Trials / Completed
CompletedNCT02811978
Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma
A Phase 3, Randomized, Open-label Study of Subcutaneous and Intravenous VELCADE in Combination With Dexamethasone in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to intravenous velcade when administered in combination with low-dose dexamethasone in chinese refractory or relapsed multiple myeloma (r/rMM) patients. The study will assess the overall response rate after 4 cycles of velcade and dexamethasone administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bortezomib | Participants will receive 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of a 3 week cycle. |
| DRUG | Dexamethasone | Participants will receive Dexamethasone at a dose of 20 mg PO on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle). |
Timeline
- Start date
- 2016-09-27
- Primary completion
- 2018-05-07
- Completion
- 2018-11-10
- First posted
- 2016-06-23
- Last updated
- 2019-11-08
Locations
10 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02811978. Inclusion in this directory is not an endorsement.