Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 26866138MMY4056 | Other Identifier | Janssen Korea, Ltd., Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the 2-year progression-free survival rate.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anyang | South Korea | |||||
Not provided
Not provided
Not provided
Not provided
| Melphalan | Drug | Participants receiving Melphalan 9 mg/m^2 will be observed in this study. |
|
| Prednisone | Drug | Participants receiving Prednisone 60 mg/m^2 will be observed in this study. |
|
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 |
| Busan |
| South Korea |
| Cheonan | South Korea |
| Chungcheongbuk-Do | South Korea |
| Daegu | South Korea |
| Daejeon | South Korea |
| Gyeonggi-do | South Korea |
| Hwasun Gun | South Korea |
| Iksan | South Korea |
| Incheon | South Korea |
| Jeonju | South Korea |
| Jinju | South Korea |
| Pucheon | South Korea |
| Pusan | South Korea |
| Seongnam | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| Ulsan | South Korea |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D008558 | Melphalan |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided