Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
- Participants will begin taking the study medication in the clinic on Cycle 1 day 1.
Each treatment cycle lasts three weeks. They will take the lenalidomide (capsules)
every day for the first two weeks only (days 1-14). They will take dexamethasone
(tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and will come to the outpatient treatment
center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle
is a rest period and the participant will not be taking any study medication.
- Certain tests and procedures will be performed throughout each treatment cycle at
definitive time periods. These tests include: medical history update,
physical/neurological examination, skeletal survey (x-rays or scan), blood samples,
urine samples, optional bone marrow aspiration/tissue biopsy, 12-lead ECG, and MRI/CT
- It is expected that participants will complete at least 8 cycles of the study, which
adds up to 168 days. If the participant completes the first 8 cycles, 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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate time to progression following bortezomib, lenalidomide and dexamethasone combination therapy treatment in patients with relapsed or refractory multiple myeloma.
Paul Richardson, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|