BORTEZOMIB, LENALIDOMIDE AND DEXAMETHASONE WITH OR WITHOUT ELOTUZUMAB AS INDUCTION THERAPY FOR NEWLY-DIAGNOSED, TRANSPLANT-ELIGIBLE MULTIPLE MYELOMA
Author(s): ,
Hartmut Goldschmidt
Affiliations:
Internal Medicine V,University Hospital Heidelberg,Heidelberg,Germany;National Center for Tumor Diseases,Heidelberg,Germany
,
Elias K. Mai
Affiliations:
Internal Medicine V,University Hospital Heidelberg,Heidelberg,Germany;National Center for Tumor Diseases,Heidelberg,Germany
,
Hans Salwender
Affiliations:
Tumorzentrum Asklepios Hamburg,AK Altona and AK St. Georg,Hamburg,Germany
,
Uta Bertsch
Affiliations:
Internal Medicine V,University Hospital Heidelberg,Heidelberg,Germany;National Center for Tumor Diseases,Heidelberg,Germany
,
Kaya Miah
Affiliations:
Division of Biostatistics,German Cancer Research Center (DKFZ),Heidelberg,Germany
,
Christina Kunz
Affiliations:
Division of Biostatistics,German Cancer Research Center (DKFZ),Heidelberg,Germany;Institute of Child Nutrition,Max Rubner Institute, Federal Research Institute of Nutrition and Food,Karlsruhe,Germany
,
Roland Fenk
Affiliations:
Department of Hematology, Oncology and Clinical Immunology,University Hospital Düsseldorf,Düsseldorf,Germany
,
Igor Blau
Affiliations:
Medical Clinic,Charité University Medicine Berlin,Berlin,Germany
,
Christof Scheid
Affiliations:
Department of Internal Medicine I,University Hospital Cologne,Cologne,Germany
,
Hans Martin
Affiliations:
Medical Clinic II,University Hospital Frankfurt,Frankfurt a. M.,Germany
,
Jörg Thomalla
Affiliations:
Clinic for Hematology and Oncology,Koblenz,Germany
,
Rolf Mahlberg
Affiliations:
Internal Medicine I,Hospital Mutterhaus der Boromäerinnen,Trier,Germany
,
Marc Raab
Affiliations:
Internal Medicine V,University Hospital Heidelberg,Heidelberg,Germany
,
Stefanie Huhn
Affiliations:
Internal Medicine V,University Hospital Heidelberg,Heidelberg,Germany;National Center for Tumor Diseases,Heidelberg,Germany
,
Dirk Hose
Affiliations:
Internal Medicine V,University Hospital Heidelberg,Heidelberg,Germany
,
Anna Jauch
Affiliations:
Institute of Human Genetics,University of Heidelberg,Heidelberg,Germany
,
Ullrich Graeven
Affiliations:
Medical Clinic I,Hospital Maria Hilf GmbH,Mönchengladbach,Germany
,
Mohammed Wattad
Affiliations:
Clinic Essen Süd,Evangelisches Krankenhaus Essen-Werden,Essen,Germany
,
Britta Besemer
Affiliations:
Department of Hematology, Oncology and Immunology,University Hospital Tübingen,Tübingen,Germany
,
Andrea Seidel-Glätzer
Affiliations:
Coordination Centre for Clinical Trials (KKS) Heidelberg,Heidelberg,Germany
,
Roland Schroers
Affiliations:
University Hospital Bochum,Knappschaftskrankenhaus Bochum,Bochum,Germany
,
Andreas Neubauer
Affiliations:
Department of Hematology, Oncology and Immunology,Phillips-University Marbrug,Marburg,Germany
,
Jan Dürig
Affiliations:
Department of Hematology,University Clinic Essen,Essen,Germany
,
Markus Munder
Affiliations:
Department of Internal Medicine III,University Medical Center Mainz,Mainz,Germany
,
Mathias Hänel
Affiliations:
Department of Internal Medicine III,Klinikum Chemnitz,Chemnitz,Germany
Katja Weisel
Affiliations:
Department of Hematology, Oncology and Immunology,University Hospital Tübingen,Tübingen,Germany;Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology,University Medical Center Hamburg-Eppendorf,Hamburg,Germany
EHA Library. Goldschmidt H. 06/12/20; 295023; S203
Hartmut Goldschmidt
Hartmut Goldschmidt
Contributions
Abstract

Abstract: S203

Type: Oral Presentation

Presentation during EHA25: All oral abstract presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Session title: New insights in the treatment of newly diagnosed multiple myeloma

Background

The anti-CD38 monoclonal antibody (moAb) daratumumab has become an established component of the treatment of newly-diagnosed multiple myeloma (MM).

Aims

Comparative phase III trial data on the anti-SLAMF7 moAb elotuzumab (Elo) in newly diagnosed transplant-eligible MM have not been presented so far.

Methods

The German-speaking Myeloma Multicenter Group (GMMG) trial HD6 (NCT 02495922) is a randomized multicenter phase III treatment protocol including 559 and 555 patients in the intention-to-treat (ITT) and safety population, respectively. Induction therapy consisted of four 21-day cycles of bortezomib, lenalidomide and dexamethasone with or without elotuzumab (VRD, arms A1+A2, n=280 and Elo-VRD, arms B1+B2, n=279). Analyses on feasibility, response rates and toxicities of VRD vs. Elo-VRD induction therapy will be presented.

Results

Median age was 59 (27 - 70) years at trial inclusion. Revised International Staging System (R-ISS), ISS stages, adverse cytogenetics (at least one of the following: del17p13, t(4;14), gain 1q21 >3 copies) and the proportion of patients with renal impairment (either serum creatinine >2 mg/dl or glomerular filtration rate <40 ml/min) were equally distributed among the VRD and Elo-VRD groups.

At least four cycles of preplanned VRD or Elo-VRD induction therapy were completed by 264 (94.3%) and 258 (92.5%) patients. Until 30 days after induction therapy, 21 and 25 patients went off study in the VRD and Elo-VRD groups (including toxicity, progressive disease, death or withdrawal of consent).

The overall response rates (ORR, ≥PR) after the fourth cycle of induction therapy were 85.6% and 82.4% in the VRD vs. Elo-VRD group (p=0.35). Very good partial response rates or better (≥VGPR) were 54.0% and 58.3% in the VRD vs. Elo-VRD group (p=0.35). Rates of complete responses (CR) are currently being evaluated due to interference of the moAb elotuzumab with serum electrophoresis and immunofixation.

At least one (serious) adverse event (SAE of any grade, or AE ≥3º and infections, cardiac disorders, neuropathy and thromboembolic events ≥2º according to CTCAE, version 4.0) during induction therapy occurred in 183 patients of the safety population in either group (VRD: n=183/275, 66.5% vs. Elo-VRD: n=183/280, 65.4%, p=0.79). Most common system organ classes (SOC) were: nervous system disorders (VRD: 24.0% vs. Elo-VRD: 23.6%, p=0.92), infections and infestations (VRD: 22.9% vs. Elo-VRD: 20.0%, p=0.41) and blood and lymphatic system disorders (VRD: 8.4% vs. Elo-VRD: 14.6%, p=0.02). There were 4 and 9 deaths associated with induction therapy in the VRD and Elo-VRD group.

Conclusion

The addition of elotuzumab to VRD in newly diagnosed, transplant-eligible MM did not result in increased ≥VGPR rates after four cycles of induction therapy. Whether the addition of elotuzumab yields improved response rates at latter time points (e.g. after consolidation) or a progression-free and/or overall survival benefit needs to be elicited in the final analysis of this trial.

The GMMG-HD6 trial was funded by BMS, Celgene and Chugai.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Autologous hematopoietic stem cell transplantation, Induction chemotherapy, Myeloma

Abstract: S203

Type: Oral Presentation

Presentation during EHA25: All oral abstract presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Session title: New insights in the treatment of newly diagnosed multiple myeloma

Background

The anti-CD38 monoclonal antibody (moAb) daratumumab has become an established component of the treatment of newly-diagnosed multiple myeloma (MM).

Aims

Comparative phase III trial data on the anti-SLAMF7 moAb elotuzumab (Elo) in newly diagnosed transplant-eligible MM have not been presented so far.

Methods

The German-speaking Myeloma Multicenter Group (GMMG) trial HD6 (NCT 02495922) is a randomized multicenter phase III treatment protocol including 559 and 555 patients in the intention-to-treat (ITT) and safety population, respectively. Induction therapy consisted of four 21-day cycles of bortezomib, lenalidomide and dexamethasone with or without elotuzumab (VRD, arms A1+A2, n=280 and Elo-VRD, arms B1+B2, n=279). Analyses on feasibility, response rates and toxicities of VRD vs. Elo-VRD induction therapy will be presented.

Results

Median age was 59 (27 - 70) years at trial inclusion. Revised International Staging System (R-ISS), ISS stages, adverse cytogenetics (at least one of the following: del17p13, t(4;14), gain 1q21 >3 copies) and the proportion of patients with renal impairment (either serum creatinine >2 mg/dl or glomerular filtration rate <40 ml/min) were equally distributed among the VRD and Elo-VRD groups.

At least four cycles of preplanned VRD or Elo-VRD induction therapy were completed by 264 (94.3%) and 258 (92.5%) patients. Until 30 days after induction therapy, 21 and 25 patients went off study in the VRD and Elo-VRD groups (including toxicity, progressive disease, death or withdrawal of consent).

The overall response rates (ORR, ≥PR) after the fourth cycle of induction therapy were 85.6% and 82.4% in the VRD vs. Elo-VRD group (p=0.35). Very good partial response rates or better (≥VGPR) were 54.0% and 58.3% in the VRD vs. Elo-VRD group (p=0.35). Rates of complete responses (CR) are currently being evaluated due to interference of the moAb elotuzumab with serum electrophoresis and immunofixation.

At least one (serious) adverse event (SAE of any grade, or AE ≥3º and infections, cardiac disorders, neuropathy and thromboembolic events ≥2º according to CTCAE, version 4.0) during induction therapy occurred in 183 patients of the safety population in either group (VRD: n=183/275, 66.5% vs. Elo-VRD: n=183/280, 65.4%, p=0.79). Most common system organ classes (SOC) were: nervous system disorders (VRD: 24.0% vs. Elo-VRD: 23.6%, p=0.92), infections and infestations (VRD: 22.9% vs. Elo-VRD: 20.0%, p=0.41) and blood and lymphatic system disorders (VRD: 8.4% vs. Elo-VRD: 14.6%, p=0.02). There were 4 and 9 deaths associated with induction therapy in the VRD and Elo-VRD group.

Conclusion

The addition of elotuzumab to VRD in newly diagnosed, transplant-eligible MM did not result in increased ≥VGPR rates after four cycles of induction therapy. Whether the addition of elotuzumab yields improved response rates at latter time points (e.g. after consolidation) or a progression-free and/or overall survival benefit needs to be elicited in the final analysis of this trial.

The GMMG-HD6 trial was funded by BMS, Celgene and Chugai.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Autologous hematopoietic stem cell transplantation, Induction chemotherapy, Myeloma

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies