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Sotatercept Combination Therapy for Multiple Myeloma

Phase 1
Waitlist Available
Led By Andrew J. Yee, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Monoclonal plasma cells in the bone marrow > 10% and/or presence of a biopsy-proven plasmacytoma
Patient must have received at least 1 line of prior systemic therapy for the treatment of multiple myeloma. A line of treatment is sequential treatment without interruption for response and subsequent progression
Must not have
Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ACE 011, Lenalidomide or Dexamethasone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat multiple myeloma.

Who is the study for?
This trial is for adults with multiple myeloma who've had at least one prior treatment. They must not be pregnant or breastfeeding, have a decent level of physical function (ECOG 0-2), and show specific signs of the disease in their blood, urine, or bone marrow. Those needing recent radiotherapy should wait two weeks post-treatment to join.
What is being tested?
Researchers are testing Sotatercept (ACE-011) combined with Lenalidomide and Dexamethasone to find the highest safe dose against multiple myeloma. This study aims to see if this combo can slow cancer growth while helping anemia and bone issues related to the disease.
What are the potential side effects?
Possible side effects include reactions where the drug enters the body, changes in blood pressure or heart rate, fatigue, risk of infections due to low white blood cell counts, bleeding issues from low platelets, and potential harm to unborn babies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bone marrow has more than 10% plasma cells or I have a confirmed plasmacytoma.
Select...
I have had at least one full course of treatment for my multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have brain metastases.
Select...
I have allergies to medications similar to ACE 011, Lenalidomide, or Dexamethasone.
Select...
I do not have any serious illnesses that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose of ACE-011
Secondary study objectives
Efficacy of ACE-011
Pharmacodynamic markers
Pharmacodynamic measures
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ACE-011 (sotatercept)Experimental Treatment4 Interventions
ACE-011, Lenalidomide or pomalidomide, Dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACE-011
2008
Completed Phase 2
~30
Pomalidomide
2011
Completed Phase 2
~1020
Lenalidomide
2005
Completed Phase 3
~2240
Dexamethasone
2007
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,313 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,260 Patients Enrolled for Multiple Myeloma
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,249 Total Patients Enrolled
36 Trials studying Multiple Myeloma
2,958 Patients Enrolled for Multiple Myeloma
Andrew J. Yee, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
1 Trials studying Multiple Myeloma
~0 spots leftby Dec 2024
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