DARATUMUMAB SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA
Author(s):
Darko Katalinic
Affiliations:
Depatment of Internal Medicine,Faculty of Medicine, J.J. Strossmayer University of Osijek,Osijek,Croatia
(Abstract release date: 05/18/17) EHA Library. Katalinic D. 05/18/17; 181060; E1284
Dr. Darko Katalinic
Dr. Darko Katalinic
Contributions
Abstract

Abstract: E1284

Type: Eposter Presentation

Background
Daratumumab is a human IgG1k monoclonal antibody which binds with high affinity to the CD38 molecule on the surface of multiple myeloma cells. It induces rapid tumor cell death through multiple immune-mediated mechanisms and showed encouraging results alone and with lenalidomide and dexamethasone in a phase 1-2 study involving patients with relapsed multiple myeloma.

Aims
The primary end point of the study was progression-free survival.

Methods
We enrolled a total of 134 patients (74 male and 60 feemale, mean age 65.4±18.2 years) with multiple myeloma who had received at least three lines of therapy to receive lenalidomide with dexamethasone (68 patients, control group A) or in combination with daratumumab (66 patients, therapy group B).

Results
At a median follow-up of 9.8 months in a protocol-specified interim analysis, 67 patients had disease progression or death were observed (in 18 of 66 patients (27.2 %) in the group B vs. 28 of 68 (41.1%) in the control group (p<0.001)). A significantly higher rate of overall response was observed in the group B than in the group A (88.7% vs. 62.9%, p<0.001), as was a higher rate of complete response or better (39.2% vs. 16.1%, p<0.001). The most common adverse events during the treatment was myelotoxicity (neutropenia in 68.6% of the patients in the therapy group B vs. 42.1% of those in the control group A), anemia (in 21.5% vs. 13.6%) and thrombocytopenia (in 13.8% vs. 8.7%).

Conclusion
In patients with relapsed multiple myeloma, the addition of daratumumab to lenalidomide and dexamethasone appeared active and resulted in significantly improved progression-free survival. However it was associated with a higher risk of myelotoxicity.

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

Keyword(s): Relapse, Progression, Myeloma, Dexamethasone

Abstract: E1284

Type: Eposter Presentation

Background
Daratumumab is a human IgG1k monoclonal antibody which binds with high affinity to the CD38 molecule on the surface of multiple myeloma cells. It induces rapid tumor cell death through multiple immune-mediated mechanisms and showed encouraging results alone and with lenalidomide and dexamethasone in a phase 1-2 study involving patients with relapsed multiple myeloma.

Aims
The primary end point of the study was progression-free survival.

Methods
We enrolled a total of 134 patients (74 male and 60 feemale, mean age 65.4±18.2 years) with multiple myeloma who had received at least three lines of therapy to receive lenalidomide with dexamethasone (68 patients, control group A) or in combination with daratumumab (66 patients, therapy group B).

Results
At a median follow-up of 9.8 months in a protocol-specified interim analysis, 67 patients had disease progression or death were observed (in 18 of 66 patients (27.2 %) in the group B vs. 28 of 68 (41.1%) in the control group (p<0.001)). A significantly higher rate of overall response was observed in the group B than in the group A (88.7% vs. 62.9%, p<0.001), as was a higher rate of complete response or better (39.2% vs. 16.1%, p<0.001). The most common adverse events during the treatment was myelotoxicity (neutropenia in 68.6% of the patients in the therapy group B vs. 42.1% of those in the control group A), anemia (in 21.5% vs. 13.6%) and thrombocytopenia (in 13.8% vs. 8.7%).

Conclusion
In patients with relapsed multiple myeloma, the addition of daratumumab to lenalidomide and dexamethasone appeared active and resulted in significantly improved progression-free survival. However it was associated with a higher risk of myelotoxicity.

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

Keyword(s): Relapse, Progression, Myeloma, Dexamethasone

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