This phase II study investigating the efficacy and safety of a combination of biaxin,lenalidomide and dexamethasone in subjects with relapsed/refractory MM.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle.
Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment
Time frame: 30 months
Progression Free Survival (PFS)
PFS, defined as time from first dose of study treatment to progression or death due to any cause, as assessed by investigator
Time frame: 30 months
Overall survival (OS)
OS, defined as time from first dose of study treatment to death
Time frame: 30 months
Safety of combination therapy assessed using the National Cancer institute-Common Toxicology Criteria (NCI-CTC) grade scale for AEs and Lab assessments
Safety of combination therapy (Clarithromycin,lenalidomide and dexamethasone) as assessed by toxicity, which will be assessed using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale for Adverse Events and for laboratory assessments (v4.03) that include biochemistry, hematology, urinalysis; special safety assessments that include LVEF, Thyroid function Creatinine clearance and ECGs (electrocardiograms).
Time frame: 30 months
Genomic Predictors of Response Rate and PFS
Blood (about 1-2 tablespoons) collected for biomarker and routine tests and to evaluate the ORR and PFS.
Time frame: 30 months
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