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

NCT02336386 | Unknown Phase 3

• 1 other identifier: CMA-MM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Extramedullary Plasmacytoma

Keywords

Bortezomib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of patients with EMP response

  Assessed every 2 cyeles period is projected to be approximately 24 months

• 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

Study Arms (2)

CDD Plus Bortezomib

EXPERIMENTAL

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

CDD

ACTIVE COMPARATOR

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

Interventions

CDD DRUG

Chemotherapy

Also known as: Cyclophosphamide,Liposome doxorubicin and Dexamethasone

CDD

CDD Plus Bortezomib DRUG

Chemotherapy plus Proteasome Inhibitors

Also known as: Chemotherapy Plus Bortezomib

CDD Plus Bortezomib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Peking University People's Hospital: collaborator

Study Sites (1)

Yuping ZHONG

Beijing, Beijing Municipality, 100043, China

RECRUITING

MeSH Terms

Interventions

Cyclophosphamide; Dexamethasone; Bortezomib; Drug Therapy

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Yuping Zhong, Doctor

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuping ZHONG, Doctor

CONTACT

861051718999; zhongyp3352@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

CN (1)