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DSMM XI study: dose definition for intravenous cyclophosphamide in combination with bortezomib/dexamethasone for remission induction in patients with newly diagnosed myeloma.
- Source :
-
Annals of hematology [Ann Hematol] 2009 Nov; Vol. 88 (11), pp. 1125-30. Date of Electronic Publication: 2009 Mar 10. - Publication Year :
- 2009
-
Abstract
- A clinical trial was initiated to evaluate the recommended dose of cyclophosphamide in combination with bortezomib and dexamethasone as induction treatment before stem cell transplantation for younger patients with newly diagnosed multiple myeloma (MM). Thirty patients were treated with three 21-day cycles of bortezomib 1.3 mg/m(2) on days 1, 4, 8, and 11 plus dexamethasone 40 mg on the day of bortezomib injection and the day after plus cyclophosphamide at 900, 1,200, or 1,500 mg/m(2) on day 1. The maximum tolerated dose of cyclophosphamide was defined as 900 mg/m(2). At this dose level, 92% of patients achieved at least a partial response. The overall response rate [complete response (CR) plus partial response (PR)] across all dose levels was 77%, with a 10% CR rate. No patient experienced progressive disease. The most frequent adverse events were hematological and gastrointestinal toxicities as well as neuropathy. The results suggest that bortezomib in combination with cyclophosphamide at 900 mg/m(2) and dexamethasone is an effective induction treatment for patients with newly diagnosed MM that warrants further investigation.
- Subjects :
- Adult
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Boronic Acids administration & dosage
Boronic Acids adverse effects
Bortezomib
Combined Modality Therapy
Cyclophosphamide administration & dosage
Cyclophosphamide adverse effects
Dexamethasone administration & dosage
Dexamethasone adverse effects
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Gastrointestinal Diseases chemically induced
Hematologic Diseases chemically induced
Hematopoietic Stem Cell Transplantation
Humans
Infusions, Intravenous
Male
Maximum Tolerated Dose
Middle Aged
Multiple Myeloma radiotherapy
Multiple Myeloma surgery
Nervous System Diseases chemically induced
Prospective Studies
Protease Inhibitors administration & dosage
Protease Inhibitors adverse effects
Pyrazines administration & dosage
Pyrazines adverse effects
Remission Induction
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Multiple Myeloma drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1432-0584
- Volume :
- 88
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Annals of hematology
- Publication Type :
- Academic Journal
- Accession number :
- 19274460
- Full Text :
- https://doi.org/10.1007/s00277-009-0726-6