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Lenalidomide 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose of ACE-011
Secondary outcome measures
Efficacy of ACE-011
Pharmacodynamic markers
Pharmacodynamic measures
+1 moreTrial 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
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,295 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,242 Patients Enrolled for Multiple Myeloma
Massachusetts General HospitalLead Sponsor
2,937 Previous Clinical Trials
13,199,017 Total Patients Enrolled
35 Trials studying Multiple Myeloma
2,605 Patients Enrolled for Multiple Myeloma
Andrew J. Yee, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
1 Trials studying Multiple Myeloma
Frequently Asked Questions
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