Trial Design

The first phase 3 trial evaluating a CD38-directed monoclonal antibody + Pd vs Pd alone

Trial Design Baseline Characteristics

A multicenter, open-label, randomized, phase 3 study in patients with relapsed refractory multiple myeloma1

Patients with relapsed refractory multiple myeloma who received at least 2 prior therapies, including lenalidomide and a PI

Randomized 1:1 (N=307)

SARCLISA + Pd
(n=154)

Pd
(n=153)

  • SARCLISA 10 mg/kg was administered as an IV infusion weekly in the first cycle and every 2 weeks thereafter
  • Treatment administered in 28-day cycles until disease progression or unacceptable toxicity

Primary endpoint: PFS

Key secondary endpoints: ORR, OS

  • Pomalidomide 4 mg was taken orally once daily from day 1 to day 21 of each 28-day cycle. Low-dose dexamethasone (orally or IV) 40 mg (20 mg for patients ≥75 years of age) was given on days 1, 8, 15, and 22 for each 28-day cycle1
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Baseline characteristics

Baseline characteristics (N=307)1

Median patient age
67 y
(range 36-86)
≥75 y
20%
History of COPD or asthma
at study entry
10%
Renal impairment (creatinine clearance <60 mL/min/1.73 m2)
34%
ISS stage at study entry
 
Stage I
37%
Stage II
36%
Stage III
25%
Patients with high-risk chromosomal
abnormalities at study entry
20%
del(17p)
12%
t(4;14)
8%
t(14;16)
2%
Median number of prior lines
of therapy
3 (range 2-11)
Received prior PI
100%
Received prior lenalidomide
100%
Received prior stem cell
transplantation
56%
Refractory to lenalidomide
93%
Refractory to a PI
76%
Refractory to both an
immunomodulator and a PI
73%

In the trial population1

93% of patients
were refractory to lenalidomide

20% of patients
had high-risk chromosomal abnormalities at study entry

34% of patients
had renal impairment

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COPD=chronic obstructive pulmonary disease; ISS=International Staging System; IV=intravenous; ORR=overall response rate; OS=overall survival; Pd=pomalidomide and dexamethasone; PFS=progression-free survival; PI=proteasome inhibitor.

View Trial Results