Phase II Study of Thalidomide, Clarithromycin, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

July 31, 2010

Study Completion Date

September 17, 2020

Conditions
Multiple Myeloma
Interventions
DRUG

thalomid

"Cycles 1-4~• Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle)"

DRUG

lenalidomide

"During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation)~• Lenalidomide (25 mg daily days 1-21 of every 28 day cycle)~During BiRD phase • 25mg daily days 1-21 of every 28 day cycle)~During Maintenance Phase~• 25 mg daily for days 1-21 out of a 28 day cycle"

DRUG

clarithromycin

"During T-BiRD Phase • Clarithromycin (500mg twice daily for each 28 day cycle)~During BiRD Phase:~• Clarithromycin (500mg twice daily for each 28 day cycle)"

DRUG

dexamethasone

"During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation)~• Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)~During BiRD Phase:~• Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)~During Maintenance Phase~• Dexamethasone 20 mg weekly (days 1,8, 15, 22 out of a 28 day cycle)"

Trial Locations (1)

10021

Weill Medical College of Cornell University, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER