I wonder if randomized and controlled studies exist for the following triplet therapies in Multiple Myeloma:
1) "Daratumumab, pomalidomide and dexamethasone"
2) "Carfilzomib, pomalidomide, and dexamethasone"
Regards,
Ronny
No, as far as I know !
The registration trials of Carfilzomib combination was with Len-Dex ; Car-Len-Dex (KRd) vs Len-Dex [phase 3 ASPIRE (NCT01080391) study] (Dimopoulos et al., Blood Cancer J. 2017 Apr 21;7:e554. doi: 10.1038/bcj.2017.31).
Regarding Daratumumab combinations, it was Dara-Len-Dex vs Len-Dex (POLLUX phase III trial; Dimopoulos et al., N Engl J Med 2016; 375:1319-1331_DOI: 10.1056/NEJMoa1607751) !
Only phase I-II studies exist so far for Dara-Pom-Dex & Carfilzomib-Pom-Dex in RR-MM after at least 3 lines of prior therapy with Bortezomib and Lenalidomide !
Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
Ajai Chari, et al. Blood 2017 :blood-2017-05-785246; doi: https://doi.org/10.1182/blood-2017-05-785246
Clinical Efficacy of Daratumumab, Pomalidomide and Dexamethasone in Relapsed, Refractory Myeloma Patients: Utility of Retreatment with Daratumumab Among Refractory Patients
Ajay K Nooka, Nisha Joseph, Larry H Boise, Charise Gleason, Jonathan L. Kaufman and Sagar Lonial Blood 2016 128:492;
Blood. 2015 Nov 12; 126(20): 2284–2290.
Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma
Shah et al.
There is indeed a phase III study entitled: "Comparison of Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide and a Proteasome Inhibitor Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14)" - (see also https://clinicaltrials.gov/ct2/show/NCT03180736), conducted by the European Myeloma Network, that is currently accruing.