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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Chao Yang Hospital
• Collaborator: Peking University People's Hospital
• Treatments: BB 1101; Bortezomib; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin

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