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| Sponsor: | Janssen-Ortho Inc., Canada |
|---|---|
| Collaborator: |
Ortho Biotech Canada |
| Information provided by: | Janssen-Ortho Inc., Canada |
| ClinicalTrials.gov Identifier: | NCT00799539 |
Purpose
The primary reason for this study is to further assess safety and efficacy data of the bortezomib/melphalan/prednisone (BMP) regimen in previously untreated and transplant ineligible multiple myeloma patients
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: bortezomib Drug: prednisone Drug: melphalan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Safety/Efficacy Study |
| Official Title: | An International Single-Arm Study to Provide Further Safety and Efficacy Data on the Bortezomib(Velcade)/Melphalan/Prednisone Regimen in Previously Untreated Transplant Ineligible Multiple Myeloma Patients |
| Enrollment: | 5 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 001: Experimental |
Drug: bortezomib
From cycles 5-9, 1.3mg/m^2 on days 1, 8, 22, and 29 of each 6-week cycle
Drug: bortezomib
From cycles 1-4, 1.3mg/m^2 on days 1,4,8,11,22,25,29,and 32 of each 6-week cycle
|
| 002 |
Drug: prednisone
60 mg/m^2 once daily on days 1-4 of each 6-week cycle
Drug: melphalan
9 mg/m^2 once daily on days 1-4 of each 6-week cycle
|
Show Detailed Description
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
More Information
| Responsible Party: | Janssen-Ortho Inc., Canada ( VP, Medical & Government Affairs ) |
| Study ID Numbers: | CR015310, 26866138MMY3020 |
| Study First Received: | November 26, 2008 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00799539 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Bortezomib Melphalan Prednisone |
|
Anti-Inflammatory Agents Melphalan Prednisone Molecular Mechanisms of Pharmacological Action Immunologic Factors Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases |
Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Vascular Diseases Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms |