CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma
Phase 3
- Conditions
- Extramedullary Plasmacytoma
- Interventions
- Drug: CDDDrug: CDD Plus Bortezomib
- Registration Number
- NCT02336386
- Lead Sponsor
- Beijing Chao Yang Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CDD CDD 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 CDD Plus Bortezomib CDD Plus Bortezomib 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.
- Primary Outcome Measures
Name Time Method Number of patients with overall hematologic response Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months) Complete response, very good partial response and partial response
- Secondary Outcome Measures
Name Time Method Number of patients with EMP response Assessed every 2 cyeles period is projected to be approximately 24 months response rate
Time from diagnosis ofEMP to the date of death Monthly up to 3 years Progression free survival Monthly up to 2 years Overall survival Monthly up to 3 years The median overall survival
Time from date of diagnosis of EMP to the date of first documentation of disease Monthly up to 2 years Number of adverse events Monthly up to 3 years 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.
Trial Locations
- Locations (1)
Yuping ZHONG
🇨🇳Beijing, Beijing, China