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

No results posted yet for this study

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

Cyclophosphamide

300mg/m\^2 intravenously daily on day 1-3,repeated every 28 days

DRUG

Dexamethasone

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02248428 on ClinicalTrials.gov