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Daratumumab Plus Cybord For Patients With Newly Diagnosed AL Amyloidosis: Safety Run-In Results Of ANDROMEDA

Daratumumab Plus Cybord For Patients With Newly Diagnosed AL Amyloidosis: Safety Run-In Results Of ANDROMEDA

In the July 2, 2020 addition of the journal Blood, investigators reported on utility of daratumumab plus CyBorD for patients with newly diagnosed light chain amyloidosis in the ANDROMEDA trial.  Given the strong efficacy data of daratumumab in multiple myeloma, investigators organized the phase 3 trial, evaluating the addition of daratumumab to CyBorD versus CyBorD in newly diagnosed light chain amyloidosis. 

A 28 patient safety run -in is reported in this trial.  Subcutaneous daratumumab was administered weekly in cycles 1-2 and then every 2 weeks in cycles 3-6 every 4 weeks thereafter for up to 2 years.  CyBorD was given weekly for 6 cycles.  A median of 2 organs were involved for patients in the trial, 68% with kidney and 61% with heart involvement.  Patients received a median of 16 treatment cycles.  Treatment emergent adverse events were consistent with the subcutaneous daratumumab utilized in multiple myeloma studies as well as CyBorD, historically. One patient had an infusion related reaction.  No grade 5 treatment emergent adverse events occurred.  5 patients died, including 3 after transplant.  Overall hematologic response rate was 96%, with a complete hematologic response in 54% of patients, n=15 patients.  At least a partial response occurred in 20, 22 and 17 patients at 1, 3 and 6 months, respectively.  Renal response occurred in 6 of 16, 7 of 15 and 10 of 15 patients while cardiac response occurred in the 6 of 16, 6 of 13 and 8 of 13 patients at 3, 6 and 12 months, respectively.  Hepatic response occurred in 2 of 3 patients at 1 year.  

The authors concluded “daratumumab plus CyBorD was well-tolerated, with no new safety concerns versus the intravenous formulation and demonstrated robust hematologic and organ responses.”

https://ashpublications.org/Blood/article/136/1/71/454281/Daratumumab-plus-CyBorD-for-patients-with-newly

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