NCT02986451

Clarithromycin,Lenalidomide and Dexamethasone for Relapsed/Refractory Myeloma

Efficacy and Safety Study of BiRD (Biaxin [Clarithromycin]/Revlimid [Lenalidomide]/Dexamethasone) Combination Therapy in Relapsed/Refractory Myeloma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This phase II study investigating the efficacy and safety of a combination of biaxin,lenalidomide and dexamethasone in subjects with relapsed/refractory MM.

Detailed description

The combination of lenalidomide and dexamethasone is effective in increasing the response rate, time to progression, and overall survival in patients with relapsed or refractory myeloma.Clarithromycin is an antibiotic that has shown efficacy in association with steroids and lenalidomide.Clarithromycin, lenalidomide and dexamethasone (BiRd) in newly diagnosed MM has yielded an overall response rates (ORR) of 93% and a progression-free survival (PFS) of 43 months.No prospective study of BiRd to treat relapsed or refractory myeloma has been reported so far.The goal of this phase 2 clinical trial was to assess the response rate and toxicity of a combination regimen of clarithromycin (Biaxin), lenalidomide (Revlimid), and dexamethasone (BiRD) for the treatment of relapsed/refractory MM.

Conditions

• Relapse/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	clarithromycin	Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle.
DRUG	Lenalidomide	Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
DRUG	Dexamethasone	Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-12-08
• Last updated: 2018-08-14

Locations

1 site across 1 country: China