CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 177 enrolled
Drug / intervention
melphalan +2 moredrug
Likely dose
melphalan 50 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/NCT00325416
NCT00325416Phase 2Completed
CompareCT.gov

A Study of Intensive-Dose Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma.

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted May 12, 2006·Updated Mar 14, 2018

In Brief

A Phase 2 clinical trial evaluating melphalan, topotecan (TPT), and 1 other intervention for Multiple Myeloma. Completed, enrolled 177 participants across 1 site.

Detailed Summary

The purpose of this research study is to determine the safest dose of topotecan when given in a high dose before a stem cell transplant; topotecan will be given with melphalan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsGlaxoSmithKline, National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 12, 2006
Enrollment StartNov 19, 2001
Primary CompletionJul 15, 2013
Study CompletionJan 30, 2018
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 20.1 years ago

Interventions

melphalandrug

(Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)

topotecan (TPT)drug

Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD)

Autologous Stem Cell Rescueprocedure

Day 0