DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Newly Diagnosed Trials

For newly diagnosed, transplant-ineligible multiple myeloma, PLEIADES trial evaluated efficacy and safety of DARZALEX FASPRO^® + VMP¹

A multicohort, open-label trial (n=67)¹

Primary endpoint in the DVMP arm: overall response rate (ORR).¹

DVMP=DARZALEX FASPRO^® (D) + bortezomib (V) + melphalan (M) + prednisone (P); PD=progressive disease; QW=once weekly; Q3W=every 3 weeks; Q4W=every 4 weeks.

Patient characteristics

DVMP: eligible patients were required to have newly diagnosed multiple myeloma who are ineligible for transplant. The median age was 75 years old (range: 66–86 years): 46% were male; 69% were White, 8% Asian, and 2% Black or African American; 33% had International Staging System (ISS) Stage I, 45% had ISS Stage II, and 22% had ISS Stage III disease¹

DARZALEX FASPRO^® + VMP demonstrated a clinical response in newly diagnosed multiple myeloma¹

In the PLEIADES trial, the primary endpoint in DARZALEX FASPRO^® + bortezomib, melphalan, and prednisone arm was overall response rate (ORR).¹

CI=confidence interval; CR=complete response; DVMP=DARZALEX FASPRO^® (D) + bortezomib (V) + melphalan (M) + prednisone (P); ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.

*Based on treated subjects.

^†DVMP (95% CI: 78-95).

Safety profile for DARZALEX FASPRO^® + VMP

Adverse reactions (≥10%) in patients receiving DARZALEX FASPRO^® in combination with bortezomib, melphalan, and prednisone.¹

VMP=bortezomib (V) + melphalan (M) + prednisone (P).

^aUpper respiratory tract infection includes nasopharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, tonsillitis, upper respiratory tract infection, and viral pharyngitis.

^bPneumonia includes lower respiratory tract infection, lung infection, pneumocystis jirovecii pneumonia, pneumonia, and pneumonia bacterial.

^cAbdominal pain includes abdominal pain and abdominal pain upper.

^dFatigue includes asthenia and fatigue.

^eEdema peripheral includes edema, edema peripheral, and peripheral swelling.

^fCough includes cough and productive cough.

^gOnly Grade 3 adverse reactions occurred.

The most common adverse reactions (≥20%) were upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain.¹

Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO^® combination therapy¹