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Trial Title:
A Study of PAD Versus Velcade, Cyclophosphamide and Dexamethasone (VCD) Treatment in Subjects With Multiple Myeloma
NCT ID:
NCT01868828
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma
Combination Therapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PAD
Description:
Induction Therapy of PAD for 4 cycles.
Arm group label:
PAD Followed by ASCT
Other name:
Induction Therapy
Intervention type:
Drug
Intervention name:
VCD
Description:
Induction Therapy of VCD for 4 cycles.
Arm group label:
VCD Followed by ASCT
Other name:
Induction Therapy
Intervention type:
Other
Intervention name:
ASCT
Description:
Not suitable for transplant patients will continue accept treatment for 8 cycles.
Arm group label:
PAD Followed by ASCT
Arm group label:
VCD Followed by ASCT
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, screening, treatment and follow-up.
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 and exclusion criteria.
Treatment
Eligible patients are randomly assigned to receive either treatment PAD or VCD. All
eligible subjects will be evaluated after 4 cycles treatment. According to the assessment
of researchers and the willingness of patients to decide whether to autologous stem-cell
transplantation (ASCT). Suitable for transplant patients will accept hematopoietic stem
cell transplantation. Not suitable for transplant patients will continue accept treatment
for 8 cycles. The patients who accept more than 4 cycles treatment will receive efficacy
evaluation.
Follow-up
All patients will receive 12 months of follow-up after the treatment period. Follow-up at
4, 6, 8 and 12 month after the treatment period respectively. Subjects who have disease
progression or accept other resistance myeloma therapy during the 12 months of follow-up
phase will stop assessed about the study and start followed up only for survival status
every 6 months through telephone interviews or to research center follow-up. All patients
will accept the follow-up for survival until last case patient who complete follow-up.
Safety will be evaluated throughout the study by assessment of adverse events (AEs),
physical examination, vital signs and clinical laboratory findings.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men or women aged <65 years.
2. Previously untreated subjects with multiple myeloma.
3. No clinically significant cardiac amyloidosis (Echocardiography septal≤10mm, brain
natriuretic peptide (BNP) < 500).
4. Pulmonary infection (if any) must be controlled effectively.
5. 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）；
6. Liver function (aminotransferase, bilirubin）?2 x the upper limit of normal (ULN).
7. Expected lifetime More than 3 months.
8. 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 Criteria:
1. Patients with relapsed multiple myeloma.
2. Need to change the program according to the researchers' evaluated patients with
disease progression during treatment.
3. 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.
4. Has a history of allergic reaction to compounds containing boron or mannitol.
5. Severe neuropathy may affect the treatment, according to the researchers to
determine.
6. 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.
7. Concurrent treatment with another investigational agent.
8. Pregnant or breast-feeding women.
Gender:
All
Minimum age:
N/A
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital, Institute of Hematology, Peking University
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Lu, PhD
Email:
onco_velcade123@163.com
Start date:
May 2013
Completion date:
May 2017
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01868828
