Status unknownNCT02577783Updated Feb 5, 2020

PDD vs PAD to Treat Initially Diagnosed MM

A Phase 4 interventional study of PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone and PAD regimen: bortizomib, dexamethasone and doxorubicin in Multiple Myeloma, sponsored by The First Affiliated Hospital of Soochow University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by The First Affiliated Hospital of Soochow University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Multiple Myeloma

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Keywords

Doxorubicin Hydrochloride

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 64 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 64 participants (estimated)

Study arms

Experimental
PDD arm
patients involved in PDD arm will accept chemotherapy of PDD regimen (doxorubicin hydrochloride liposome plus bortizomib and dexamethasone )
Drug: PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone
Active comparator
PAD arm
patients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone )
Drug: PAD regimen: bortizomib, dexamethasone and doxorubicin

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)

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02577783
Lead sponsor: The First Affiliated Hospital of Soochow University
Responsible party: Sponsor
First posted: Oct 16, 2015
Start date: Oct 2015
Primary completion: Oct 2021 (estimated)
Completion: Dec 2021 (estimated)
Last update: Feb 5, 2020

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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