PDD vs PAD to Treat Initially Diagnosed MM

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02577783
• Other study ID #: SZ5202
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone
doxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong)
• PAD regimen: bortizomib, dexamethasone and doxorubicin
doxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong)

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	sCR + CR + VGPR	4 cycles (each cycle is 28 days) of chemotherapy
Secondary	Overall remission rate	sCR + CR	4 cycles (each cycle is 28 days) of chemotherapy
Secondary	Progression-free survival		3 year
Secondary	Adverse Event		3 year