drugset / Trial / NCT00985959
A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).
Timeline
- Start
- 2008-07
- Primary completion
- 2010-06
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JNJ-26866138 | Unknown | 0.7 mg/m2 | Intravenous |
| Subject | JNJ-26866138 | Unknown | 1 mg/m2 | Intravenous |
| Subject | JNJ-26866138 | Unknown | 1.3 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 9 mg/m2 | Oral |
| Background | Prednisolone | Other / unclassified | 60 mg/m2 | Oral |