DSMM XI study: dose definition for intravenous cyclophosphamide in combination with bortezomib/dexamethasone for remission induction in patients with newly diagnosed myeloma
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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. / Kropff, Martin; Liebisch, Peter; Knop, Stefan; Weisel, Katja; Wand, Hannes; Gann, Claudia-Nanette; Berdel, Wolfgang E; Einsele, Herrmann; Deutsche Studiengruppe Multiples Myelom, DSMM.
in: ANN HEMATOL, Jahrgang 88, Nr. 11, 11.2009, S. 1125-30.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - DSMM XI study: dose definition for intravenous cyclophosphamide in combination with bortezomib/dexamethasone for remission induction in patients with newly diagnosed myeloma
AU - Kropff, Martin
AU - Liebisch, Peter
AU - Knop, Stefan
AU - Weisel, Katja
AU - Wand, Hannes
AU - Gann, Claudia-Nanette
AU - Berdel, Wolfgang E
AU - Einsele, Herrmann
AU - Deutsche Studiengruppe Multiples Myelom, DSMM
PY - 2009/11
Y1 - 2009/11
N2 - 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.
AB - 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.
KW - Adult
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Boronic Acids
KW - Bortezomib
KW - Combined Modality Therapy
KW - Cyclophosphamide
KW - Dexamethasone
KW - Dose-Response Relationship, Drug
KW - Drug Administration Schedule
KW - Female
KW - Gastrointestinal Diseases
KW - Hematologic Diseases
KW - Hematopoietic Stem Cell Transplantation
KW - Humans
KW - Infusions, Intravenous
KW - Male
KW - Maximum Tolerated Dose
KW - Middle Aged
KW - Multiple Myeloma
KW - Nervous System Diseases
KW - Prospective Studies
KW - Protease Inhibitors
KW - Pyrazines
KW - Remission Induction
KW - Clinical Trial
KW - Journal Article
KW - Multicenter Study
U2 - 10.1007/s00277-009-0726-6
DO - 10.1007/s00277-009-0726-6
M3 - SCORING: Journal article
C2 - 19274460
VL - 88
SP - 1125
EP - 1130
JO - ANN HEMATOL
JF - ANN HEMATOL
SN - 0939-5555
IS - 11
ER -