CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma

NCT ID: NCT02336386

Last Updated: 2015-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone(CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.

Detailed Description

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Conditions

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Extramedullary Plasmacytoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CDD Plus Bortezomib

Patients will receive Bortezomib (1.3mg/m2) Subcutaneous injection on Days 1, 4,8,11 and plus dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, Liposome doxorubicin 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity.

Group Type EXPERIMENTAL

CDD Plus Bortezomib

Intervention Type DRUG

Chemotherapy plus Proteasome Inhibitors

CDD

Dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, doxorubicin Dexamethasone 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity

Group Type ACTIVE_COMPARATOR

CDD

Intervention Type DRUG

Chemotherapy

Interventions

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CDD

Chemotherapy

Intervention Type DRUG

CDD Plus Bortezomib

Chemotherapy plus Proteasome Inhibitors

Intervention Type DRUG

Other Intervention Names

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Cyclophosphamide,Liposome doxorubicin and Dexamethasone Chemotherapy Plus Bortezomib

Eligibility Criteria

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Inclusion Criteria

* Male or female patients from 18 to 80
* Biopsy-proven EMP with relapsed or refractory Myeloma disease. Patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
* Disease requiring further treatment
* Measurable disease such as M protein and Objective and measurable of EMP
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
* Meet the clinical laboratories criteria as specified in the protocol
* Voluntary written consent

Exclusion Criteria

* Female patients who are lactating, breastfeeding or pregnant
* Evidence of current uncontrolled cardiovascular conditions as specified in study protocol
* Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of EMP.
* Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Ongoing or active infection, known HIV positive, active hepatitis B or C infection
* Psychiatric illness/social situations that would limit compliance with study requirements
* Known allergy to any of the study medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuping Zhong

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuping Zhong, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

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Yuping ZHONG

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuping ZHONG, Doctor

Role: CONTACT

861051718999

Facility Contacts

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Yuping ZHONG, Doctor

Role: primary

860105171-8999

Other Identifiers

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CMA-MM

Identifier Type: -

Identifier Source: org_study_id

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