CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacy… (NCT02336386) | Clinical Trial Compass
UnknownPhase 3
CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma
China100 participantsStarted 2014-12
Plain-language summary
The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone(CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Number of patients with overall hematologic response
Timeframe: Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months)