PDD vs PAD to Treat Initially Diagnosed MM
Phase 4
- Conditions
- Multiple Myeloma
- Registration Number
- NCT02577783
- Brief Summary
The purpose of this study is to determine whether doxorubicin hydrochloride liposome is superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient with initially diagnosed multiple myeloma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Newly diagnosed and untreated multiple myeloma patients
- Patients with age between 18 and 70 years
- With a evaluable disease
- ECOG score ≤2
- NE≥1.0×10E9 /L, Plt≥50×10E9 /L, Hb≥70 g/L
- AST, ALT, ALP≤3×ULN, serum BIL≤ULN
- LVEF≥ 50%
- Not in pregnancy
- Written informed consent are acquired
Exclusion Criteria
- Severe heart failure (NYHA grade II or higher)
- Active and uncontrolled severe infection
- HIV positive
- Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride iposome or doxorubicin
- Grade 2 or higher peripheral neuropathy before treatment
- Have suffered any other malignancy in past 5 years
- Females in lactation
- Other situations that investigators consider as contra-indication for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Response rate 4 cycles (each cycle is 28 days) of chemotherapy sCR + CR + VGPR
- Secondary Outcome Measures
Name Time Method Overall remission rate 4 cycles (each cycle is 28 days) of chemotherapy sCR + CR
Progression-free survival 3 year Adverse Event 3 year
Trial Locations
- Locations (1)
the First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China