CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
bortezomib +9 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/NCT00792142
NCT00792142Phase 2Completed
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A Phase II Study of Maintenance Treatment With Sequential Bortezomib, Thalidomide and Dexamethasone Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Multiple Myeloma

City of Hope Medical Center·interventional·Posted Nov 17, 2008·Updated Aug 19, 2021

In Brief

A Phase 2 clinical trial evaluating bortezomib, dexamethasone, and 8 other interventions for Multiple Myeloma and Plasma Cell Neoplasm and Neurotoxicity. Completed, enrolled 45 participants across 1 site.

Detailed Summary

RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell transplant in patients with multiple myeloma. PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it works in treating patients with stage I-III multiple myeloma.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 17, 2008
Enrollment StartJan 16, 2008
Primary CompletionApr 21, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.6 years ago

Interventions

bortezomibdrug

Given IV

dexamethasonedrug

Given orally

melphalandrug

Given IV

thalidomidedrug

Given orally

cytogenetic analysisgenetic

Performed on baseline and post transplant bone marrow specimens

fluorescence in situ hybridizationgenetic

Performed on baseline and post transplant bone marrow specimens

laboratory biomarker analysisother

Baseline, post transplant and prior to start of bortezomib, every 3 months post transplant for the first year, after 6 cycles of bortezomib, every year after transplant for 2-4 years.

questionnaire administrationother

Completed at baseline (within 6 weeks prior to enrollment) and at 2 months post transplant and once a month after that for the first year. For the second year the questionnaire will be completed every 3 months as long as on thalidomide for the duration of the study.

autologous hematopoietic stem cell transplantationprocedure

Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan

peripheral blood stem cell transplantationprocedure

Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan