Trials / Completed
CompletedNCT02474563
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 171 (actual)
- Sponsor
- Janssen Korea, Ltd., Korea · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bortezomib | Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study. |
| DRUG | Melphalan | Participants receiving Melphalan 9 mg/m\^2 will be observed in this study. |
| DRUG | Prednisone | Participants receiving Prednisone 60 mg/m\^2 will be observed in this study. |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2014-05-01
- Completion
- 2014-05-01
- First posted
- 2015-06-17
- Last updated
- 2015-06-30
Locations
18 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02474563. Inclusion in this directory is not an endorsement.