PDD vs PAD to Treat Initially Diagnosed MM

February 4, 2020 updated by: The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
doxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong)
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
doxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZ5202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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