PDD vs PAD to Treat Initially Diagnosed MM

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin

Criteria

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