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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 3 |
| Study Type: | Expanded Access What is Expanded Access? |
| 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 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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: | May 3, 2012 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
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Prednisone Bortezomib Melphalan |
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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 |