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

Study Overview
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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.

Official Title
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Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients

Conditions
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Extramedullary Plasmacytoma

Intervention / Treatment
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* Drug: CDD
* Drug: CDD Plus Bortezomib


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDD Plus Bortezomib<br>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. | Drug: CDD Plus Bortezomib<br>* Chemotherapy plus Proteasome Inhibitors<br>* Other names: Chemotherapy Plus Bortezomib;|
| Active Comparator: CDD<br>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 | Drug: CDD<br>* Chemotherapy<br>* Other names: Cyclophosphamide,Liposome doxorubicin and Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with overall hematologic response | Complete response, very good partial response and partial response | Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with EMP response | response rate | Assessed every 2 cyeles period is projected to be approximately 24 months | 
| Overall survival | The median overall survival | Monthly up to 3 years | 
| Time from diagnosis ofEMP to the date of death |  | Monthly up to 3 years | 
| Progression free survival |  | Monthly up to 2 years | 
| Time from date of diagnosis of EMP to the date of first documentation of disease |  | Monthly up to 2 years | 
| Number of adverse events | Adverse events, serious adverse events, assessment of clinical laboratory values from the date of signing of the informed consent form through 30 days after the last dose of study drug. | Monthly up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bortezomib