Clarithromycin added to bortezomib‐cyclophosphamide‐dexamethasone impairs health‐related quality of life in multiple myeloma patients

Lene Kongsgaard Nielsen*, Tobias Wirenfeldt Klausen, Mary Jarden, Henrik Frederiksen, Annette Juul Vangsted, Trung Do, Ida Bruun Kristensen, Ulf Christian Frølund, Christen Lykkegaard Andersen, Niels Abildgaard, Henrik Gregersen

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Objectives: The Danish Myeloma Study Group initiated a randomized, placebo-controlled, double-blinded phase II study to investigate the efficacy of adding clarithromycin to cyclophosphamide-bortezomib-dexamethasone (VCD) induction therapy in transplant eligible, newly diagnosed multiple myeloma patients. The study was prematurely terminated due to severe complications, and no effect of adding clarithromycin was found. The aim of this study was to compare health-related quality of life (HRQoL) between the two groups and to explore the coherence hereof with adverse event (AE) registration by clinicians. Methods: Patients completed three validated HRQoL questionnaires at inclusion, before cyclophosphamide priming, and two months after high-dose therapy (HDT). The mean score difference was interpreted by clinically relevant differences between groups. Spearman's correlation analysis was used to compare patient-reported toxicities with AEs. Results: Of 58 included patients, 55 participated in the HRQoL reporting. Before cyclophosphamide priming, patients in the clarithromycin group reported clinically relevant reduced HRQoL for eleven domains with persistent reduction in four domains two months after HDT. Poor correlation between patient-reported toxicities and clinician-reported AEs was observed. Conclusions: Despite the premature study termination, our data demonstrate impaired HRQoL when clarithromycin was added to the VCD regimen. We found clear underreporting of toxicities by clinicians. ClinicalTrials.gov number NCT02573935.

OriginalsprogEngelsk
TidsskriftEuropean Journal of Haematology
Vol/bind102
Udgave nummer1
Sider (fra-til)70-78
ISSN0902-4441
DOI
StatusUdgivet - jan. 2019

Fingeraftryk

Clarithromycin
Quality of Life
Placebos

Citer dette

Nielsen, Lene Kongsgaard ; Klausen, Tobias Wirenfeldt ; Jarden, Mary ; Frederiksen, Henrik ; Vangsted, Annette Juul ; Do, Trung ; Kristensen, Ida Bruun ; Frølund, Ulf Christian ; Andersen, Christen Lykkegaard ; Abildgaard, Niels ; Gregersen, Henrik. / Clarithromycin added to bortezomib‐cyclophosphamide‐dexamethasone impairs health‐related quality of life in multiple myeloma patients. I: European Journal of Haematology. 2019 ; Bind 102, Nr. 1. s. 70-78.
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title = "Clarithromycin added to bortezomib‐cyclophosphamide‐dexamethasone impairs health‐related quality of life in multiple myeloma patients",
abstract = "Objectives: The Danish Myeloma Study Group initiated a randomized, placebo-controlled, double-blinded phase II study to investigate the efficacy of adding clarithromycin to cyclophosphamide-bortezomib-dexamethasone (VCD) induction therapy in transplant eligible, newly diagnosed multiple myeloma patients. The study was prematurely terminated due to severe complications, and no effect of adding clarithromycin was found. The aim of this study was to compare health-related quality of life (HRQoL) between the two groups and to explore the coherence hereof with adverse event (AE) registration by clinicians. Methods: Patients completed three validated HRQoL questionnaires at inclusion, before cyclophosphamide priming, and two months after high-dose therapy (HDT). The mean score difference was interpreted by clinically relevant differences between groups. Spearman's correlation analysis was used to compare patient-reported toxicities with AEs. Results: Of 58 included patients, 55 participated in the HRQoL reporting. Before cyclophosphamide priming, patients in the clarithromycin group reported clinically relevant reduced HRQoL for eleven domains with persistent reduction in four domains two months after HDT. Poor correlation between patient-reported toxicities and clinician-reported AEs was observed. Conclusions: Despite the premature study termination, our data demonstrate impaired HRQoL when clarithromycin was added to the VCD regimen. We found clear underreporting of toxicities by clinicians. ClinicalTrials.gov number NCT02573935.",
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author = "Nielsen, {Lene Kongsgaard} and Klausen, {Tobias Wirenfeldt} and Mary Jarden and Henrik Frederiksen and Vangsted, {Annette Juul} and Trung Do and Kristensen, {Ida Bruun} and Fr{\o}lund, {Ulf Christian} and Andersen, {Christen Lykkegaard} and Niels Abildgaard and Henrik Gregersen",
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Clarithromycin added to bortezomib‐cyclophosphamide‐dexamethasone impairs health‐related quality of life in multiple myeloma patients. / Nielsen, Lene Kongsgaard; Klausen, Tobias Wirenfeldt; Jarden, Mary; Frederiksen, Henrik; Vangsted, Annette Juul; Do, Trung; Kristensen, Ida Bruun; Frølund, Ulf Christian; Andersen, Christen Lykkegaard; Abildgaard, Niels; Gregersen, Henrik.

I: European Journal of Haematology, Bind 102, Nr. 1, 01.2019, s. 70-78.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Clarithromycin added to bortezomib‐cyclophosphamide‐dexamethasone impairs health‐related quality of life in multiple myeloma patients

AU - Nielsen, Lene Kongsgaard

AU - Klausen, Tobias Wirenfeldt

AU - Jarden, Mary

AU - Frederiksen, Henrik

AU - Vangsted, Annette Juul

AU - Do, Trung

AU - Kristensen, Ida Bruun

AU - Frølund, Ulf Christian

AU - Andersen, Christen Lykkegaard

AU - Abildgaard, Niels

AU - Gregersen, Henrik

PY - 2019/1

Y1 - 2019/1

N2 - Objectives: The Danish Myeloma Study Group initiated a randomized, placebo-controlled, double-blinded phase II study to investigate the efficacy of adding clarithromycin to cyclophosphamide-bortezomib-dexamethasone (VCD) induction therapy in transplant eligible, newly diagnosed multiple myeloma patients. The study was prematurely terminated due to severe complications, and no effect of adding clarithromycin was found. The aim of this study was to compare health-related quality of life (HRQoL) between the two groups and to explore the coherence hereof with adverse event (AE) registration by clinicians. Methods: Patients completed three validated HRQoL questionnaires at inclusion, before cyclophosphamide priming, and two months after high-dose therapy (HDT). The mean score difference was interpreted by clinically relevant differences between groups. Spearman's correlation analysis was used to compare patient-reported toxicities with AEs. Results: Of 58 included patients, 55 participated in the HRQoL reporting. Before cyclophosphamide priming, patients in the clarithromycin group reported clinically relevant reduced HRQoL for eleven domains with persistent reduction in four domains two months after HDT. Poor correlation between patient-reported toxicities and clinician-reported AEs was observed. Conclusions: Despite the premature study termination, our data demonstrate impaired HRQoL when clarithromycin was added to the VCD regimen. We found clear underreporting of toxicities by clinicians. ClinicalTrials.gov number NCT02573935.

AB - Objectives: The Danish Myeloma Study Group initiated a randomized, placebo-controlled, double-blinded phase II study to investigate the efficacy of adding clarithromycin to cyclophosphamide-bortezomib-dexamethasone (VCD) induction therapy in transplant eligible, newly diagnosed multiple myeloma patients. The study was prematurely terminated due to severe complications, and no effect of adding clarithromycin was found. The aim of this study was to compare health-related quality of life (HRQoL) between the two groups and to explore the coherence hereof with adverse event (AE) registration by clinicians. Methods: Patients completed three validated HRQoL questionnaires at inclusion, before cyclophosphamide priming, and two months after high-dose therapy (HDT). The mean score difference was interpreted by clinically relevant differences between groups. Spearman's correlation analysis was used to compare patient-reported toxicities with AEs. Results: Of 58 included patients, 55 participated in the HRQoL reporting. Before cyclophosphamide priming, patients in the clarithromycin group reported clinically relevant reduced HRQoL for eleven domains with persistent reduction in four domains two months after HDT. Poor correlation between patient-reported toxicities and clinician-reported AEs was observed. Conclusions: Despite the premature study termination, our data demonstrate impaired HRQoL when clarithromycin was added to the VCD regimen. We found clear underreporting of toxicities by clinicians. ClinicalTrials.gov number NCT02573935.

KW - clinical trials

KW - multiple myeloma

KW - quality of life

KW - transplantation

U2 - 10.1111/ejh.13175

DO - 10.1111/ejh.13175

M3 - Journal article

C2 - 30230047

AN - SCOPUS:85055719744

VL - 102

SP - 70

EP - 78

JO - European Journal of Haematology

JF - European Journal of Haematology

SN - 0902-4441

IS - 1

ER -