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PDD vs PAD to Treat Initially Diagnosed MM

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ClinicalTrials.gov Identifier: NCT02577783
Recruitment Status : Recruiting
First Posted : October 16, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone Drug: PAD regimen: bortizomib, dexamethasone and doxorubicin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Doxorubicin Hydrochloride Liposome vs Doxorubicin Combined With Bortizomib and Dexamethasone to Treat Initially Diagnosed Multiple Myeloma: A Randomized Prospective Clinical Study
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


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)




Primary Outcome Measures :
  1. Response rate [ Time Frame: 4 cycles (each cycle is 28 days) of chemotherapy ]
    sCR + CR + VGPR


Secondary Outcome Measures :
  1. Overall remission rate [ Time Frame: 4 cycles (each cycle is 28 days) of chemotherapy ]
    sCR + CR

  2. Progression-free survival [ Time Frame: 3 year ]
  3. Adverse Event [ Time Frame: 3 year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577783


Locations
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China, Jiangsu
the First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Jia Chen, M.D.    +86 512 67781856    chenjiasuzhou@gmail.com   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University

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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT02577783     History of Changes
Other Study ID Numbers: SZ5202
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Keywords provided by The First Affiliated Hospital of Soochow University:
Doxorubicin Hydrochloride

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents