CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Busulfan +4 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/NCT01605032
NCT01605032Phase 2Completed

Phase II Study Assessing the Efficacy and Toxicity of PK--directed Intravenous Busulfan in Combination With High--Dose Melphalan and Bortezomib as Conditioning Regimen for First--Line Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma

Albert Einstein College of Medicine·interventional·Posted May 24, 2012·Updated Aug 20, 2020

In Brief

A Phase 2 clinical trial evaluating Busulfan, Melphalan, and 3 other interventions for DS Stage I Plasma Cell Myeloma and 3 related conditions. Completed, enrolled 19 participants across 4 sites.

Detailed Summary

This phase II trial studies how well busulfan, melphalan, and bortezomib before first-line stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy before a peripheral blood stem cell transplant may stop the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 14.1 years ago

Interventions

Busulfandrug

Given IV

Melphalandrug

Given IV

Bortezomibdrug

Given IV

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous PBSCT

Peripheral Blood Stem Cell Transplantationprocedure

Undergo autologous PBSCT