedrug

Given PO

lenalidomidedrug

Given PO

laboratory biomarker analysisother

Correlative studies

dexamethasonedrug

Given PO

quality-of-life assessmentprocedure

Ancillary studies