- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02474563
Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma
June 26, 2015 updated by: Janssen Korea, Ltd., Korea
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
The purpose of this study is to assess the 2-year progression-free survival rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a prospective, open-label, multicenter, observational study.
Participants who received bortezomib, Melphalan, Prednisone(VMP) therapy for Multiple myeloma (MM) that was not eligible for autologous stem cell transplantation will be enrolled in the study.
The study will consist of Screening phase; VMP therapy phase (9cycles); Follow-up phase (2 years from the day when the first cycle was started).
Participants visited each institution for evaluation for 2 years from the date of baseline evaluation and first VMP administration (duration of treatment, 9 cycles; follow-up visits, every 3 months after the end of the treatment).
Participants receiving VMP therapy will be primarily evaluated for 2-year progression-free survival rate.
Participants safety will be monitored throughout the study.
Study Type
Observational
Enrollment (Actual)
171
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Anyang, Korea, Republic of
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Busan, Korea, Republic of
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Cheonan, Korea, Republic of
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Cheonan City, Korea, Republic of
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Chungcheongbuk-Do, Korea, Republic of
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Dae-Gu, Korea, Republic of
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Daegu, Korea, Republic of
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Daejeon, Korea, Republic of
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Daejon, Korea, Republic of
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Gyeonggi-Do, Korea, Republic of
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Hwasun Gun, Korea, Republic of
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Iksan, Korea, Republic of
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Incheon, Korea, Republic of
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Jeonju-Si, Korea, Republic of
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Jinju-Si, Korea, Republic of
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Pucheon, Korea, Republic of
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Pusan, Korea, Republic of
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Seongnam, Korea, Republic of
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Seoul, Korea, Republic of
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Suwon, Korea, Republic of
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Ulsan, Korea, Republic of
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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2-year Progression-free Survival Rate
Time Frame: Up to 2 years
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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.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Response
Time Frame: up to 2 years
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Time from the first day of Bortezomib administration to the day of confirmed first response in participants with confirmed response, or to the day of loss to follow-up, disease progression, death or completion of study therapy in participants without response.
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up to 2 years
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Overall Response Rate
Time Frame: up to 2 years
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Percentage of participants who achieved CR, VGPR or PR in 2 years.
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up to 2 years
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Complete Response Rate
Time Frame: up to 2 years
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Percentage of participants who achieved CR as best response.
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up to 2 years
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Time to Next therapy
Time Frame: up to 2 years
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The next therapy after the end of the study therapy was investigated, and the time from the day when the first therapy was started to the day when the next therapy was started was calculated.
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up to 2 years
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Time to Disease Progression
Time Frame: up to 2 years
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Time from the first day of Bortezomib administration to the day of disease progression or relapse from complete response, whichever comes first.
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up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
June 15, 2015
First Submitted That Met QC Criteria
June 15, 2015
First Posted (Estimate)
June 17, 2015
Study Record Updates
Last Update Posted (Estimate)
June 30, 2015
Last Update Submitted That Met QC Criteria
June 26, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Prednisone
- Melphalan
- Bortezomib
Other Study ID Numbers
- CR018445
- 26866138MMY4056 (Other Identifier: Janssen Korea, Ltd., Korea)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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