Status:
UNKNOWN
A Study of PAD Versus Velcade, Cyclophosphamide and Dexamethasone (VCD) Treatment in Subjects With Multiple Myeloma
Lead Sponsor:
Peking University People's Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE4
Brief Summary
A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately 50 previously untreated subjects with multiple myeloma will be enrolled. The study will consist of 6 phases, ...
Detailed Description
Screening At the screening visit, informed consent will be obtained from all subjects who are deemed potentially eligible for enrollment in the study, according to the protocol-specified inclusion an...
Eligibility Criteria
Inclusion
- Men or women aged \<65 years.
- Previously untreated subjects with multiple myeloma.
- No clinically significant cardiac amyloidosis (Echocardiography septal≤10mm, brain natriuretic peptide (BNP) \< 500).
- Pulmonary infection (if any) must be controlled effectively.
- Chronic viral hepatitis (if any) must be controlled effectively.(Subjects with HBs Ag positive need to monitor hepatitis B virus-DNA (HBV-DNA )quantitative test regularly）；
- Liver function (aminotransferase, bilirubin）?2 x the upper limit of normal (ULN).
- Expected lifetime More than 3 months.
- Be able to read and sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion
- Patients with relapsed multiple myeloma.
- Need to change the program according to the researchers' evaluated patients with disease progression during treatment.
- Had uncontrolled or severe cardiovascular disease. Had a myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
- Has a history of allergic reaction to compounds containing boron or mannitol.
- Severe neuropathy may affect the treatment, according to the researchers to determine.
- According to the program or the investigator's judgment, the patient is suffering from a serious physical illness or mental illness may interfere with participation in this clinical study.
- Concurrent treatment with another investigational agent.
- Pregnant or breast-feeding women.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01868828
Start Date
May 1 2013
End Date
May 1 2017
Last Update
June 6 2013
Active Locations (1)
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1
Peking University People's Hospital, Institute of Hematology, Peking University
Beijing, Beijing Municipality, China, 100044