EMN14/54767414MMY3013 (APOLLO) (R/R)
A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma (MM) Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor (APOLLO)
- Experimental arm: daratumumab + pomalidomide + dexamethasone
- Standard arm: pomalidomide + dexamethasone
- Age 18 years or older
- Subjects must have measurable disease of MM
- Subjects must have received prior antimyeloma treatment. The prior treatment must have included both a proteasome inhibitor- and lenalidomide-containing regimens. The subject must have had a response.
- Subjects must have documented evidence of progressive disease (PD) based on the investigator's determination of response as defined by the modified IMWG criteria on or after the last regimen.
- Subjects who received only 1 line of prior treatment must have demonstrated PD on or within 60 days of completion of the lenalidomide containing regimen (ie, lenalidomide refractory).
- ECOG 0-2
- Previous therapy with any anti-CD38 monoclonal antibody
- Previous exposure to pomalidomide
- Subject has received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization.
- Previous allogenic stem cell transplant; or autologous stem cell transplantation (ASCT) within 12 weeks before C1D1.
- Institut Jules Bordet
- CHU UCL Namur - site Mont-Godinne