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Sotatercept (ACE-011) With Lenalidomide or Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma
Sponsor: Massachusetts General Hospital
Summary
It is possible that the combination of lenalidomide, dexamethasone and ACE 011 may reduce or prevent the growth of cancer cells along with improving anemia and bone lesions that sometimes occur in people with multiple myeloma. This current study is the first study combining ACE 011 with lenalidomide. In this research study, the investigators are looking for the highest dose of ACE 011 that can be given with lenalidomide and dexamethasone. The investigators will also begin to collect information about the effect of the combination of ACE 011, lenalidomide and dexamethasone on multiple myeloma.
Official title: Phase 1, Multicenter, Open-label, Dose-escalation Study of Sotatercept (ACE-011) in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2012-05
Completion Date
2027-12
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
ACE-011
Injection every 28 days, dose escalation levels from 15-45 mg
Lenalidomide
15 to 25 mg days 1-21, given orally
Dexamethasone
40 mg days 1,8,15,22; given orally
Pomalidomide
Pomalidomide 4 mg daily on days 1-21
Locations (4)
Emory University
Atlanta, Georgia, United States
Massachusetts General Hosptial
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States