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

Capital Medical University

Status and phase: Unknown; Phase 3

Conditions: Extramedullary Plasmacytoma

Treatments: Drug: CDD Plus Bortezomib; Drug: CDD

Study type: Interventional

Funder types: Other

Identifiers

NCT02336386

CMA-MM

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CDD Plus Bortezomib

Experimental group

Description:

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.

Treatment:

Drug: CDD Plus Bortezomib

CDD

Active Comparator group

Description:

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

Treatment:

Drug: CDD