Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)

PHASE3TerminatedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
Multiple Myeloma
Interventions
DRUG

zoledronic acid

Patients were randomized to receive zoledronic acid I.V. on either Day 1 or 15 of each cycle. This schedule continued monthly as long as the patient remained on study. The dose was calculated based on the patients' monthly creatinine clearance.

DRUG

dexamethasone

As outlined in VAD Treatment arm and Thalidomide and Dexamethasone Treatment arm

DRUG

thalidomide

As outlined in Thalidomide and Dexamethasone Treatment arm

DRUG

vincristine

As outlined in VAD Treatment Arm

DRUG

adriamycin

As outlined in VAD Treatment arm

Trial Locations (5)

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

33756

Morton Plant Hospital, Clearwater

33805

Watson Clinic, Lakeland

33949

Fawcett Memorial Hospital, Port Charlotte

00921

San Juan VA Hospital, San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER