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document
Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma : an interim analysis from the prospective GMMG-MM5 trial . We investigated the impact of subcutaneous versus intravenous bortezomib in the MM5 trial of the German-Speaking Myeloma Multicenter Group which compared bortezomib , doxorubicin , and dexamethasone with bortezomib , cyclophosphamide , and dexamethasone induction therapy in newly diagnosed multiple myeloma . Based on data from relapsed myeloma , the route of administration for bortezomib was changed from intravenous to subcutaneous after 314 of 604 patients had been enrolled . We analyzed 598 patients who received at least one dose of trial medication . Adverse events were reported more frequently in patients treated with intravenous bortezomib ( intravenous=65 % ; subcutaneous=56 % , P=0.02 ) . Rates of grade 2 or more peripheral neuropathy were higher in patients treated with intravenous bortezomib during the third cycle ( intravenous=8 % ; subcutaneous=2 % , P=0.001 ) . Overall response rates were similar in patients treated intravenously or subcutaneously . The presence of International Staging System stage III disease , renal impairment or adverse cytogenetic abnormalities did not have a negative impact on overall response rates in either group . To our knowledge this is the largest study to present data comparing subcutaneous with intravenous bortezomib in newly diagnosed myeloma . We show better tolerance and similar overall response rates for subcutaneous compared to intravenous bortezomib . The clinical trial is registered at eudract.ema.europa.eu as n. 2010-019173-16 .
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Intervention_Pharmacological
Subcutaneous versus intravenous bortezomib
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Intervention_Pharmacological
subcutaneous versus intravenous bortezomib
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Intervention_Pharmacological
bortezomib
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Intervention_Pharmacological
doxorubicin
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Intervention_Pharmacological
dexamethasone
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Intervention_Pharmacological
bortezomib
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
dexamethasone
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Outcome_Physical
Subcutaneous
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Outcome_Physical
intravenous bortezomib
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Outcome_Physical
subcutaneous
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Outcome_Physical
intravenous bortezomib
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Outcome_Adverse-effects
Adverse events
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Outcome_Other
Rates of
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Outcome_Physical
grade 2 or more peripheral neuropathy
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Outcome_Other
Overall response rates
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Outcome_Other
International Staging System stage III disease , renal impairment or adverse cytogenetic abnormalities
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Outcome_Physical
myeloma
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Outcome_Mental
tolerance
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Outcome_Other
response
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Participant_Condition
newly diagnosed multiple myeloma
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Participant_Sample-size
314 of 604 patients
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Participant_Sample-size
598 patients
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Participant_Condition
patients treated with intravenous bortezomib
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Participant_Condition
treated with intravenous bortezomib