GMMG HD7 is a randomized phase three trial with two independent significant endpoints and in the first part of the trial we compared triplet induction consisting of bortezomib, lenalidomide and dexamethasone to a quadruplet induction therapy adding isatuximab to VRD, followed by transplant, and then followed by the second part of the study where we randomize lenalidomide against isatuximab plus lenalidomide...
GMMG HD7 is a randomized phase three trial with two independent significant endpoints and in the first part of the trial we compared triplet induction consisting of bortezomib, lenalidomide and dexamethasone to a quadruplet induction therapy adding isatuximab to VRD, followed by transplant, and then followed by the second part of the study where we randomize lenalidomide against isatuximab plus lenalidomide. And the results of the first part have been presented last year here at ASH and have been published in the JCO. And this year, we look at the health-related quality of life of the patients during this first part and during the induction treatment. And what we found is that the addition of isatuximab does not negatively influence the health-related quality of life. It even led to a faster reduction of pain and fatigue in the patients that received the quadruplet as compared to the triplet. And the overall health-related quality of life was similar.
When we then looked into other items like the future perspective of the patients, we could even find significant differences between these two groups favoring the quadruplet arms. So patients receiving ISA-RVd had a more positive view on their future perspective with regards to the disease. In my opinion, it’s just highlighting the efficacy of these drugs in the front line and that the addition of isatuximab to RVd does not in any way diminish the quality of life of the patient. So we are happy with the results and we think this underscores that the treatment is not just efficacious but that it’s also safe and very well tolerated by the patients.
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