CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma
NCT ID: NCT02336386
Last Updated: 2015-01-13
Study Results
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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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2014-12-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
CDD Plus Bortezomib
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
CDD
Chemotherapy
Interventions
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CDD
Chemotherapy
CDD Plus Bortezomib
Chemotherapy plus Proteasome Inhibitors
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Responsible Party
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Yuping Zhong
Chief physician
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMA-MM
Identifier Type: -
Identifier Source: org_study_id
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