Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma

• Status: Unknown status
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China
• Treatments: BB 1101; Clarithromycin; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.