Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Phase 3 Completed 198 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection) and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and Dexamethasone (VAD).

Timeline

Start: 2000-10
Primary completion: —
Completion: 2004-06

Publications

Results Rifkin RM, Gregory SA, Mohrbacher A, Hussein MA. Pegylated liposomal doxorubicin, vincristine, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristine, and dexamethasone in patients with newly diagnosed multiple myeloma: a Phase III multicenter randomized trial. Cancer. 2006 Feb 15;106(4):848-58. doi: 10.1002/cncr.21662.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doxorubicin	Other / unclassified	9 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	40 mg/m2	Intravenous
Subject	Vincristine	Small molecule	0.4 mg	Intravenous
Subject	Vincristine	Small molecule	1.4 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	40 mg	Oral

Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications