PDD vs PAD to Treat Initially Diagnosed MM

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02577783

Enrollment

Registered

2015-10-16

Start date

2015-10-31

Completion date

2021-12-31

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Doxorubicin Hydrochloride

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.

Interventions

DRUGPDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone

doxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong)

DRUGPAD regimen: bortizomib, dexamethasone and doxorubicin

doxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026