Back to resultsPDD vs PAD to Treat Initially Diagnosed MM
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone
PAD regimen: bortizomib, dexamethasone and doxorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Doxorubicin Hydrochloride
Eligibility 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
Sites / Locations
- the First Affiliated Hospital of Soochow University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PDD arm
PAD arm
Arm Description
patients involved in PDD arm will accept chemotherapy of PDD regimen (doxorubicin hydrochloride liposome plus bortizomib and dexamethasone )
patients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone )
Outcomes
Primary Outcome Measures
Response rate
sCR + CR + VGPR
Secondary Outcome Measures
Overall remission rate
sCR + CR
Progression-free survival
Adverse Event
Full Information
NCT ID
NCT02577783
First Posted
October 7, 2015
Last Updated
February 4, 2020
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT02577783
Brief Title
PDD vs PAD to Treat Initially Diagnosed MM
Official Title
Doxorubicin Hydrochloride Liposome vs Doxorubicin Combined With Bortizomib and Dexamethasone to Treat Initially Diagnosed Multiple Myeloma: A Randomized Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Doxorubicin Hydrochloride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PDD arm
Arm Type
Experimental
Arm Description
patients involved in PDD arm will accept chemotherapy of PDD regimen (doxorubicin hydrochloride liposome plus bortizomib and dexamethasone )
Arm Title
PAD arm
Arm Type
Active Comparator
Arm Description
patients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone )
Intervention Type
Drug
Intervention Name(s)
PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone
Intervention Description
doxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong)
Intervention Type
Drug
Intervention Name(s)
PAD regimen: bortizomib, dexamethasone and doxorubicin
Intervention Description
doxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong)
Primary Outcome Measure Information:
Title
Response rate
Description
sCR + CR + VGPR
Time Frame
4 cycles (each cycle is 28 days) of chemotherapy
Secondary Outcome Measure Information:
Title
Overall remission rate
Description
sCR + CR
Time Frame
4 cycles (each cycle is 28 days) of chemotherapy
Title
Progression-free survival
Time Frame
3 year
Title
Adverse Event
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
the First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
12. IPD Sharing Statement
Learn more about this trial
PDD vs PAD to Treat Initially Diagnosed MM
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