Περίληψη:
This phase IIa study evaluated the safety and tolerability of
sotatercept, and its effects on bone metabolism and haematopoiesis in
newly diagnosed and relapsed multiple myeloma (MM) patients. Patients
were randomized (4:1) to receive four 28-d cycles of sotatercept (01,
03, or 05mg/kg) or placebo. Patients also received six cycles of
combination oral melphalan, prednisolone, and thalidomide (MPT). Thirty
patients were enrolled; six received placebo and 24 received
sotatercept. Overall, 25% of patients received all four sotatercept
doses; 71% of sotatercept-treated patients had 1 dose interruption
mainly due to increases in haemoglobin levels. Grade 3 adverse events
(AEs) were reported in 17% of patients receiving placebo and 58%
receiving sotatercept. Grade 4 AEs in sotatercept-treated patients were
neutropenia, granulocytopenia, and atrial fibrillation (one patient
each). In patients without bisphosphonate use, anabolic improvements in
bone mineral density and in bone formation relative to placebo occurred,
whereas bone resorption was minimally affected. Increases in haemoglobin
levels, versus baseline, and the duration of the increases, were higher
in the sotatercept-treated patients, with a trend suggesting a
dose-related effect. Multiple doses of sotatercept plus MPT appear to be
safe and generally well-tolerated in MM patients.
Συγγραφείς:
Abdulkadyrov, Kudrat M.
Salogub, Galina N.
Khuazheva, Nuriet K.
and Sherman, Matthew L.
Laadem, Abderrahmane
Barger, Rachel and
Knight, Robert
Srinivasan, Shankar
Terpos, Evangelos
