Trials / Completed
CompletedNCT01818752
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 955 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Carfilzomib | Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1. |
| DRUG | Bortezomib | Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9. |
| DRUG | Melphalan | Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles. |
| DRUG | Prednisone | Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles. |
Timeline
- Start date
- 2013-07-08
- Primary completion
- 2016-07-15
- Completion
- 2016-11-04
- First posted
- 2013-03-26
- Last updated
- 2019-08-26
- Results posted
- 2017-08-01
Locations
213 sites across 30 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01818752. Inclusion in this directory is not an endorsement.