Multiple Myeloma Clinical Trial
Official title:
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
The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in the combination for treating patients in this setting.
- Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment
cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first
two weeks only (days 1-14). They took dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9,
11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day
1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did
not take any study medication.
- Certain tests and procedures were performed throughout each treatment cycle at
definitive time periods. These tests included: 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
(if needed).
- It was expected that participants were going to complete at least 8 cycles of the
study, which adds up to 168 days. If the participant completed the first 8 cycles, had
stable or responding disease and had not experienced bad side effects, they were
allowed to continue treatment on a maintenance schedule, detailed in the protocol, at
the study doctor's discretion.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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