CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 225 enrolled
Drug / intervention
Thalidomide +2 moredrug
Likely dose
Thalidomide 200 mg orally daily (days 1-28 of each cycle, escalating from 50 mg); Dexamethasone 40 mg orally on days 1-4, 9-12, 17-20; DOXIL 40 mg/m² intravenously on day 1AI-extracted
Key inclusion· 5
  • ✓Newly diagnosed, histologically confirmed multiple myeloma per IMWG criteria
  • ✓ECOG performance status 0-2
  • ✓Adequate absolute neutrophil count, platelet count, and hemoglobin
  • ✓Adequate serum calcium
Key exclusion· 6
  • ✕Prior treatment with dexamethasone for multiple myeloma
  • ✕Peripheral neuropathy grade 2 or higher
  • ✕Left ventricular ejection fraction (LVEF) less than 45%
  • ✕History of life-threatening thromboembolic events (MI, PE, stroke, or others) within 1 year before enrollment

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

Search/NCT00097981
NCT00097981Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Multi-Center Trial Comparing Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Subjects With Newly Diagnosed Multiple Myeloma

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Dec 2, 2004·Updated Apr 7, 2017

In Brief

A Phase 3 clinical trial evaluating Thalidomide, Dexamethasone, and 1 other intervention for Multiple Myeloma. Completed, enrolled 225 participants across 58 sites.

Detailed Summary

The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsTibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2, 2004
Enrollment StartJan 1, 2005
Primary CompletionOct 1, 2007
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 21.6 years ago

Interventions

Thalidomidedrug

Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.

Dexamethasonedrug

Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.

DOXILdrug

DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.