Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma

Study Overview
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Brief Summary
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The purpose of this study is to assess the 2-year progression-free survival rate.

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Bortezomib
* Drug: Melphalan
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bortezomib, Melphalan, Prednisone (VMP) Group<br>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. | Drug: Bortezomib<br>* Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.<br>Drug: Melphalan<br>* Participants receiving Melphalan 9 mg/m^2 will be observed in this study.<br>Drug: Prednisone<br>* Participants receiving Prednisone 60 mg/m^2 will be observed in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Response | 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. | up to 2 years | 
| Overall Response Rate | Percentage of participants who achieved CR, VGPR or PR in 2 years. | up to 2 years | 
| Complete Response Rate | Percentage of participants who achieved CR as best response. | up to 2 years | 
| Time to Next therapy | 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. | up to 2 years | 
| Time to Disease Progression | Time from the first day of Bortezomib administration to the day of disease progression or relapse from complete response, whichever comes first. | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Bortezomib, Melphalan, Prednisone