CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Bortezomib +11 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/NCT00793572
NCT00793572Phase 2Completed

Tandem Autologous HCT/Nonmyeloablative Allogeneic HCT From HLA-Matched Related and Unrelated Donors Followed by Bortezomib Maintenance Therapy for Patients With High-Risk Multiple Myeloma

Fred Hutchinson Cancer Center·interventional·Posted Nov 19, 2008·Updated Jan 22, 2020

In Brief

A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Bortezomib, and 9 other interventions for Refractory Plasma Cell Myeloma. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This phase II trial studies the side-effects and anti-cancer effects of giving an autologous or syngeneic stem cell transplant followed by an allogeneic donor stem cell transplant and bortezomib. Patients treated on this trial have newly diagnosed high-risk, relapsed, or refractory multiple myeloma (MM). Giving chemotherapy before an autologous stem cell transplant slows or stops the growth of cancer cells by preventing them from dividing or killing them. Stem cells that were harvested earlier from the patient's blood and frozen are then returned to the patient to replace the blood-forming cells that were destroyed by chemotherapy. Giving chemotherapy and total-body irradiation before an allogeneic donor stem cell transplant also prevents the patient's immune system from rejecting the donor's stem cells. Undergoing an autologous or syngeneic stem cell transplantation followed by an allogeneic donor stem cell transplant and bortezomib may be overall more effective in killing cancer cells.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2008
Enrollment StartOct 1, 2008
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 17.6 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo transplantation

Bortezomibdrug

Given SC

Cyclosporinedrug

Given IV

Cyclosporinedrug

Given PO

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Melphalandrug

Given IV

Mycophenolate Mofetildrug

Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo transplantation

Peripheral Blood Stem Cell Transplantationprocedure

Undergo transplantation

Syngeneic Bone Marrow Transplantationprocedure

Undergo transplantation

Total-Body Irradiationradiation

Undergo radiotherapy