drugset / Trial / NCT02248428

Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma

NCT02248428

Phase 3 Unknown 130 enrolled Jinling Hospital, China
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-04
Primary completion
2019-09
Completion
2020-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 500 mg Oral
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Background Dexamethasone Small molecule 40 mg Oral
Background Thalidomide Other / unclassified 100 mg Oral
Background Thalidomide Other / unclassified 200 mg Oral

Indications