Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma
A Prospective, Open-label, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone(VMP) for Initial Treatment in Patients With Multiple Myeloma Who do Not Undergo Autologous Stem Cell Transplantation
2 other identifiers
observational
171
1 country
18
Brief Summary
The purpose of this study is to assess the 2-year progression-free survival rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2011
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 15, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedJune 30, 2015
June 1, 2015
3 years
June 15, 2015
June 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-year Progression-free Survival Rate
Progression-free survival rate: the length of time from the day when Bortezomib was first administered to disease progression or death, whichever comes first, in 2 years.
Up to 2 years
Secondary Outcomes (5)
Time to Response
up to 2 years
Overall Response Rate
up to 2 years
Complete Response Rate
up to 2 years
Time to Next therapy
up to 2 years
Time to Disease Progression
up to 2 years
Study Arms (1)
Bortezomib, Melphalan, Prednisone (VMP) Group
Participants will not receive any intervention in this study. Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
Interventions
Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.
Participants receiving Melphalan 9 mg/m\^2 will be observed in this study.
Participants receiving Prednisone 60 mg/m\^2 will be observed in this study.
Eligibility Criteria
Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
You may qualify if:
- Participants who are naïve to chemotherapy for multiple myeloma and not eligible for autologous stem cell transplantation
- Participants with symptomatic multiple myeloma: a) Intramedullary monoclonal plasma cells greater than or equal to (\>=) 10% or histologically confirmed plasmacytoma; b) Presence of monoclonal protein in the serum or urine; c) Myeloma-related organ impairment as defined in protocol
- Participants with presence of an illness that is detectable by definitions as defined in protocol
- Postmenopausal, sterilized or sexually inactive women, including women of childbearing potential who exercise effective contraceptive measures before and during the clinical trial
You may not qualify if:
- Participants with previous experience of receiving a therapy for multiple myeloma (excluding radiotherapy and dexamethasone \< 160mg in total)
- Participants with severe peripheral neuropathy (Grade \>= 2 by NCI CTC version 4.0)
- Pregnant or breastfeeding mothers
- Participants with mental illness that can interfere with his/her cooperation with the therapy or the monitoring conditions of the clinical trial
- Participants with other serious medical conditions (such as uncontrolled hypertension, diabetes mellitus and active infections)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Anyang, South Korea
Unknown Facility
Busan, South Korea
Unknown Facility
Cheonan, South Korea
Unknown Facility
Chungcheongbuk-Do, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Daejeon, South Korea
Unknown Facility
Gyeonggi-do, South Korea
Unknown Facility
Hwasun Gun, South Korea
Unknown Facility
Iksan, South Korea
Unknown Facility
Incheon, South Korea
Unknown Facility
Jeonju, South Korea
Unknown Facility
Jinju, South Korea
Unknown Facility
Pucheon, South Korea
Unknown Facility
Pusan, South Korea
Unknown Facility
Seongnam, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Suwon, South Korea
Unknown Facility
Ulsan, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd., Korea Clinical Trial
Janssen Korea, Ltd., Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2015
First Posted
June 17, 2015
Study Start
May 1, 2011
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 30, 2015
Record last verified: 2015-06