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

NCT01562405 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Multiple Myeloma Research Consortium

    collaborator NETWORK

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Andrew J. Yee, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562405 on ClinicalTrials.gov