KEYNOTE-183, 2018 trial summary

A randomised clinical trial investigating the effect of pembrolizumab + pomadoline + dexamethasone versus pomadoline + dexamethasone in refractory or relapsed and refractory Multiple Myeloma (rrMM)

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NCT02576977    



Studied treatment pembrolizumab, Pomalidomide and low-dose Dexamethasone
Control treatment Pomalidomide and low-dose Dexamethasone



Patients refractory or relapsed and refractory Multiple Myeloma (rrMM)
Group sizes125 / 124



Blindness open-design Inclusion period
Follow-up duration 7.8 mo / 8.6 mo (median) Centers
Lost to FU geographical localisation
Primary endpoint Design Parallel groups



EndpointX1N1X0N0TE95% CI PFS - 125 - 124 1,53[1,05; 2,22] OS - 125 - 124 1,61[0,91; 2,85]0,22,01,0

Links

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ClinicalTrial.gov record NCT02576977



Registering number NCT02576977 (see trial on clinicaltrials.gov)
Code Name

Comment: Due to interim data presented to the data monitoring committees (DMC), the U.S. Food and Drug Administration (FDA) halted the trials and required that all patients in the two trials be discontinued