PDD vs PAD to Treat Initially Diagnosed MM

NCT02577783 | Unknown Phase 4

• 1 other identifier: SZ5202
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Doxorubicin Hydrochloride

Outcome Measures

Primary Outcomes (1)

• Response rate

  sCR + CR + VGPR

  4 cycles (each cycle is 28 days) of chemotherapy

Secondary Outcomes (3)

• Overall remission rate

  4 cycles (each cycle is 28 days) of chemotherapy

• Progression-free survival

  3 year

• Adverse Event

  3 year

Study Arms (2)

PDD arm

EXPERIMENTAL

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

PAD arm

ACTIVE COMPARATOR

patients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone )

Drug: PAD regimen: bortizomib, dexamethasone and doxorubicin

Interventions

PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone DRUG

doxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong)

PDD arm

PAD regimen: bortizomib, dexamethasone and doxorubicin DRUG

doxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong)

PAD arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 16, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CN (1)