Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma
NCT02248428 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2017-09-06
Summary
Due to economic reasons, thalidomide is still widely used as a first line drug for Multiple Myeloma patients in China. However,the efficacy of CTd is still lower than the therapeutic regimens with new drugs. Clarithromycin may have partly efficacy in association with steroids and thalidomide for Multiple Myeloma patients. This multicenter, randomized, phase 3 clinical trial is proposed to explore whether clarithromycin could potentiate responsiveness of CTd (Cyclophosphamide, Thalidomide and Dexamethasone) regimen in Newly Diagnosed Multiple Myeloma patients. The trial will also evaluate the side effects caused by the combination of these drugs.
Conditions
Interventions
- DRUG
-
Clarithromycin
500mg orally daily on days 1-28,repeated every 28 days
- DRUG
-
Thalidomide
Thalidomide 100-200mg orally per night on days 1-28,repeated every 28 days
- DRUG
-
300mg/m\^2 intravenously daily on day 1-3,repeated every 28 days
- DRUG
-
40 mg orally weekly on days 1,8,15,22,repeated every 28 days
Sponsors & Collaborators
-
Jinling Hospital, China
lead OTHER
Principal Investigators
-
Yongping Zhai, doctor · Jinling Hospital, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2019-09-30
- Completion
- 2020-09-30
Countries
- China
Study Locations
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