The purpose of this study is to evaluate the efficacy and safety of paclitaxel in combination with cyclophosphamide and dexamethasone in chinese patients with relapsed/refractory multiple myeloma.
Treatment for relapsed/refractory multiple myeloma (MM)remains a crucial challenge.The investigators have previously shown that the combination of paclitaxel and cyclophosphamide acts synergistically to induce apoptosis of myeloma cells in vitro. Based on these preclinical studies, the investigators initiated a phase II clinical trial of paclitaxel 175 mg/m(2) IV over 3 h d1 combined with cyclophosphamide 200 mg/m(2) IV over 30-60 min d1,3,5 and dexamethasone 20mg IV over 30-60 min d1-4 in patients with relapsed or refractory MM. This regimen was administered every four weeks for a total of six cycles
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Paclitaxel 170 mg/m(2) IV over 3 h d1
Cyclophosphamide 200mgmg/m(2) IV d1,3,5
Dexamethasone 20mg iv d1-4
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 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
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