Status:
UNKNOWN
Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Jinling Hospital, China
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
This phase III,randomized controlled trial will enroll 130(65 each arm) newly diagnosed patients with active disease from 4 medical centers in East China. The participants are randomly equally select...
Eligibility Criteria
Inclusion
- Signed informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Diagnosed with active multiple myeloma
- Previously untreated
- Karnofsky performance status(KPS) ≥50（KPS\<50 will be allowed if related to bony disease）
- New York Heart Association(NYHA) functional ≤class III
Exclusion
- Hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics;
- Concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin;
- A history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin.
- Impaired renal function,Creatinine ≥221umol/L；
- Pregnant or breast feeding females.
- Any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT02248428
Start Date
April 1 2012
End Date
September 1 2020
Last Update
September 6 2017
Active Locations (1)
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1
Jinling Hospital
Nanjing, Jiangsu, China, 210002