Clinical trial NCT02336386: CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma
Official title: Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Extramedullary Plasmacytoma
Keywords: Bortezomib
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
First posted: 2015-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with overall hematologic response
timeFrame: Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months)
Secondary outcomes:
measure: Number of patients with EMP response
timeFrame: Assessed every 2 cyeles period is projected to be approximately 24 months
measure: Overall survival
timeFrame: Monthly up to 3 years
measure: Time from diagnosis ofEMP to the date of death
timeFrame: Monthly up to 3 years
measure: Progression free survival
timeFrame: Monthly up to 2 years
measure: Time from date of diagnosis of EMP to the date of first documentation of disease
timeFrame: Monthly up to 2 years
measure: Number of adverse events
timeFrame: Monthly up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yuping ZHONG
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Yuping Zhong, Doctor
role: PRINCIPAL_INVESTIGATOR
References: