Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma.
Adult
Aged
Antibodies, Monoclonal, Humanized
/ administration & dosage
Bortezomib
/ administration & dosage
Consolidation Chemotherapy
Dexamethasone
/ administration & dosage
Female
Hematopoietic Stem Cell Transplantation
Humans
Induction Chemotherapy
Lenalidomide
/ administration & dosage
Maintenance Chemotherapy
Male
Melphalan
/ administration & dosage
Middle Aged
Multiple Myeloma
/ therapy
Prospective Studies
Quality of Life
Research Design
Survival Analysis
Treatment Outcome
Young Adult
Multiple myeloma
autologous stem cell transplant
elotuzumab
high-dose chemotherapy
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
28 May 2019
28 May 2019
Historique:
received:
07
02
2018
accepted:
12
04
2019
entrez:
30
5
2019
pubmed:
30
5
2019
medline:
26
11
2019
Statut:
epublish
Résumé
Despite major advances in therapy, multiple myeloma is still an incurable malignancy in the majority of patients. To increase survival, deeper remissions (i.e. CR) translating into longer PFS need to be achieved. Incorporation of new drugs (i.e. bortezomib and lenalidomide) as induction and maintenance treatment in an intensified treatment concept, including high dose melphalan (200 mg/m GMMG-HD6 is a randomized, open, multicenter phase III trial. The planned recruitment number is 564 NDMM patients. All patients will receive 4 VRD cycles as induction and undergo peripheral blood stem cell mobilization and harvesting. Thereafter they will be treated with high dose melphalan therapy plus autologous stem cell transplantation followed by 2 cycles of VRD consolidation and lenalidomide maintenance. Patients in arm B1 + B2 will additionally receive elotuzumab in the induction phase, whereas patients in A2 + B2 will be treated with elotuzumab added to consolidation and maintenance. The primary endpoint of the trial is PFS. Secondary objectives and endpoints are OS, CR rates after induction therapy comparing the two arms VRD (A1 + A2) vs VRD + elotuzumab (B1 + B2), CR rates after consolidation treatment, best response to treatment during the study, time to progression (TTP), duration of response (DOR), toxicity and quality of life. Since this is the publication of a study protocol of an ongoing study, no results can be presented. This phase III trial is designed to evaluate whether the addition of elotuzumab to an intensified treatment concept with high dose melphalan chemotherapy plus autologous stem cell transplantation and induction, consolidation and maintenance treatment with bortezomib and lenalidomide is able to improve PFS compared to the same concept without elotuzumab. NCT02495922 on June 24th, 2015.
Sections du résumé
BACKGROUND
BACKGROUND
Despite major advances in therapy, multiple myeloma is still an incurable malignancy in the majority of patients. To increase survival, deeper remissions (i.e. CR) translating into longer PFS need to be achieved. Incorporation of new drugs (i.e. bortezomib and lenalidomide) as induction and maintenance treatment in an intensified treatment concept, including high dose melphalan (200 mg/m
METHODS
METHODS
GMMG-HD6 is a randomized, open, multicenter phase III trial. The planned recruitment number is 564 NDMM patients. All patients will receive 4 VRD cycles as induction and undergo peripheral blood stem cell mobilization and harvesting. Thereafter they will be treated with high dose melphalan therapy plus autologous stem cell transplantation followed by 2 cycles of VRD consolidation and lenalidomide maintenance. Patients in arm B1 + B2 will additionally receive elotuzumab in the induction phase, whereas patients in A2 + B2 will be treated with elotuzumab added to consolidation and maintenance. The primary endpoint of the trial is PFS. Secondary objectives and endpoints are OS, CR rates after induction therapy comparing the two arms VRD (A1 + A2) vs VRD + elotuzumab (B1 + B2), CR rates after consolidation treatment, best response to treatment during the study, time to progression (TTP), duration of response (DOR), toxicity and quality of life.
RESULTS
RESULTS
Since this is the publication of a study protocol of an ongoing study, no results can be presented.
DISCUSSION
CONCLUSIONS
This phase III trial is designed to evaluate whether the addition of elotuzumab to an intensified treatment concept with high dose melphalan chemotherapy plus autologous stem cell transplantation and induction, consolidation and maintenance treatment with bortezomib and lenalidomide is able to improve PFS compared to the same concept without elotuzumab.
TRIAL REGISTRATION
BACKGROUND
NCT02495922 on June 24th, 2015.
Identifiants
pubmed: 31138244
doi: 10.1186/s12885-019-5600-x
pii: 10.1186/s12885-019-5600-x
pmc: PMC6537200
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
elotuzumab
1351PE5UGS
Bortezomib
69G8BD63PP
Dexamethasone
7S5I7G3JQL
Lenalidomide
F0P408N6V4
Melphalan
Q41OR9510P
Banques de données
ClinicalTrials.gov
['NCT02495922']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
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