A Phase 1 Dose Escalating Trial of Bortezomib in Combination With Lenalidomide in Patients With Myelodysplasia

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Myelodysplasia
Interventions
DRUG

Bortezomib

First cohort: Bortezomib 0.7mg/m2 IV on Days on Days 1, 4, 8, and 11. Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

DRUG

Bortezomib

Second cohort: Bortezomib 1mg/m2 IV on Days 1, 4, 8, and 11 Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

DRUG

Bortezomib

Third Cohort: Bortezomib 1.3mg/m2 IV on Days 1, 4, 8, and 11 of each cycle Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

DRUG

Lenalidomide

Lenalidomide 10 mg PO QD on Days 1 -21 followed by a 7 day rest period

Trial Locations (2)

02114

Massachusetts General Hospital, Boston

02115

Dana Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Dana-Farber Cancer Institute

OTHER

lead

Massachusetts General Hospital

OTHER