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ACTIVE NOT RECRUITING
NCT01562405
PHASE1

Sotatercept (ACE-011) With Lenalidomide or Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

ACE-011

Injection every 28 days, dose escalation levels from 15-45 mg

DRUG

Lenalidomide

15 to 25 mg days 1-21, given orally

DRUG

Dexamethasone

40 mg days 1,8,15,22; given orally

DRUG

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