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Trial record 41 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02336386
Recruitment Status : Unknown
Verified January 2015 by Yuping Zhong, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Sponsor:
Collaborator:
Peking University People's Hospital
Information provided by (Responsible Party):
Yuping Zhong, 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.

Condition or disease Intervention/treatment Phase
Extramedullary Plasmacytoma Drug: CDD Drug: CDD Plus Bortezomib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Cyclophosphamide,Liposome Doxorubicin Dexamethasone(CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: 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.
Drug: CDD Plus Bortezomib
Chemotherapy plus Proteasome Inhibitors
Other Name: Chemotherapy Plus Bortezomib

Active Comparator: 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
Drug: CDD
Chemotherapy
Other Name: Cyclophosphamide,Liposome doxorubicin and Dexamethasone




Primary Outcome Measures :
  1. Number of patients with overall hematologic response [ Time Frame: 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 :
  1. Number of patients with EMP response [ Time Frame: Assessed every 2 cyeles period is projected to be approximately 24 months ]
    response rate

  2. Overall survival [ Time Frame: Monthly up to 3 years ]
    The median overall survival

  3. Time from diagnosis ofEMP to the date of death [ Time Frame: Monthly up to 3 years ]
  4. Progression free survival [ Time Frame: Monthly up to 2 years ]
  5. Time from date of diagnosis of EMP to the date of first documentation of disease [ Time Frame: Monthly up to 2 years ]
  6. Number of adverse events [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336386


Contacts
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Contact: Yuping ZHONG, Doctor 861051718999 zhongyp3352@126.com

Locations
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China, Beijing
Yuping ZHONG Recruiting
Beijing, Beijing, China, 100043
Contact: Yuping ZHONG, Doctor    860105171-8999    zhongyp3352@126.com   
Principal Investigator: Yuping ZHONG, Doctor         
Principal Investigator: Jin LU, Doctor         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Peking University People's Hospital
Investigators
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Principal Investigator: Yuping Zhong, Doctor Beijing Chao Yang Hospital

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Responsible Party: Yuping Zhong, Chief physician, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02336386     History of Changes
Other Study ID Numbers: CMA-MM
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015

Keywords provided by Yuping Zhong, Beijing Chao Yang Hospital:
Bortezomib

Additional relevant MeSH terms:
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Hemostatic Disorders
Doxorubicin
Liposomal doxorubicin
Multiple Myeloma
Plasmacytoma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones