For relapsed or refractory multiple myeloma, after 1 prior therapy, PLEIADES trial evaluated efficacy and safety of DARZALEX FASPRO® + Rd1
A multicohort, open-label trial (n=65)1
Primary endpoint in the DRd arm: overall response rate (ORR).1
BMI=body mass index; DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); PD=progressive disease; QW=once weekly; Q2W=every 2 weeks; Q4W=every 4 weeks.
Patient characteristics
- DRd: the median age of patients was 69 years old (range: 33-82 years); 69% were male; 69% were White, and 3% were Black or African American. Forty-two percent had International Staging System (ISS) Stage I, 30% had ISS Stage II, and 28% had ISS Stage III disease. Patients had received a median of 1 prior line of therapy: 52% had a prior autologous stem-cell transplant (ASCT); 95% had received a prior proteasome inhibitor (PI); 59% had received a prior immunomodulatory agent, including 22% who received prior lenalidomide; and 54% of patients received both a prior PI and an immunomodulatory agent1
DARZALEX FASPRO® + Rd demonstrated a clinical response in relapsed or refractory multiple myeloma1
In the PLEIADES trial, the primary endpoint in DARZALEX FASPRO® + lenalidomide and dexamethasone arm was overall response rate (ORR).1
CI=confidence interval; CR=complete response; DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
*Based on treated subjects.
†DRd (95% CI: 81-97).
Safety profile for DARZALEX FASPRO® + Rd
Adverse reactions (≥10%) in patients receiving DARZALEX FASPRO® in combination with lenalidomide and dexamethasone.1
Rd=lenalidomide (R) + dexamethasone (d).
aFatigue includes asthenia and fatigue.
bUpper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection viral, rhinitis, sinusitis, upper respiratory tract infection and upper respiratory tract infection bacterial.
cPneumonia includes lower respiratory tract infection, lung infection and pneumonia.
dBronchitis includes bronchitis and bronchitis viral.
eDyspnea includes dyspnea and dyspnea exertional.
fCough includes cough and productive cough.
gOnly Grade 3 adverse reactions occurred.
The most common adverse reactions (≥20%) were fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia and dyspnea.1
Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO® combination therapy1
DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).
aDenominator is based on the safety population treated with DRd (n=65).
For relapsed or refractory multiple myeloma, after 1 to 3 prior therapies, PLEIADES trial evaluated efficacy and safety of DARZALEX FASPRO® + Kd1
A phase 2, multicohort, open-label trial (n=66)1
Primary endpoint in the DKd arm: overall response rate (ORR).1
BMI=body mass index; DKd=DARZALEX FASPRO® (D) + carfilzomib (K) + dexamethasone (d); PD=progressive disease; QW=once weekly; Q2W=every 2 weeks; Q4W=every 4 weeks.
Patient characteristics
DKd: the median age of patients was 61 years old (range: 42-84 years); 52% were male; 73% were White, and 3% were Black or African American. Sixty-eight percent had International Staging System (ISS) Stage I, 18% had ISS Stage II, and 14% had ISS Stage III disease. All patients received 1 prior line of therapy with exposure to lenalidomide and 62% of patients were refractory to lenalidomide. Seventy-nine percent had a prior autologous stem-cell transplant (ASCT).1
DARZALEX FASPRO® + Kd demonstrated a clinical response in relapsed or refractory multiple myeloma1
In the PLEIADES trial, the primary endpoint in DARZALEX FASPRO® + carfilzomib and dexamethasone arm was overall response rate (ORR).1
CI=confidence interval; CR=complete response; DKd=DARZALEX FASPRO® (D) + carfilzomib (K) + dexamethasone (d); ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
*Based on treated subjects.
†DKd (95% CI: 74-93).
Safety profile for DARZALEX FASPRO® + Kd
Adverse reactions (≥10%) in patients receiving DARZALEX FASPRO® in combination with carfilzomib and dexamethasone.1
Kd=carfilzomib (K) + dexamethasone (d).
aUpper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, viral pharyngitis and viral upper respiratory tract infection.
bBronchitis includes bronchitis and bronchitis viral.
cFatigue includes asthenia and fatigue.
dEdema peripheral includes generalized edema, edema peripheral and peripheral swelling.
eHypertension includes blood pressure increased and hypertension.
fCough includes cough and productive cough.
gDyspnea includes dyspnea and dyspnea exertional.
hOnly Grade 3 adverse reactions occurred.
Clinically relevant adverse reactions in <10% of patients who received DARZALEX FASPRO® with carfilzomib and dexamethasone include1:
- Gastrointestinal disorders: abdominal pain, constipation, pancreatitis
- Infection and infestations: pneumonia, influenza, urinary tract infection, herpes zoster, sepsis
- Metabolism and nutrition disorders: hyperglycemia, decreased appetite, hypocalcemia
- Musculoskeletal and connective tissue disorders: muscle spasms, arthralgia
- Nervous system disorders: paresthesia, dizziness, syncope
- General disorders and administration site conditions: injection site reaction, infusion reactions, chills
- Skin and subcutaneous tissue disorders: rash, pruritus
- Cardiac disorders: cardiac failure
- Vascular disorders: hypotension
Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO® combination therapy1
DKd=DARZALEX FASPRO® (D) + carfilzomib (K) + dexamethasone (d); Kd=carfilzomib (K) + dexamethasone (d).
aDenominator is based on the safety population treated with DKd (n=66).
For relapsed or refractory multiple myeloma, after 1 prior therapy, APOLLO trial evaluated efficacy and safety of DARZALEX FASPRO® + Pd1
An open-label, randomized, active-controlled trial1
Primary endpoint was progression-free survival (PFS).1
DPd=DARZALEX FASPRO® (D) + pomalidomide (P) + dexamethasone (d); PD=progressive disease; Pd=pomalidomide (P) + dexamethasone (d); PI=proteasome inhibitor; QW=once weekly; Q2W=every 2 weeks; Q4W=every 4 weeks.
Patient characteristics1
- The median age was 67 years (range: 35–90 years); 53% were male and 89% were White, <1% were Black or African American, and <1% were Asian
- 45% had International Staging System (ISS) Stage I, 33% had ISS Stage II, and 22% had ISS Stage III disease
- Patients had received a median of 2 prior lines of therapy (range: 1–5), with 11% of patients having received 1 prior line of therapy and 75% of patients having received 2 to 3 prior lines of therapy
- All patients received a prior treatment with a proteasome inhibitor (PI) and lenalidomide, and 56% of patients received prior autologous stem cell transplant (ASCT)
- The majority of patients were refractory to lenalidomide (80%), a PI (48%), or both an immunomodulatory agent and a PI (42%)
DARZALEX FASPRO® + Pd delivered significantly improved progression-free survival (PFS) in relapsed or refractory multiple myeloma vs Pd alone1
CI=confidence interval; DPd=DARZALEX FASPRO® (D) + pomalidomide (P) + dexamethasone (d); HR=hazard ratio; Pd=pomalidomide (P) + dexamethasone (d); PFS=progression-free survival.
Safety profile for DARZALEX FASPRO® + Pd vs Pd alone
Adverse reactions reported in ≥10% of patients and with at least a 5% greater frequency in the DARZALEX FASPRO® + Pd arm in APOLLO.1
Pd=pomalidomide (P) + dexamethasone (d).
aFatigue includes asthenia and fatigue.
bEdema peripheral includes edema, edema peripheral and peripheral swelling.
cPneumonia includes atypical pneumonia, lower respiratory tract infection, pneumonia, pneumonia aspiration, pneumonia bacterial and pneumonia respiratory syncytial viral.
dUpper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tonsillitis, upper respiratory tract infectio and viral upper respiratory tract infection.
eCough includes cough and productive cough.
fOnly grade 3 adverse reactions occurred.
gGrade 5 adverse reactions occurred, n=3 (2.0%) in the DARZALEX FASPRO® + Pd arm and n=2 (1.3%) in the Pd arm.
- The most common adverse reactions (≥20%) were fatigue, pneumonia, upper respiratory tract infection, and diarrhea1
- Serious adverse reactions occurred in 50% of patients who received DARZALEX FASPRO® + Pd. The most frequent serious adverse reactions in >5% of patients who received DARZALEX FASPRO® + Pd were pneumonia (15%) and lower respiratory tract infection (12%). Fatal adverse reactions occurred in 7% of patients who received DARZALEX FASPRO® + Pd1
- Permanent treatment discontinuation due to an adverse reaction occurred in 2% of patients who received DARZALEX FASPRO® + Pd1
Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO® + Pd vs Pd alone in APOLLO1
Pd=pomalidomide (P) + dexamethasone (d).
aDenominator is based on number of subjects with a baseline and post-baseline laboratory value for each laboratory test: n=148 for DARZALEX FASPRO® + Pd and n=149 for Pd.
NCCN Guidelines recommendations for daratumumab-containing regimens