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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: melphalan Drug: prednisone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 001
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
|
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
Drug: bortezomib
From cycles 5-9, 1.3mg/m^2 on days 1, 8, 22, and 29 of each 6-week cycle
|
|
002
bortezomib From cycles 5-9, 1.3mg/m^2 on days 1, 8, 22, and 29 of each 6-week cycle
|
Drug: melphalan
9 mg/m^2 once daily on days 1-4 of each 6-week cycle
Drug: prednisone
60 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: | VP, Medical & Government Affairs, Janssen-Ortho Inc., Canada |
| ClinicalTrials.gov Identifier: | NCT00799539 History of Changes |
| Other Study ID Numbers: | CR015310, 26866138MMY3020 |
| Study First Received: | November 26, 2008 |
| Last Updated: | August 12, 2010 |
| Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada |
|
Prednisone Bortezomib Melphalan |
|
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 Melphalan |
Bortezomib Prednisone Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |