CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Doxil +2 moredrug
Likely dose
Doxil 40 mg/m² IV on day 1, thalidomide 50-100 mg daily days 1-28, dexamethasone 40 mg on days 1-4 and 15-18 of each cycleAI-extracted
Key inclusion· 6
  • ✓Active, symptomatic multiple myeloma with no prior chemotherapy
  • ✓Durie-Salmon Stage II-III A/B or Stage I with at least 2 poor prognostic indicators
  • ✓Ages 18-75 years
  • ✓SWOG performance status 3 or better
Key exclusion· 10
  • ✕Prior anthracycline therapy
  • ✕Hypersensitivity to doxorubicin or Doxil components
  • ✕History of mediastinal radiation
  • ✕Myocardial infarction within 6 months of enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00222105
NCT00222105Phase 2Completed
CompareCT.gov

Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

University of Kansas Medical Center·interventional·Posted Sep 22, 2005·Updated Jul 2, 2017

In Brief

A Phase 2 clinical trial evaluating Doxil, Thalidomide, and 1 other intervention for Multiple Myeloma. Completed, enrolled 25 participants.

Detailed Summary

Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
Countries--
CollaboratorsOrtho Biotech, Inc.

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartNov 1, 2002
Primary CompletionApr 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 20.8 years ago

Interventions

Doxildrug

Doxil 40 mg/m2 IV day 1

Thalidomidedrug

50-100 mg day 1-28

Dexamethasonedrug

Dexamethasone 40 mg day 1-4 and 15-18