Study Design
- Phase 2, open-label, multicentre study
-
Patients randomized 1:1 to receive daratumumab
- 8 mg/kg every 4 weeks, or
- 16 mg/kg every week for 8 weeks, every 2 weeks for 16 weeks, then every 4 weeks thereafter
- Response was evaluated at first interim
analysis and 16 mg/kg daratumumab was
established as the recommended dose for
further study
- Results are reported for all patients who
were treated with 16 mg/kg
daratumumab (n = 106)
Inclusion Criteria
- 18 years of age
- Documented secretory multiple
myeloma and evidence of
disease progression
- Responded to at least one
previous treatment regiment
- Received ≥ 3 prior lines of
therapy including a proteasome
inhibitor (PI) and an
immunomodulatory drug (IMiD),
or have disease refractory to
both a PI and IMiD
- Received an alkylating agent
alone or in combination with
other myeloma treatments
- Absolute neutrophil count >1 x 109/L
- Hemoglobin > 7.5 g/dL
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Platelet count ≥ 50 x 109/L
- Creatinine clearance > 20 ml/min/1.73 mm2
Exclusion Criteria
- Any anti-myeloma treatment within 2 weeks
- Autologous stem cell transplantation within 12 weeks
- Meningeal involvement of multiple myeloma and other malignancies within 5 years
- Myocardial infarction within 1 year
- Uncontrolled or unstable angina
- Congestive heart failure
(NYHA Class III or IV)
- Arrhythmia (≥ grade 2)
- QTcF interval > 470 ms
- Chronic obstructive pulmonary disease
- Persistent or a history of asthma within 5 years
Efficacy Endpoints
- Primary Endpoint
- Overall response rate (ORR)
- ORR = Stringent complete response (sCR) + complete
response (CR) + very good partial response (VGPR) + partial
response (PR)
- Secondary Endpoint
- Duration of response
- Progression-free survival (PFS)
- Overall survival (OS)
- Clinical benefit rate (minimal response [MR] + ORR)
Safety
- Safety assessments included:
- Monitoring of adverse events (AEs)
- Physical examinations
- Electrocardiogram monitoring
- Clinical laboratory measurements
- Vital sign measurements
- ECOG performance status