PDD vs PAD to Treat Initially Diagnosed MM

Soochow University

Status and phase: Unknown; Phase 4

Conditions: Multiple Myeloma

Treatments: Drug: PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone; Drug: PAD regimen: bortizomib, dexamethasone and doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02577783

SZ5202

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

PDD arm

Experimental group

Description:

patients involved in PDD arm will accept chemotherapy of PDD regimen (doxorubicin hydrochloride liposome plus bortizomib and dexamethasone )

Treatment:

Drug: PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone

PAD arm

Active Comparator group

Description:

patients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone )

Treatment:

Drug: PAD regimen: bortizomib, dexamethasone and doxorubicin