PDD vs PAD to Treat Initially Diagnosed MM

Study Overview
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Brief Summary
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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.

Official Title
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Doxorubicin Hydrochloride Liposome vs Doxorubicin Combined With Bortizomib and Dexamethasone to Treat Initially Diagnosed Multiple Myeloma: A Randomized Prospective Clinical Study

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone
* Drug: PAD regimen: bortizomib, dexamethasone and doxorubicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDD arm<br>patients involved in PDD arm will accept chemotherapy of PDD regimen (doxorubicin hydrochloride liposome plus bortizomib and dexamethasone ) | Drug: PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone<br>* doxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong)<br>|
| Active Comparator: PAD arm<br>patients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone ) | Drug: PAD regimen: bortizomib, dexamethasone and doxorubicin<br>* doxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | sCR + CR + VGPR | 4 cycles (each cycle is 28 days) of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall remission rate | sCR + CR | 4 cycles (each cycle is 28 days) of chemotherapy | 
| Progression-free survival |  | 3 year | 
| Adverse Event |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Doxorubicin Hydrochloride