Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Bortezomib, Melphalan, Prednisone
Brief summary
The purpose of this study is to assess the 2-year progression-free survival rate.
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.
Interventions
DRUGMelphalan
Participants receiving Melphalan 9 mg/m\^2 will be observed in this study.
DRUGBortezomib
Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.
DRUGPrednisone
Participants receiving Prednisone 60 mg/m\^2 will be observed in this study.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Progression-free Survival Rate | Up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Response | up to 2 years | 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. |
| Overall Response Rate | up to 2 years | Percentage of participants who achieved CR, VGPR or PR in 2 years. |
| Complete Response Rate | up to 2 years | Percentage of participants who achieved CR as best response. |
| Time to Next therapy | up to 2 years | 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. |
| Time to Disease Progression | up to 2 years | Time from the first day of Bortezomib administration to the day of disease progression or relapse from complete response, whichever comes first. |
Countries
South Korea
Outcome results
None listed