An Open-Label Phase I/II Study of the Safety and Efficacy of Bortezomib, Lenalidomide and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
- The safe dose of dexamethasone is already known. The dose of bortezomib and
lenalidomide will be increased during the study until the best and safest amount (or
dose) is identified. The participant's dose of the study drugs will depend on when
they enter the study.
- In this study each cycle will be 21 days and participants will begin the study
medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily
for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1,
2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient
treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study
medication will be given.
- During the course of the study treatment, tests and procedures will be performed at
designated time periods. This includes; medical history updates, physical/neurological
examinations, skeletal survey (x-rays or scan), blood samples, optional bone marrow
aspiration/tissue biopsy, urine samples, 12-lead ECG, and MRI/CT scan (if needed).
- It is expected that study participants will receive study treatment for 8 cycles (168
days). If the participant completes the first 8 cycles of the study, has stable or
responding disease and has not experienced bad side effects, they will be allowed to
continue treatment on a maintenance schedule, detailed in the protocol, at the study
doctor's discretion.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients
3 years
Yes
Paul Richardson, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
06-150
NCT00378105
August 2006
February 2016
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |