CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
Bortezomib +4 moredrug
Likely dose
Bortezomib 1.3 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/NCT00948922
NCT00948922Phase 2Completed
CompareCT.gov

Evaluation of Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jul 29, 2009·Updated Sep 18, 2019

In Brief

A Phase 2 clinical trial evaluating Bortezomib, Melphalan, and 3 other interventions for Multiple Myeloma. Completed, enrolled 124 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2009
Enrollment StartJun 18, 2009
Primary CompletionApr 20, 2017
Study CompletionMay 14, 2019
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 16.9 years ago

Interventions

Bortezomibdrug

AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).

Melphalandrug

AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m\^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes.

Autologous Stem Cell Transplantprocedure

Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells.

Fludarabinedrug

Days -6,-5,-4,-3 Fludarabine 30 mg/m\^2/day IV

Allogeneic Stem Cell Transplantprocedure

Allogeneic Stem Cell Transplant: Allogeneic Peripheral Blood Stem Cell Rescue. Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients. Allogeneic donor stem cells may also be cryopreserved if they cannot be infused fresh.