Randomized Phase II Study in Elderly Patients With Newly Diagnosed Multiple.
Status:
Not yet recruiting
Trial end date:
2027-10-01
Target enrollment:
Participant gender:
Summary
To compare the efficacy and safety of bortezomib, lenalidomide and dexamethasone in elderly
frail patients with newly diagnosed multiple myeloma
1. Primary Study Objective
- Progression-Free Survival
: The time from randomization into the date of first observation of documented disease
progression or any-kinds of death.
2. Secondary Study Objectives 1) Complete Response (CR)
- Response will be determined by the International Myeloma Working Group Response
Criteria
- CR is defined as negative immunofixation on the serum and urine and disappearance
of any soft tissue plasmacytoma and < 5% of plasma cells in bone marrow aspirates
- The determination of stringent CR and Imaging will be done 2) Overall response rate
consisting of complete response, very good partial response, and partial response
3) Overall survival (OS)
- The time from randomization into the date of any-kinds of death. 4) Time to
next treatment
- The time from randomization into the first date of second-line treatment. 5)
Toxicity profiles