CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Filgrastim-sndz +2 morebiological
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/NCT03417284
NCT03417284Phase 2Completed

Prospective Phase I/II Trial to Jointly Optimize the Administration Schedule(s) and Dose(s) of Melphalan for Injection (Evomela) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

M.D. Anderson Cancer Center·interventional·Posted Jan 31, 2018·Updated May 1, 2025

In Brief

A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Filgrastim-sndz, and 1 other intervention for Plasma Cell Myeloma. Completed, enrolled 62 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of melphalan hydrochloride in treating participants with newly-diagnosed multiple myeloma who are undergoing a donor stem cell transplantation. Giving chemotherapy before a donor stem cell transplantation helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving melphalan hydrochloride before a donor stem cell transplantation may work better than standard chemotherapy in helping to prevent multiple myeloma from coming back.

Study Details

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

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 31, 2018
Enrollment StartOct 9, 2019
Primary CompletionJul 18, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.4 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo HSCT

Filgrastim-sndzbiological

Given SC

Melphalan Hydrochloridedrug

Given IV