|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Millennium Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00507416 |
Purpose
This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of VELCADE dexamethasone versus VELCADE, thalidomide, and dexamethasone versus VELCADE, melphalan, and prednisone in patients with previously untreated multiple myeloma who are not considered candidates for high-dose chemotherapy and autologous stem cell transplantation. This study will consist of a Screening period (generally 4 weeks or less), an Induction Treatment period (approximately 6 months), a Maintenance Treatment period (approximately 6 months), and a Post-treatment period.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: bortezomib, thalidomide, and dexamethasone (VTD) Drug: bortezomib and dexamethasone (VD) Drug: bortezomib, melphalan and prednisone (VMP) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone |
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bortezomib, Thalidomide, and Dexamethasone (VTD) |
Drug: bortezomib, thalidomide, and dexamethasone (VTD)
bortezomib intravenously on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8. Thalidomide orally on Days 1-21 of a 21-day cycle during Cycles 1-8. Dexamethasone orally once daily (QD) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle during Cycles 1-4 (ie, on the day of and day after bortezomib administration), and then orally QD on Days 1, 2, 4, and 5 of a 21-day cycle during Cycles 5-8 Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive bortezomib intravenously on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13. Other Name: VELCADE
|
| Experimental: Bortezomib and Dexamethasone (VD) |
Drug: bortezomib and dexamethasone (VD)
bortezomib intravenously on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8. Dexamethasone orally once daily (QD) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle during Cycles 1-4 (ie, on the day of and day after bortezomib administration), and then orally QD on Days 1, 2, 4, and 5 of a 21-day cycle during Cycles 5-8. Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive bortezomib intravenously on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13. Other Name: VELCADE
|
| Experimental: Bortezomib, melphalan, and prednisone (VMP) |
Drug: bortezomib, melphalan and prednisone (VMP)
bortezomib administered intravenously on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8. Melphalan: orally once daily (QD) on Days 1-4 every other cycle during Cycles 1-8. Prednisone:orally QD on Days 1-4 every other cycle during Cycles 1-8. Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive bortezomib intravenously on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13. Other Name: VELCADE
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 235 Study Locations| Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Clinical Study Medical Monitor, Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00507416 History of Changes |
| Other Study ID Numbers: | C05009 |
| Study First Received: | July 25, 2007 |
| Last Updated: | February 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Prednisone Dexamethasone 21-phosphate Bortezomib Melphalan Thalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |