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

Extramedullary Plasmacytoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02336386
• Other study ID #: CMA-MM
• Status: Recruiting
• Phase: Phase 3
• First received: January 8, 2015
• Last updated: January 12, 2015
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2015
• Source: Beijing Chao Yang Hospital
• Contact: Yuping ZHONG, Doctor
• Phone: 861051718999
• Email: zhongyp3352[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extramedullary Plasmacytoma
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Drug:
• CDD
Chemotherapy
• CDD Plus Bortezomib
Chemotherapy plus Proteasome Inhibitors

Locations

Country	Name	City	State
China	Yuping ZHONG	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital	Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Number of patients with EMP response	response rate	Assessed every 2 cyeles period is projected to be approximately 24 months	No
Secondary	Overall survival	The median overall survival	Monthly up to 3 years	No
Secondary	Time from diagnosis ofEMP to the date of death		Monthly up to 3 years	No
Secondary	Progression free survival		Monthly up to 2 years	No
Secondary	Time from date of diagnosis of EMP to the date of first documentation of disease		Monthly up to 2 years	No
Secondary	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	Yes