Clinical trial · Interventional
CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma
Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients
NCT02336386CI-TRIAL-00016600unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extramedullary Plasmacytoma | Extraosseous Plasmacytoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDD | Drug | — | UNRESOLVED |
| CDD Plus Bortezomib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CDD Plus Bortezomib
- 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.
- interventionNames
- Drug: CDD Plus Bortezomib
- type
- ACTIVE_COMPARATOR
- label
- CDD
- 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
- interventionNames
- Drug: CDD
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.