PDD vs PAD to Treat Initially Diagnosed MM

Phase 4

• Conditions: Multiple Myeloma

• Registration Number: NCT02577783
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-16
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Primary Completion: 2021-10
• Study Completion: 2021-12

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